Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2019 – 30.06.2019

Опубліковано 01.07.2019 о 15:58

Швейцарія

https://fsca.swissmedic.ch/mep/#/

 

7.06.2019

(Updated02.07.2019)

Intuitive Surgical, Inc

da Vinci Xi EndoWrist SureForm 60 Reload 
Model: 48360T-08, 48360G-08 
Lot: See FSN

MD: Surgical staple loading unit, non-cutting

DE-1 
EN-1 

Vk_20190614_12

21.06.2019

(Updated02.07.2019)

Dexcom, lnc.

G4 Platinum System 
Model: All receivers – applies to product generation

Dexcom G5 Mobile 
Model: All receivers – applies to product generation

MD: Percutaneous glucose monitoring system

MD: Percutaneous glucose monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190522_15

01.07.2019

GE Healthcare Finland Oy

ECG trunk cables

ECG Leadwire

MD: Electrical-only medical device connection cable, reusable

MD: Electrocardiographic lead set, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190627_10

25.06.2019

(Updated01.07.2019)

KeyMed Medical & Industrial Equipment

Nurses Control Panel Arm – Long 
Model: MAJ-1664, K10021798 
Lot: All lot numbers prior to 606852

MD: Medical device integration rack

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190621_22

01.07.2019

Bracco Injeneering S.A.

Day Set III HP 
Model: 640060 
Lot: 2018091403, 2018092003, 2018092004, 2019031101, 2019031601, 2019041904

MD: Contrast medium injection system syringe

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190619_17

27.06.2019

(Updated28.06.2019)

REPROLIFE

Warming Solution Set 205 (Solutions) 
Lot: See Annex

Warming Kit 102 (Solutions + Plate) 
Lot: See Annex

Vitrification Solution Set 110 (Solutions) 
Lot: See Annex

Vitrification Kit 101 (Solutions + Plate + Cryotec) 
Lot: See Annex

Value Pack LL (VK101x47, WK102x47) 
Lot: See Annex

Value Pack SS (VK101x4, WK102x4) 
Lot: See Annex

MD: IVF medium kit

MD: IVF medium kit

MD: IVF medium kit

MD: IVF medium kit

MD: IVF medium kit

MD: IVF medium kit

EN-2 

Vk_20190523_18

03.06.2019

(Updated28.06.2019)

EKF-diagnostic GmbH

Quo-Lab A1c Test Kit 
Model: 0055 
Lot: See FSN

IVD: Glycated haemoglobin (HbA1c) IVD, reagent

DE-1 
FR-1 
EN-1 

Vk_20190522_18

28.06.2019

(Updated28.06.2019)

Dietz Reha-Produkte

Ligero 
Model: 322NPU/323NPU 
S/N: 346V XXXXXX with production date 2014-2018

MD: Leichtgewicht-Rollator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190507_10

03.04.2019

(Updated28.06.2019)

Roche Diagnostics GmbH

BILD2 (Bilirubin direct Gen.2) 
Model: 05168384190 
Lot: 33798101, 35714101

cobas c 701 / 702

IVD: Conjugated (direct) bilirubin IVD, kit, spectrophotometry

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

FR-1 
EN-1 
EN-2 

Vk_20190329_14

13.03.2019

(Updated28.06.2019)

BioFire Diagnostics, LLC

FilmArray Gastrointestinal (GI) Panel 
Model: RFIT-ASY-0104 / RFIT-ASY-0116 
Lot: All lots with expiration date of 23 October 2019 onward

IVD: Multiple Parameters – Infect. Immunology

DE-2 
FR-2 
EN-1 
EN-2 
EN-3 

Vk_20190306_16

25.06.2019

(Updated27.06.2019)

Stöpler Instrumenten & Apparaten B.V.

COCUNE – Feuchte Waschhandschuhe (parfümiert/unparfümiert) 
Model: CCN 21-1001, CCN 21-1002, CCN 21-1004, CCN 21-1005 
Lot: 03102, 03192, 03188,

MD: wash gloves

DE-1 
FR-1 
IT-1 
EN-2 

Vk_20190624_17

27.06.2019

Datascope Corp.

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump 
Model: 0998-00-0800-XX, 0998-UC-0800-XX, 0998-00-3013-XX, 0998-00-3023-XX;N/A 
Lot: N/A 
S/N: All Cardiosave serial numbers distributed March 6, 2012 to present All CS100 and CS300 serial numbers distributed March 24, 2003 to present 
SW-Version: N/A

MD: Intra-aortic balloon pump

EN-1 

Vk_20190619_15

26.06.2019

Horiba ABX SAS

Yumizen H1500

Yumizen H2500

IVD: Haematology analyser, cell differential

IVD: Haematology analyser, cell differential

EN-1 

Vk_20190621_15

26.06.2019

Roche Diagnostics GmbH

MYO2 (Tina-quant Myoglobin Gen.2) 
Model: 04580010190 
Lot: see FSN

IVD: Myoglobin IVD, kit, chemiluminescent immunoassay

EN-1 

Vk_20190621_05

26.06.2019

Siemens Healthcare GmbH

Artis Zee

Artis Q

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

DE-1 
FR-1 

Vk_20190621_04

26.06.2019

Immundiagnostik AG

IDKmonitor lnfliximab total ADA, IDKmonitor Adalimumab total ADA, Remsima Monitor total ADA, 25(OH)-Vitamin D direct day ELISA, 25(OH)-Vitamin D dried blood ELISA, PreventlD Cardiac Troponin I, PreventlD Vital-D 
Model: see FSN 
Lot: all

IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)

EN-1 

Vk_20190621_01

25.06.2019

Biomet Orthopedics

Comprehensive Reverse Shoulder Instrument Case 
Model: 595509, 595510 
Lot: All Lots

MD: Instrument tray

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190624_18

25.06.2019

Abbott

Ellipse VR/DR 
Model: CD2377-36QC, CD2377-36C, CD1377-36QC, CD1377-36C 
S/N: See attached List of affected serial numbers

AIMD: Implant, cardiac pacemaker

EN-1 

Vk_20190621_16

24.06.2019

MEDOS Medizintechnik AG

Deltastream DP3 Pumphead in support.set Säuglinge, hilite 800 LT, rheoparin beschichtet, Modell Medos (Schlauchset MEH2C4024) 
Model: 190104M354 
Lot: 190104M354

MD: Cardiopulmonary bypass system centrifugal pump

EN-1 

Vk_20190617_14

24.06.2019

Siemens Healthcare Diagnostics Inc

Stratus CS Acute Care cTnI TestPak

IVD: Troponin kit

FR-1 
EN-1 

Vk_20190612_14

18.06.2019

(Updated21.06.2019)

Natus Medical Denmark, GN Otometrics A/S

Chartr EP 200 
Model: See FSN 
S/N: All

MD: Auditory stimulator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190617_05

21.06.2019

(Updated21.06.2019)

Intrinsic Therapeutics Inc.

Barricaid 
Model: 2730815-EU, 2731015-EU, 2731215-EU, Catalogue: BAR-D8-8X14, BAR-D8-10X14, BAR-D8-12X14 
Lot: all

MD: Lumbar total disc replacement prosthesis

DE-1 
FR-1 
EN-1 

Vk_20190614_04

21.06.2019

Dedienne Santé

orientation guide SYMBOL CUP Instrum

SYMBOL STEM Instrument

ADES Instrument

SHIVA Instrument

TRICCC Instrument

SMS Instruments

MD: Orthopaedic prosthesis implantation instrument, reusable

MD: Acetabular orthopaedic reamer

MD: Acetabulum prosthesis trial, reusable

MD: Femoral head prosthesis trial

MD: Femoral stem prosthesis trial

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190614_02

21.06.2019

ES-Medical AB

C-10 Probetester 
Model: T80002 
S/N: 0710003 – 1705001, 17080001 – 1801014

MD: Test and disinfection equipment for probes

DE-1 
DE-1 

Vk_20190529_14

04.06.2019

(Updated21.06.2019)

Covidien LLC

Endo GIA, Surgical Stapling Single Use Loading Units, Tri-Staple 2.0 
Model: EGIA30AMT, EGIA45CTAMT, EGIA60AXT, EGIA60CTAMT, SIG30AMT, SIG45AXT, SIG45CTAMT, SIG60AXT, SIG60CTAMT, EGIA45AMT, EGIA60AMT 
Lot: see FSN

MD: Surgical staple, non-biodegradable

DE-2 
FR-2 
IT-2 
EN-1 

Vk_20190529_09

19.06.2019

(Updated20.06.2019)

Ortho-Clinical Diagnostics, Inc

ORTHO AutoVue Innova / Ultra, ORTHO VISION / VISION Max 
Model: VISION: 6904579, VISION Max: 6904578, AutoVue Innova: 707010, AutoVue Ultra: 6902058

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

EN-1 
EN-2 

Vk_20190613_02

20.06.2019

Abbott GmbH & Co. KG

Alinity ci-series System Control Module 
Model: 03R70-01 
S/N: all

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190612_07

19.06.2019

Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis Zee

AXIOM Artis systems

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

DE-1 
FR-1 
IT-1 

Vk_20190617_11

19.06.2019

Critical Diagnostics

Presage ST2 Assay 
Model: BC-1065E 
Lot: All 
S/N: n/a 
SW-Version: n/a

IVD: Other Cardiac Markers

EN-1 

Vk_20190614_14

18.06.2019

EMED SP. Z O.O. SP. K.

RF electrosurgical unit for arthroscopy 
Model: 11010042

MD: Electrosurgical Units

DE-1 
FR-1 
EN-1 

Vk_20190617_17

18.06.2019

DIAsource

VIP RIA (Vasoactive intestinal polypeptide) 
Model: RB311, RB311RUO 
Lot: 191601

IVD: Vasointestinal Peptide

EN-1 

Vk_20190613_15

18.06.2019

Magnisense

MiAG|cTnI 
Model: 10030201

IVD: Troponin I/T

EN-1 

Vk_20190611_02

28.05.2019

(Updated18.06.2019)

Medtronic MiniMed

Guardian Connect Application 
Model: CSS7200 
SW-Version: Versions prior v3.2.4

MD: Patient health record information system application software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190527_26

29.01.2019

(Updated17.06.2019)

MAQUET Cardiovascular LLC

AXIUS Blower Mister 
Model: CB-1000 
Lot: 96255605, 96255607, 96255608, 96255609, 96255611; Expanded lot numbers: 96255614, 96255615, 96255616, 96255617, 96255618, 96255619, 96255620, 96255621, 96255622, 96255623

MD: Surgical irrigation tubing set, single-use

EN-1 
EN-2 

Vk_20190128_05

12.06.2019

(Updated14.06.2019)

Roche Diabetes Care GmbH

Accu-Chek Insight 
S/N: All

MD: Ambulatory insulin infusion pump, electronic

DE-1.1 
DE-1.2 
FR-1.1 
FR-1.2 
IT-1.1 
IT-1.2 
EN-1.1 
EN-1.2 

Vk_20190606_13

13.06.2019

DiaMed GmbH

DiaClon Rh-Subgroups + K 
Model: 50110 // 50115; 001397 / 001398 // 002124 / 002127 / 002126 / 002125 
Lot: All lot numbers until further notice 
S/N: NA 
SW-Version: NA

IVD: Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination

EN-1 

Vk_20190605_15

13.06.2019

Abbott Laboratories

ARCHITECT Complement C3; ARCHITECT Immunoglobulin A; ARCHITECT Immunoglobulin G; ARCHITECT Immunoglobulin M; ARCHITECT Apolipoprotein A1; ARCHITECT Complement C4; ARCHITECT Haptoglobin; ARCHITECT Apolipoprotein B; ARCHITECT Transferrin

IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)

EN-1 

Vk_20190605_10

07.06.2019

(Updated13.06.2019)

Datascope Cardiac Assist Division

SENSATION PLUS 7.5Fr. 40cc IAB 
Model: 0684-00-5658-01 
Lot: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828

MD: Intra-aortic balloon pump

DE-1 
FR-1 
EN-1 

Vk_20190603_04

12.06.2019

Roche Diagnostics GmbH

cobas 8800 System 
Model: 05412722001 
S/N: n.a. 
SW-Version: n.a.

cobas 6800 System 
Model: 05524245001 
S/N: n.a. 
SW-Version: n.a.

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

EN-1, Diagnostic 
EN-1, Screening 

Vk_20190611_05

12.06.2019

Randox Laboratories Ltd

Assayed Bovine Multi-Sera – Level 1 
Model: AL1027 
Lot: 205SL

IVD: Multiple clinical chemistry analyte IVD, control

EN-1 

Vk_20190607_06

12.06.2019

Aesculap AG

DISP.FLEECE DRAPE 
Model: F/GA419/GD417/GD421

MD: Multi-purpose surgical power tool system, line-powered

DE-1 
EN-1 

Vk_20190606_14

12.06.2019

Hologic, Inc.

Aptima Combo 2 Assay 
Model: Panther: 302923, 303094. Tigris: 301130

IVD: Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

EN-1 

Vk_20190604_12

05.06.2019

(Updated12.06.2019)

TEC COM GmbH

TECOTHERM NEO 
Lot: all 
S/N: all

MD: Warming/cooling unit, patient

DE-1 
FR-1 
IT-1 

Vk_20190529_05

11.06.2019

Teleflex Medical

Pleur Evac 
Model: S-1100-08LF / S-1200-08LF S-1200-08LF 
Lot: As per FSN appendix

MD: Thoracic suction collection container

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190605_12

11.06.2019

Pennine Healthcare Ltd

Feeding Tubes 
Lot: see fsn

Levin Tubes 
Lot: see fsn

Neleton Catheters 
Lot: see fsn

Rectal Catheter 
Lot: see fsn

Ryles tube 
Lot: see fsn

Stomach Tubes 
Lot: see fsn

Suction Catheters 
Lot: see fsn

Medical Pack 
Lot: see fsn

MD: Nasoenteral tube

MD: Gastrointestinal tube

MD: Urine-sampling urethral catheter

MD: Rectal tube

MD: Nasogastric feeding tube

MD: Tube, stomach evacuator

MD: Tracheal suction catheter

MD: General/plastic surgical procedure kit, non-medicated, single-use

EN-1 
EN-2 

Vk_20190603_13

11.06.2019

William Cook Europe ApS

Advance Enforcer 
Model: ASB5-35-50-6-4, ASB5-35-80-6-4, ASB5-35-135-6-4 
Lot: 9234424, 9331618, 9212015, 9243035, 9320430, 9386804, 9338194, 9234423, 9278982

MD: Peripheral angioplasty balloon catheter, basic

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190603_07

28.05.2019

(Updated11.06.2019)

Philips Medical Systems

HeartStart MRx Defibrillator/ Monitor 
Model: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9, M3539A AC Power Module

MD: Rechargeable professional automated external defibrillator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190524_13

17.12.2018

(Updated11.06.2019)

Ethicon Endo-Surgery, LLC

PROXIMATE HCS Hemorrhoidal Circular Stapler 
Model: PPH01, PPH03 
Lot: See FSN

MD: Haemorrhoidal surgical stapler, single-use

DE-1.0 
FR-1.0 
EN-1.0 

Vk_20181207_04

07.06.2019

Teleflex Medical

Sheridan Close Fitting Endotracheal Tube

Sheridan Endotracheal Tube

Sheridan HVT Endotracheal Tube

Sheridan HVT EZ-Endo Endotracheal Tube

Sheridan Preformed Endotracheal Tube

Sheridan Uncuffed Endotracheal Tube

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190528_15

05.06.2019

(Updated07.06.2019)

Thermo Fisher Scientific Oy

ALT/GPT (IFCC) 
Model: 981769 and 981361 
Lot: all

LDH (IFCC) 
Model: 981906 
Lot: all

LDH (SCE) 
Model: 981781 and 981383 
Lot: all

alpha-HBDH 
Model: 981380 
Lot: all

Creatine Kinase (IFCC) 
Model: 981828 and 981829 
Lot: all

Glucose (Hexokinase) without sample blank 
Model: 981779 and 981304 
Lot: all

IVD: Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

IVD: Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry

IVD: Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry

IVD: Alpha-hydroxybutyrate dehydrogenase IVD, kit, enzyme spectrophotometry

IVD: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

IVD: Glucose kit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190523_15

28.05.2019

(Updated07.06.2019)

Medtronic Inc.

My Therapy App for Sacral Neuromodulation Therapy 
Model: A510 
SW-Version: All

AIMD: Perineal orifice incontinence-control electrical stimulation system

DE-1 
FR-1 
EN-1 

Vk_20190521_19

07.06.2019

Novak M d.o.o.

Therapy chair Zero G 
Model: TCZ-LUX 
S/N: 32260513-2018

MD: Therapy chair for long lasting treatment

DE-1 
FR-1 
EN-1 

Vk_20190510_01

05.06.2019

(Updated06.06.2019)

Abbott

Alinity i BNP Calibrator 
Model: see FSN 
Lot: see FSN

Alinity i BNP Control 
Model: see FSN 
Lot: see FSN

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

EN-1 
EN-2 

Vk_20190528_11

29.05.2019

(Updated06.06.2019)

Quidel Corporation

MicroVue C4d Fragment EIA 
Model: A008 
Lot: 134472

IVD: Complement Activation

DE-1 
EN-1 

Vk_20190527_24

28.05.2019

(Updated06.06.2019)

Roche Diagnostics GmbH

Elecsys Syphilis (200 test/kit) 
Model: 07802960190

IVD: Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

FR-1 
EN-1 

Vk_20190524_05

15.05.2019

(Updated06.06.2019)

Arkray Factory, Inc.

AUTION HYBRID AU-4050 
Model: 14602 
Lot: N/A 
S/N: All 
SW-Version: Ver.00-03 – Ver.00-16

IVD: Urine analyser IVD, laboratory, automated

DE-2 
EN-1 
EN-2 

Vk_20190510_12

13.08.2018

(Updated06.06.2019)

Beckman Coulter, Inc.

UniCel DxH 900 Coulter Cellular Analysis System 
Model: see FSN 
S/N: All 
SW-Version: all

UniCel DxH 600 Coulter Cellular Analysis System 
Model: see FSN 
S/N: All 
SW-Version: all

UniCel DxH 800 Coulter Cellular Analysis System 
Model: see FSN 
S/N: All 
SW-Version: all

IVD: Haematological cell analyser IVD, automated

IVD: Haematological cell analyser IVD, automated

IVD: Haematological cell analyser IVD, automated

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

Vk_20180802_25

05.06.2019

Becton, Dickinson and Company

BD Microtainer tube 
Model: 365964, 365966, 365968, 365975, 365979, 365986, 365988, 365993 
Lot: see FSN

IVD: Specimen container, general-purpose

EN-1 

Vk_20190604_03

05.06.2019

Qiagen GmbH

QIAsymphony Filter Tips 
Model: 997024 
Lot: 0605020019, 0605020020, 0635020002, 0635020003

IVD: SP Hardware + accessories + consumables + software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190604_01

05.06.2019

Bard Access Systems Inc

EQUISTREAM, EQUISTREAM XK, GLIDEPATH 
Model: see FSN 
Lot: refer to FSN

MD: Double-lumen haemodialysis catheter, implantable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190603_19

05.06.2019

Abbott Laboratories

ARCHITECT BNP Calibrator 
Model: see FSN 
Lot: see FSN

ARCHITECT BNP Control 
Model: see FSN 
Lot: see FSN

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

EN-1 

Vk_20190528_07

28.05.2019

(Updated05.06.2019)

Primed Halberstadt Medizintechnik GmbH

Sinapi Thoraxdrainage-Systeme 
Model: 70130 XS 50; 70132 XL1000SC 
Lot: See FSN

MD: Thoracic suction collection container

DE-1 
FR-1 
IT-1 

Vk_20190527_17

28.05.2019

(Updated05.06.2019)

Abbott

Alinity ci-series System Control Module 
Model: 03R70-01 
S/N: all 
SW-Version: Alinity ci Software V2.6.0 and V2.5.1

Alinity c Processing Module 
Model: 03R67-01

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

DE-1 
FR-1 
EN-1 

Vk_20190523_10

28.05.2019

(Updated05.06.2019)

Phadia AB

EliA RF IgM Well 
Model: 14-5600-01 
Lot: 0085/CJY2D

IVD: Rheumatoid factor IVD, kit, fluorescent immunoassay

DE-1 
FR-1 
EN-1 

Vk_20190521_16

05.06.2019

Medtronic Inc.

Astra 
Model: X2DR01, X3DR01, X2SR01, X3SR01 
Lot: all

Azure 
Model: W2DR01, W2SR01 
Lot: all

Percepta 
Model: W1TR04, W4TR04 
Lot: all

Serena 
Model: W1TR05, W4TR05 
Lot: all

Solara 
Model: W1TR06, W4TR06 
Lot: all

AIMD: Dual-chamber implantable pacemaker, rate-responsive

AIMD: Single-chamber implantable pacemaker, rate-responsive

AIMD: Cardiac resynchronization therapy implantable pacemaker

AIMD: Cardiac resynchronization therapy implantable pacemaker

AIMD: Cardiac resynchronization therapy implantable pacemaker

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190513_09

04.06.2019

GE Healthcare

Centricity Universal Viewer with Centricity PACS Foundations

MD: Medical image management system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190603_15

04.06.2019

GE Vingmed Ultrasound AS

Vscan Extend

MD: General-purpose ultrasound imaging system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190529_13

04.06.2019

GE Healthcare

Centricity Universal Viewer

MD: Medical image management system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190529_12

04.06.2019

GE Medical Systems SCS

Senographe Pristina and Pristina Serena 
S/N: See FSN

MD: Stationary mammographic x-ray system, digital

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190529_10

04.06.2019

GE Healthcare Integrated IT Solutions

Centricity PACS-IW 
SW-Version: 3.6.0 to 3.7.3.9 SP1, SP2, SP3; 3.7.3 SPa10

MD: Radiology picture archiving and communication system application software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190529_06

28.05.2019

(Updated04.06.2019)

Roche Diagnostics GmbH

cobas e 601 module, cobas e 602 module, MODULAR ANALYTICS E combinations, MODULAR ANALYTICS EVO E combinations

AssayTip / AssayCup 
Model: 12102137001 
Lot: 19817113, 19818113

IVD: Immunoassay Analyser

IVD: IC&II Hardware + accessories + consumables + software

DE-1 
FR-1 
EN-1 

Vk_20190522_14

21.05.2019

(Updated04.06.2019)

Medtronic Navigation Inc.

O-ARM 1000 Imaging System 
Model: See FSN 
S/N: All

MD: Portable general-purpose fluoroscopic x-ray system, digital

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190516_10

03.06.2019

EKOS Corporation inc.

EKOS Control System 4.0

MD: Ultrasound thrombolysis system control unit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190527_03

28.05.2019

(Updated03.06.2019)

Roche Diagnostics GmbH

IGA-2 (Tina-quant IgA Gen.2) 
Model: 05219205190 
Lot: 368756

IVD: Immunoglobulin A kit

DE-1 
FR-1 
EN-1 

Vk_20190522_21

04.03.2019

(Updated03.06.2019)

MAQUET Cardiopulmonary GmbH

Pre-Bypass Filter 
Model: 70102.1039; 70102.1040; 70103.1084; 70103.1086 
Lot: Please refer to Annex I 
S/N: N/A 
SW-Version: N/A

MD: Cardiopulmonary bypass system tubing set

DE-1.0 
IT-1.0 
EN-1.0 

Vk_20190219_12

31.10.2018

(Updated30.05.2019)

Medtronic Navigation Inc.

Synergy Cranial, StealthStation Cranial 
Model: 9733763, 9735585 
S/N: All of below listed software versions (see section 8) 
SW-Version: see section 8 comments for details

MD: Neurological stereotactic surgery system

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 
EN-2.0 

Vk_20181022_23

29.05.2019

Randox Laboratories Ltd

HUMAN ASSAYED MULTI-SERA Level 2 
Model: HN1530 
Lot: 1306UN, 1308UN, 1309UN

IVD: Multiple clinical chemistry analyte IVD, control

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190527_29

28.05.2019

PREVOR

DIPHOTERINE 
Model: MICRO-DAP, MINI-DAP

MD: Solution, irrigating, non-injectable

DE-1 
FR-1 
IT-1 

Vk_20190524_01

28.05.2019

REGENYAL Laboratories S.R.L.

REGENYAL IDEA BODY 1x20ml

MD: Biological tissue reconstructive material

EN-1 

Vk_20190522_09

28.05.2019

Edwards Lifesciences LLC

Intro-Flex Percutaneous Sheath Introducers 
Model: I355BF9 
Lot: 61409005, 61409006, 61417169, 61446317, 61446318, 61446332, 61446333, 61468596, 61481228, 61481229, 61481230 and 61494718. 
S/N: N/A 
SW-Version: N/A

MD: Vascular catheter introduction set

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190521_21

16.05.2019

(Updated28.05.2019)

Leonhard Lang GmbH

Mindray defibrillation electrodes 
Model: MR62 
Lot: See FSN

Weinmann defibrillation electrodes 
Model: WM 40116, WM 45418 
Lot: See FSN

MD: Electrodes, Cardiac, External Defibrillator

MD: Electrodes, Cardiac, External Defibrillator

DE-1- Mindray 
DE-1- Weinmann 
FR-1 – Mindray 
FR-1 – Weinmann 
IT-1 – Mindray
IT-1 – Weinmann 
EN-1- Mindray 
EN-1- Weinmann 

Vk_20190516_06

28.05.2019

Abiomed Europe GmbH

Impella Guidewire 0.018″ 
Model: 0052-3005

MD: Cardiac/peripheral vascular guidewire, single-use

DE-1 
FR-1 
IT-1 

Vk_20190510_04

28.03.2019

(Updated28.05.2019)

B. Braun Melsungen AG

Connection Lead SP (12V) 
Model: 8713231 
Lot: From 40/17 to 43/18 and From 07/19 to 16/19

MD: Electrical-only medical device connection cable, reusable

DE-1 
DE-2 
EN-1 

Vk_20190325_04

11.12.2018

(Updated28.05.2019)

LivaNova USA, Inc.

VNS Therapy SenTiva Generator 
Model: 1000 
S/N: All below 100’000

AIMD: Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system

DE-1 
DE-2 
FR-1 
FR-2 
IT-1 
IT-2 
EN-1 
EN-2 

Vk_20181205_01

22.05.2019

(Updated27.05.2019)

bioMérieux SA

VIDAS NT-proBNP2 
Model: 30458 
Lot: 1007078560

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA)

FR-1 
EN-1 

Vk_20190517_03

27.05.2019

Gambro Lundia AB

Prismaflex System 
Model: 114870, 113874, 107493, 106913, 955052, 114489, 113082 
S/N: All serial numbers with software 8.10 
SW-Version: 8.10

MD: Haemodialysis system, institutional

DE-1 
FR-1 

Vk_20190515_08

22.05.2019

(Updated27.05.2019)

Olympus Medical Systems Corp.

EVIS LUCERA DUODENOVIDEOSCOPE 
Model: TJF-160VR; N1425530 & E0425505 
S/N: All

MD: Flexible video duodenoscope, reusable

DE-1 
DE-2 
FR-1 
FR-2 
IT-1 
IT-2 
EN-1 
EN-2 

Vk_20190507_12

27.05.2019

Cook Endoscopy

Hemospray Endoscopic Hemostat 
Model: HEMO-7-EU, HEMO-10-EU

MD: Inorganic haemostatic agent, sterile

DE-1 
FR-1 
IT-1 

Vk_20190205_11

27.05.2019

Cook Incorporated

Vacuum Pump KMAR-5200 
Lot: All lots

MD: General-purpose suction system, line-powered

DE-1.0 
FR-1.0 
IT-1.0 

Vk_20180319_01

26.03.2018

(Updated27.05.2019)

Gambro Dialysatoren GmbH

Ultrafilter U9000 
Model: 112062 
Lot: From 6-1907-H-01 and higher

MD: Microbial water purification filter, sterilizable

DE-1.0 
DE-2.0 
FR-2.0 

Vk_20180314_01

22.05.2019

(Updated24.05.2019)

Abbott

Alinity c Complement C3 Reagent Kit 
Model: 09P5620 
Lot: all Lots

Alinity c Immunoglobulin A Reagent Kit 
Model: 09P6120 
Lot: all Lots

Alinity c Immunoglobulin G Reagent Kit 
Model: 09P6220 
Lot: all Lots

Alinity c Immunoglobulin M Reagent Kit 
Model: 09P6320 
Lot: all Lots

Alinity c Apolipoprotein A1 Reagent Kit 
Model: 09P4620 
Lot: all Lots

Alinity c Complement C4 Reagent Kit 
Model: 09P5720 
Lot: all Lots

Alinity c Haptoglobin Reagent Kit 
Model: 09P5920 
Lot: all Lots

Alinity c Apolipoprotein B Reagent Kit 
Model: 09P4720 
Lot: all Lots

Alinity c Transferrin Reagent Kit 
Model: 08P3820 
Lot: all Lots

IVD: Complement components C3/C3c IVD, reagent

IVD: Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

IVD: Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

IVD: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

IVD: Apolipoprotein A-I (Apo A1) IVD, reagent

IVD: Complement components C4/C4c IVD, reagent

IVD: Haptoglobin IVD, reagent

IVD: Apolipoprotein B (Apo B) IVD, reagent

IVD: Transferrin IVD, kit, nephelometry/turbidimetry

DE-1 
FR-1 
EN-1 

Vk_20190520_07

24.05.2019

Neuromedex GmbH

SECURODRAIN / NeuroVac Silikon-Flachdrainage 
Model: 21-0411 
Lot: 81038

MD: Drains, Wound

DE-1 
FR-1 

Vk_20190514_12

22.05.2019

(Updated24.05.2019)

bioMérieux

Chocolate agar + PolyViteX 
Model: 43109 
Lot: 1007089110 
S/N: N/A 
SW-Version: N/A

IVD: Factors X/V chocolate agar culture medium IVD

DE-1 
FR-1 
EN-1 

Vk_20190514_07

24.05.2019

Getinge – Maquet GmbH

QUADROX-i Neonatal Microporous Membrane Oxygenator 
Model: 701049279 
Lot: 92261621

MD: Extracorporeal membrane oxygenator

FR-1 
EN-1 

Vk_20190510_19

23.01.2019

(Updated24.05.2019)

Dako North America, Inc.

Dako Autostainer Slide Racks 
Model: S3704

IVD: Microscope slide stainer IVD

DE-1 
FR-1 
EN-1 

Vk_20190117_12

01.05.2019

(Updated23.05.2019)

DiaMed GmbH

IH-QC1 
Model: 08710; 009321 
Lot: All lots currently in date

IVD: Multiple immunohaematology test IVD, control

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190426_12

22.05.2019

Fluoron GmbH

Brilliant Peel 
Model: G-81010 
Lot: BP 0.5S 300718

MD: Eye dye

DE-1 
FR-1 
IT-1 

Vk_20190522_07

22.05.2019

Siemens Healthcare Diagnostics Inc.

Atellica and ADVIA Creatine Kinase (CK_L) Reagent 
Model: see FSNs 
Lot: see FSNs

IVD: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

DE-1 (Advia) 
DE-1 (Atellica) 
EN-1 (Advia) 
EN-1 (Atellica) 

Vk_20190516_12

22.05.2019

Qiagen GmbH

RNeasy DSP FFPE Kit 
Model: 73604 
Lot: 163016105

IVD: Other Other Genetic Tests

DE-1 
FR-1 
IT-1 

Vk_20190514_13

14.05.2019

(Updated22.05.2019)

Olympus Medical Systems Corp.

OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE 
Model: TJF-Q190V 
S/N: All

OLYMPUS EVIS LUCERA ELITE DUODENOVIDEOSCOPE 
Model: TJF-Q290V 
S/N: All

MD: Flexible video duodenoscope, reusable

MD: Flexible video duodenoscope, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190510_13

07.05.2019

(Updated22.05.2019)

Covidien LLC

Mahurkar Triple Lumen Catheter 
Model: see FSN 
Lot: All

Mahurkar Dual Lumen Catheter 
Model: see FSN 
Lot: All

Argyle Single Lumen Catheter 
Model: see FSN 
Lot: All

MD: Triple-lumen haemodialysis catheter

MD: Double-lumen haemodialysis catheter, nonimplantable

MD: Single-lumen haemodialysis catheter, peripheral vascular

DE-1 
FR-1 
EN-1 

Vk_20190506_09

21.05.2019

Terumo Cardiovascular Systems

Electronic Patient Gas System Flowmeter – APS1 
Model: 801188 
Lot: All March 29, 2019

MD: Cardiopulmonary bypass system, roller type

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190516_16

21.05.2019

Micro-Mega SA

X-Cid2 
Model: X-CID2 230V EUR EMB;51100003 
S/N: Unknown

MD: Dental handpiece maintenance unit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190516_07

21.05.2019

TORNIER SAS

Non sterile pin guide 
Model: MWE157, MWB319, MJU093 
Lot: 18B792, 18C696, 18D493, 19A141

MD: Drilling power tool attachment, basic

DE-1 
FR-1 
IT-1 

Vk_20190514_01

20.05.2019

Xhale Assurance, Inc

Nasal Alar SpO2 Sensor 
Model: 0303, 0201-A01 
Lot: 101624 – 101842

MD: Pulse oximeter probe, single-use

DE-1 
FR-1 
EN-1 

Vk_20190513_04

17.05.2019

Sinapi Biomedical (Pty) Ltd

Sinapi Chest Drain 
Model: XL200, XL200S, XL200SC, XL1000, XL1000S, XL1000SC, XL2000S, XL2000SD

MD: Pleural drainage system

EN-1 

Vk_20190516_09

23.04.2019

(Updated17.05.2019)

Philips Medical Systems

IntelliVue MX40 Patient Monitor 
Model: See FSN 
SW-Version: See FSN

MD: Single-patient physiologic monitoring system

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

Vk_20190423_16

03.04.2019

(Updated17.05.2019)

Randox Laboratories Ltd

G-6-PDH Control Deficient and Normal 
Model: PD2617, PD2618 
Lot: 687PD, 700PD, 715PD, 676PD, 701PD, 716PD

G-6-PDH 
Model: PD410 
Lot: all

IVD: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control

IVD: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry

DE-1 
FR-1 
IT-1 
IT-2 
EN-1 
EN-2 

Vk_20190401_27

05.12.2018

(Updated17.05.2019)

Roche Diagnostics GmbH

Bilirubin Total Gen.3 
Model: see FSN

Lactate 
Model: see FSN

LACT2 
Model: see FSN

IgM-2 
Model: see FSN

IVD: Total bilirubin IVD, kit, spectrophotometry

IVD: Lactate IVD, kit, enzyme spectrophotometry

IVD: Lactate IVD, kit, enzyme spectrophotometry

IVD: Immunoglobulin M kit

DE-1 
DE-2 
FR-1 
FR-2 
IT-1 
IT-2 
EN-1 
EN-2 A 
EN-2 B 

Vk_20181203_01

28.06.2018

(Updated17.05.2019)

Radiometer Medical ApS

ABL800 
Model: 393-800, 393-801 
S/N: All 
SW-Version: Software versions 6.14 to 6.18

IVD: Metabolic profile clinical chemistry analyser IVD, stationary, automated

DE-1 
DE-2 
FR-1 
FR-2 
IT-1 
IT-2 
EN-1 
EN-2 

Vk_20180620_03

16.05.2019

I.T.S. GmbH

Rim Platte, 10-Loch, Links, PRS RX System 
Model: 21206-10 
Lot: 26/F42778

MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

DE-1 
EN-1 

Vk_20190509_07

16.05.2019

Von Ardenne Institut für Angewandte Medizinische Forschung GmbH

IRATHERM1000 
S/N: 001/01/94 bis 118/12/15 
SW-Version: V4.1

MD: Warming Units, Patient

DE-1 
FR-1 
EN-1 

Vk_20190508_06

16.05.2019

Fluoron GmbH

F-Decalin 
Model: G-80115, G-80117 
Lot: See FSN

F-Octane 
Model: G-80315, G-80317 
Lot: See FSN

MD: Vitreous/aqueous humour replacement medium, intraoperative

MD: Vitreous/aqueous humour replacement medium, intraoperative

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190426_07

12.04.2019

(Updated16.05.2019)

Medset Medizintechnik GmbH

PADSY-Holter 
Model: Sirius, Antares 
Lot: AAG118111, AAG118121 
SW-Version: from Version 7.5a

MD: Holter ECG Analysis System

DE-1 
DE-2 
FR-1 
IT-1 
EN-1 
EN-2 

Vk_20190405_12

15.05.2019

Siemens Healthcare GmbH

ARTIS Icono Biplane 
S/N: 180003, 180004

MD: Stationary angiographic x-ray system, digital

DE-1 

Vk_20190513_10

14.05.2019

Philips Medical Systems Ultrasound Inc.

EPIQ Ultrasound System 
Model: 795200, 795201, 795202, 795203, 795204, 795205, 795206, 795207, 795208, 795209, 795210, 795211, 795117, 795118, 795119, 795218, 795231, 795232, 795233, 795120

Affiniti Ultasound System 
Model: 795200, 795201, 795202, 795203, 795204, 795205, 795206, 795207, 795208, 795209, 795210, 795211, 795117, 795118, 795119, 795218, 795231, 795232, 795233, 795120

MD: General-purpose ultrasound imaging system

MD: General-purpose ultrasound imaging system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190510_22

14.05.2019

Medical Service GmbH

Mobile SL, Ergothan 
Model: 580012G CH 12, 580014G CH 14, 580114G CH 14 
Lot: 1745228, 17/45/228, 1743203, 17/43/203, 1817202, 18/17/202, 1738207, 17/38/207

MD: Single-administration urethral drainage catheter

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190509_06

14.05.2019

Pfizer Consumer Health Care

ThermaCare 
Lot: S00639

MD: Exothermic heat therapy pack

DE-1 
EN-1 

Vk_20190508_08

14.05.2019

Becton Dickinson and Company Limited

BD PhaSeal Secondary Set 
Model: C61; 515302 
Lot: 1011102, 1011095, 1011186, 1011412, 1011464, 1011580, 1011753, 1011786, 1011787

MD: Basic intravenous administration set

DE-1 

Vk_20190507_13

14.05.2019

MSP Medizintechnik GmbH

HSO Safeheat Wärmehandschuh 
Model: HSOWHAND01

MD: Wärmehandschuh

DE-1 
EN-1 

Vk_20190423_15

13.05.2019

SenTec AG

Membrane Changer 
Model: MC-R 
Lot: See FSN

Membrane Changer Insert 
Model: MC-I 
Lot: See FSN

Membrane Changer Set 
Model: MC-SET 
Lot: See FSN

SenTec Standard Starter Set 
Model: SSET 
Lot: See FSN

SenTec Standard Starter Set (without Service Gas) 
Model: SSET_nG 
Lot: See FSN

Sentec Neonatal Starter Set without gas 
Model: SSET-N_nG 
Lot: See FSN

SenTec Neonatal Starter Set 
Model: SSET-N 
Lot: See FSN

MD: Pulse Co-oximeter probe, reusable

MD: Pulse Co-oximeter probe, reusable

MD: Pulse Co-oximeter probe, reusable

MD: Transcutaneous blood gas monitoring system

MD: Transcutaneous blood gas monitoring system

MD: Transcutaneous blood gas monitoring system

MD: Transcutaneous blood gas monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190503_18

08.05.2019

(Updated13.05.2019)

Abbott Laboratories

ARCHITECT c4000 / c8000 / c16000 Mixer 
Model: 02P24; 01G06; 03L77; 
S/N: All Serial numbers

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190503_13

13.05.2019

Fresenius Vial

Orchestra Base Intensive and Orchestra Base Primea 
Model: Z0812XX and Z0813XX (see FSA enclosed)

MD: Infusion pump management unit, mobile

DE-1 
FR-1 
EN-1 

Vk_20190430_08

13.05.2019

BEAVER-VISITEC INTERNATIONAL, INC

BVI OPHTHALMIC FLUID CONTROL SPONGES 
Model: 90900, 90910, 223620, 223621, 400200, 400207, 581047,223622, 400117, 400210, 581076 
Lot: Various

MD: various

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190429_20

09.05.2019

(Updated13.05.2019)

Beckman Coulter, Inc.

Access Free T3 
Model: A13422 
Lot: all

Access Free T4 
Model: 33880 
Lot: all

Access Total T3 
Model: 33830 
Lot: all

Access Thyroglobulin Assay 
Model: 33860 
Lot: all

Access GI Monitor 
Model: 387687 
Lot: all

Access Thyroglobulin Antibody II 
Model: A32898 
Lot: all

IVD: Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

IVD: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

IVD: Reverse triiodothyronine (reverse T3) IVD, kit, chemiluminescent immunoassay

IVD: Thyroglobulin IVD, kit, chemiluminescent immunoassay

IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)

IVD: Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

DE-1 
FR-1 
EN-1 

Vk_20190426_19

28.02.2019

(Updated13.05.2019)

TransEnterix Italia S.r.l.

RADIA Adapter and Shaft for Articulated Instrument 
Model: X9000009, X0005216 
Lot: All 
S/N: All

MD: Robotic surgical system

DE-1 
FR-1 
IT-1 
IT-2 

Vk_20190220_02

10.05.2019

Institut Straumann AG

Straumann TempImplant ø 2.0mm, L 12.0mm, Ti 
Model: 80372SV4 
Lot: VK308

MD: Screw endosteal dental implant, one-piece

DE-1 
EN-1 

Vk_20190503_05

09.05.2019

Terumo Medical Corporation

SOLOPATH Re-Collapsible Balloon Access System 
Model: SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435 
Lot: all Lots (see FSN 1a)

SOLOPATH Expandable 
Model: STFI-1425, STFI-1435, STFI-1625,STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 
Lot: all Lots (see FSN 1a)

Portico Solo Re-Collapsible Access System 
Model: PRTSOLO-19,PRTSOLO-20 
Lot: all Lots (see FSN 1b)

MD: Vascular catheter introduction set

MD: Vascular catheter introduction set

MD: Vascular catheter introduction set

DE-1a 
DE-1b 
FR-1a 
FR-1b 
IT-1a 
IT-1b 
EN-1a 
EN-1b 

Vk_20190506_15

09.05.2019

Mathys Ltd Bettlach

twinSys impactor with offset 
Model: 51.34.0446 
Lot: 6054487, 6061532, 6063726, 6065504, 6066616, 6067637, 6068893, 6070147

MD: Joint prosthesis implantation kit, reusable

DE-1 
FR-1 
EN-1 

Vk_20190502_04

09.05.2019

GE Medical Systems SCS

Achilles EXP II 
S/N: See FSN

MD: Bone absorptiometric ultrasound system

DE-1 
EN-1 

Vk_20190430_13

09.05.2019

Philips Medical Systems

SureSigns VS Series Monitor 
Model: 863069, 863070, 863071, 863072, 863073, 863074, 863283, 863286 
S/N: 863071, 863072, 863073, 863074, 863283, 863286 
SW-Version: Up to and including A.07.32

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190429_12

09.05.2019

OLEA MEDICAL S.A.S.

Olea Sphere 
SW-Version: V3.0

MD: MRI and CT image processing software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190426_10

08.05.2019

Edwards Lifesciences LLC

PASCAL System 
Model: 10000IS; 10000GS 
Lot: All PASCAL Systems distributed

MD: Mitral valve clip

DE-1 
EN-1 

Vk_20190506_17

08.05.2019

Carestream Health Inc

OnSight 3D Extremity System 
S/N: Range 10013 – 20022

MD: Limited-view-field CT system

FR-1 
EN-1 

Vk_20190503_09

07.05.2019

(Updated08.05.2019)

Cook Incorporated

Kwart Retro-Inject Ureteral Stent Set 
Model: 003500, 003600, 003700, 003800, AQ-003500, AQ-003600, AQ-003700 
Lot: All

Salle Intraoperative Pyeloplasty Stent Set 
Model: SIPSF-040018-56-6, SIPSF-040018-59, SIPSF-050018-59 
Lot: All

MD: Polymeric ureteral stent

MD: Nephrostomy catheter

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190502_06

08.05.2019

Siemens Healthcare GmbH

Artis Zee 
S/N: systems delivered since Mai 2018

Artis Q/Q.zen 
S/N: systems delivered since Mai 2018

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

FR-1 
EN-1 

Vk_20190501_02

08.05.2019

Getinge Disinfection AB

Getinge 86-series 
Model: S-8666, S-8668 
S/N: All devices delivered from Manufacturing Site after 28.11.2018

MD: Washer, decontamination

DE-1 
EN-1 

Vk_20190425_02

30.04.2019

(Updated08.05.2019)

Maquet SAS

VOLISTA 
Model: STANDOP & TRIOP

MD: Operating light

DE-1 
FR-1 
EN-1 

Vk_20190424_08

07.05.2019

Gambro Industries

MARS Treatment Kit 
Model: 800540 
Lot: See FSN

OXIRIS S 
Model: 955503 
Lot: See FSN

SEPTEX Set 
Model: 112017 
Lot: See FSN

PRISMAFLEX set 
Model: 107144, 107636, 107640

MD: Bound solute dialysis system component set

MD: Haemofilter

MD: Haemofilter

MD: Haemofilter

DE-1 
FR-1 

Vk_20190501_01

02.05.2019

(Updated07.05.2019)

Abbott Vascular

MitraClip XTR Delivery System 
Model: CDS0602-XTR 
Lot: All lots

MD: Mitral valve tissue repair system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190430_01

07.05.2019

Peter Brehm Chirurgie-Mechanik e.K.

TRIAL Titanium Shell left with strap 60 mm 
Model: 54860-15-1 
Lot: 15006263

MD: Trial Prostheses, Joint, Hip

DE-1 
EN-1 

Vk_20190426_17

18.04.2019

(Updated07.05.2019)

Leonhard Lang GmbH

Schiller Defibrillationselektrode 
Model: 0-21-0003, 0-21-0020, 2.155061, 2.155065, 2.155063, 0-21-0037, 2.155067, 0-21-0040 
Lot: see FSN 
SW-Version: n.z.

MD: Electrodes, Cardiac, External Defibrillator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190411_20

02.05.2019

(Updated06.05.2019)

Tristel Solutions Limited

Tristel Rinse Wipe 
Model: TSL030301 
Lot: 832400/1

MD: Medical device disinfection wipe

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190429_14

01.05.2019

(Updated06.05.2019)

Standard Diagnostics Inc.

SD BIOLINE Chikungunya IgM 
Model: 46FK10 
Lot: 46ADB005A, 46ADB005B, 46ADC001A, 46ADC002A, 46ADC002B, 46ADC003A, 46ADC003B

IVD: Other Viral Antigen/Antibody Detection

FR-1 
EN-1 

Vk_20190429_03

06.05.2019

Aesculap AG

Caiman Maryland non Articulat.D5/360MM 
Model: PL770SU 
Lot: 52481830

MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

DE-1 
EN-1 

Vk_20190425_17

02.05.2019

(Updated06.05.2019)

BEAVER-VISITEC INTERNATIONAL, INC

Visiwipe Instrument Wipe 7.3 x 7.3 cm 
Model: 581047 
Lot: 18B0431; 18B0542; 18C0753; 18F1889; 18J2671

MD: Medical device disinfection wipe

DE-1 
FR-1 
EN-1 

Vk_20190405_09

12.12.2018

(Updated06.05.2019)

Randox Laboratories Ltd

Calcium 
Model: CA3871, CA8309, CA8021 
Lot: not lot specific

IVD: Calcium (Ca2+) IVD, kit, spectrophotometry

DE-1 
DE-2 
DE-3 
FR-1 
FR-2 
FR-3 
EN-1 
EN-2 

Vk_20181204_06

01.05.2019

(Updated03.05.2019)

Axis-Shield Diagnostics Limited

Alere NT-proBNP Control 
Model: 2R10-10, 04S7910 
Lot: 902922185, 10777UP00, 10805UP00

Alere NT-pro BNP Calibrator 
Model: 2R10-01, 04S7901 
Lot: 902922220, 10774UP00, 10801UP00

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

DE-1 
FR-1 
EN-1 

Vk_20190425_14

03.05.2019

SenoRx, Inc.

EnCor Breast Biopsy Probe 
Model: ECP0110G, ECP017G, ECP0110GV, ECP017GV, ECP0112G, ECP0112GV 
Lot: See FSN

MD: Mammographic stereotactic biopsy system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190425_04

03.05.2019

Edwards Lifesciences LLC

Miller Balloon Atrioseptostomy Catheter 
Model: 830515F 
Lot: All lots

Fogarty Dilation Atrioseptostomy Catheter 
Model: 830705F 
Lot: All lots

MD: Cardiac septostomy catheter, balloon

MD: Cardiac septostomy catheter, balloon

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190425_01

23.04.2019

(Updated03.05.2019)

MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO Radiotherapy

Tilting Head Fixation System (Solstice) 
Model: CHS03, CHS04, CHS03K, CHS03GK, CHS04K and CHS04GK 
Lot: CHS03: M602380 – DOM 6/27/18 M680480 – DOM 9/5/18 M847590 – DOM 10/29/18 M870360 -DOM 2/26/19 CHS04: M680530 – DOM 9/5/18 M789110 – DOM 10/3/18

MD: Radiological headrest

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190418_11

24.04.2019

(Updated03.05.2019)

Linkage Biosciences Inc.

SureTyper Software 
Model: STTPGRX 
SW-Version: v6.0.0

IVD: Diagnostics & Clinical Interpretation Supporting Software

DE-1 
FR-1 
EN-1 
EN-1_2 

Vk_20190417_03

08.04.2019

(Updated03.05.2019)

Grifols Diagnostic Solutions Inc.

Procleix HEV Assay 
Model: PRD-03042, PRD-02789

IVD: Hepatitis E virus nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1 
IT-1 
EN-1 

Vk_20190408_04

30.04.2019

(Updated02.05.2019)

William Cook Europe ApS

Zenith Alpha Thoracic Endovascular Graft 
Model: ZIMB-xx-xxx 
Lot: see attachment 1

MD: Synthetic vascular graft

DE-1 
EN-1 

Vk_20190426_04

24.04.2019

(Updated02.05.2019)

Biokit S.A.

QUANTIA RF 
Model: 6K44-01 
Lot: 01518H000

IVD: Rheumatoid Factors

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190418_05

25.04.2019

(Updated02.05.2019)

Steripack SA

Safety pin no. 3, 1 piece per pouch 
Model: 331016S 
Lot: 1810069

MD: Surgical instrument clip

DE-1 
FR-1 
EN-1 

Vk_20190415_03

01.05.2019

Quidel Corporation

MicroVue DPD EIA 
Model: 8007 
Lot: 132254 
SW-Version: N.A.

IVD: Deoxypyridinoline

EN-1 

Vk_20190429_19

30.04.2019

Boston Scientific Corporation

Xenform Tissue Repair Matrix 
Model: M0068302410, M0068302430, M0068302450, M0068302470

Pinnacle LITE Pelvic Floor Repair Kit 
Model: M0068318150

Polyform Synthetic Mesh 
Model: M0068402400, M0068402410

Uphold LITE Vaginal Support System with Capio SLIM 
Model: M0068318170

MD: Pelvic organ prolapse/stress urinary incontinence surgical mesh

MD: Pelvic organ prolapse surgical mesh, synthetic polymer

MD: Pelvic organ prolapse surgical mesh, synthetic polymer

MD: Pelvic organ prolapse surgical mesh, synthetic polymer

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190429_16

30.04.2019

Edwards Lifesciences LLC

EV1000 Clinical Platform System 
Model: EV1000A, EV1000NI 
S/N: ALL

MD: Patient monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190424_07

30.04.2019

TVA Medical, Inc.

everlinQ 4 endoAVF System 
Model: ELQ-002 
Lot: S0043

MD: Vascular guide-catheter, single-use

DE-1 

Vk_20190418_13

24.04.2019

(Updated30.04.2019)

Covidien LLC

Argyle Universal Green Bubble Tubing 
Model: 8888230201 
Lot: See FSN

Argyle Thoracic Catheter 
Model: 8888570549, 8888571059 
Lot: See FSN

Aryle Flexible Yankauer Catheter 
Model: 8888501007, 8888501023, 8888504001 
Lot: See FSN

Dover Silicone Foley Catheter 
Model: 8887605122, 8887605163, 8887605205, 8887630245 
Lot: See FSN

MD: Suction system tubing, single-use

MD: Multi-purpose percutaneous drainage catheter

MD: Suction system catheter, general-purpose

MD: Indwelling urethral drainage catheter

DE-1 
FR-1 
EN-1 

Vk_20190416_07

24.04.2019

(Updated29.04.2019)

Abbott

Alinity c Cuvette Segment 
Model: 04S47-01 
Lot: N/A 
S/N: all 
SW-Version: N/A

Alinity c Processing Module 
Model: 03R67-01

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

DE-1 
FR-1 
EN-1 

Vk_20190417_05

16.04.2019

(Updated29.04.2019)

Ortho Clinical Diagnostics Inc.

VITROS Chemistry Products CK Slides 
Model: 8478034, 8479396 
Lot: see fsn

IVD: Total creatine kinase (CK) IVD, reagent

DE-1 
EN-1 

Vk_20190411_03

26.04.2019

Siemens Healthcare GmbH

syngo.via 
Model: 10496180 – 10561669 and 10561495 
SW-Version: several

MD: Radiology picture archiving and communication system application software

DE-1 
FR-1 

Vk_20190416_16

26.04.2019

Smiths Medical ASD Inc

Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes 
Model: BRC270, BRC275, BRC280, BRC285, BRC290, BRCA70, BRCA75, BRCA80, BRCA85, BRCA90 
Lot: ALL 
S/N: N/A 
SW-Version: N/A

MD: Tracheostomy tube cannula, single-use

DE-1 
EN-1 

Vk_20190221_10

25.04.2019

Philips Medical Systems DMC GmbH

MobileDiagnost wDR 
Model: 712001,712002, 712004, 712005 
S/N: all

MD: Radiographic unit, mobile

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190417_13

25.04.2019

Accuray Incorporated (Madison)

CyberKnife 
SW-Version: 11.x

MD: Linear accelerator system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190416_20

25.04.2019

Willy Rüsch GmbH

Lasertube 
Model: 102004-000040, 102004-000050, 102004-000060, 102004-000070, 102004-000080 
Lot: See FSN

MD: Laser-resistant endotracheal tube

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190411_05

25.04.2019

OHST Medizintechnik AG

Ceramic femoral heads & Ceramic cup inserts

Hip prosthesis, internal, femoral component

MD: Acetabulum prosthesis

MD: Hip prosthesis, internal, femoral component

DE-1.0 
IT-1.0 
EN-1.0 

Vk_20181214_25

24.04.2019

Occlutech GmbH

Occlutech Delivery Set 
Model: 51ES006, 51ES007, 51ES008, 51ES009, 51ES010, 51ES011

MD: Cardiac occluder delivery kit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190417_10

24.04.2019

Thermo Fisher Scientific Microbiology Basingstoke

ThermoScientific Oxoid Ceftriaxone 32 M.I.C.E. 
Model: MA0122D & F 
Lot: 2380270; 2341066

IVD: MICROBIOLOGY (CULTURE)

DE-1 
FR-1 
EN-1 

Vk_20190416_21

24.04.2019

Thermo Fisher Scientific Microbiology Perth

Oxoid Bacillus Cereus Medium (MYP) 
Model: PO5133A 
Lot: 2635614

IVD: MICROBIOLOGY (CULTURE)

DE-1 
EN-1 

Vk_20190416_09

23.04.2019

AngioDynamics

Solero Microwave Tissue Ablation System Generator 
Model: H787127400000, H7877001060010, H7877001060020, H7877001060030 
S/N: multiple

MD: Microwave hyperthermia system applicator, intracorporeal

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190423_26

23.04.2019

Philips Medical Systems Nederland BV

Ingenia Ambition S 
Model: 781359

Ingenia Ambition X 
Model: 781356

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

DE-1 
EN-1 

Vk_20190416_26

23.04.2019

Topcon Corporation

IMAGEnet 6 
SW-Version: 1.00, 1.01, 1.02, 1.10, 1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, 1.20, 1.21, 1.22, 1.22.1, 1.23, 1.24

MD: Information Systems, Picture Archiving and Communication

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190416_24

23.04.2019

3M Health Care

3M Reston Self-Adhering Foam 
Model: 1560M and 1561H 
Lot: for 1560M: 3337GM; 3337HY; 3337PK; 3337T4; 3337W8; 3337XE; 33393N; 33394H; 33396C; 3339CM; 3339FC; 333AK7; 333AM6; 333AT3; 333BTX; 333BYW; 333EA7; 333ECJ; 333EEK; 333ETK; 333EYJ; 333KR7; 333KTE; 333KYR; 333LCX; 333LGA; 333N5T; 333N93; 333NLC for 1561H: 2

MD: Multifunction body cushion

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190411_13

10.04.2019

(Updated23.04.2019)

Siemens Healthcare GmbH

Cios Alpha 
Model: Cios Alpha VA30 Systems

MD: Portable general-purpose fluoroscopic x-ray system, digital

DE-1 
FR-1 
EN-1 

Vk_20190403_13

10.04.2019

(Updated23.04.2019)

Siemens Healthcare GmbH; Business Area Advanced Therapies

Cios Spin

MD: Portable general-purpose fluoroscopic x-ray system, digital

DE-1 
EN-1 

Vk_20190403_08

02.04.2019

(Updated23.04.2019)

Medtronic Inc.

Activa Clinician Programmer Application 
Model: A610 
S/N: All 
SW-Version: 1.0.3470

AIMD: Multiple active implantable device programmer

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190402_02

25.04.2018

(Updated23.04.2019)

Roche Diagnostics GmbH

Vitamin D total II, Elecsys Vitamin D total II 
Model: 07464215190, 07028148190 
Lot: n.a.

IVD: 25-Hydroxy vitamin D3 IVD, reagent

DE-1 
DE-2 
DE-3 
FR-1 
FR-2 
FR-3 
IT-3 
EN-1 
EN-2 
EN-3 

Vk_20180418_01

21.08.2017

(Updated18.04.2019)

Covidien LLC

Emprint Percutaneous Antenna with Thermosphere Technology 
Model: CA15L1, CA20L1, CA30L1, CA15L2, CA20L2, CA30L2 
Lot: See FSN

Emprint SX Navigation Antenna with Thermosphere Technology 
Model: CA15L2N, CA20L2N, CA30L2N

MD: Microwave hyperthermia system applicator, intracorporeal; Microwave ablation system probe

MD: Microwave ablation system probe

DE-1 
DE-2 
DE-3-bestehende Kunden 
DE-3-neue Kunden 
FR-1 
FR-2 
FR-3-clients existants 
FR-3-nouveaux clients 
IT-1 
IT-2 
IT-3 
EN-1 
EN-2 
EN-3 

Vk_20170814_11

16.04.2019

(Updated17.04.2019)

Olympus Surgical Technologies America

Diego Elite Power Console 
Model: EGMDCONS100 
SW-Version: UIC version 2.3.9.0 and RTC version 00.01.23

Diego Elite Shaver Blade 
Model: EGBB2000SA, EGMM4000SS, EGBB4000SS, EGBB4000SC, EGBB4040XS, EGBB4040XC, EGBB4040SS, EGBB4040SC, EGMB4000SS 
Lot: All

MD: Pneumatic arthroscopic shaver system control unit

MD: Metal/carbide ENT bur, single-use

DE-1 
EN-1 

Vk_20190409_23

17.04.2019

AtriCure, Inc.

Cobra Fusion Ablation System 
Model: 700-001S, 700-001MI, 700-002, 700-003

MD: Electrosurgical system

EN-1.0 

Vk_20190128_04

21.10.2018

(Updated17.04.2019)

Endologix International Holdings B.V.

Nellix, Endovascular Aneurysm Sealing System 
Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, N10-190, N10-200 NP-002; NP-004; NP-001; NP-003; NP-005; NX-001, NX-002a;N/A 
Lot: N/A 
S/N: N/A 
SW-Version: N/A

MD: Abdominal aorta endovascular stent-graft

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20181015_13

16.04.2019

Drägerwerk AG & Co.KGaA

Oxylog VE300 
Model: 5790200 
SW-Version: NA

MD: Transport electric ventilator

DE-1 

Vk_20190415_07

16.04.2019

Cook Incorporated

Pericardiocentesis Catheter Set 
Model: C-PCS-850 
Lot: 7703324, NS7703501, NS7703502, NS7703503, NS7704718

Thoracentesis Set 
Model: C-THS-850 
Lot: NS7662071

MD: Pericardiocentesis catheter

MD: Pleural drainage system

DE-1 
FR-1 
EN-1 

Vk_20190412_01

16.04.2019

Integra LifeSciences (Ascension Orthopedics)

Movement Great Toe System 
Model: MGT-890-10MT, MGT-890-20MT, MGT-890-30MT, MGT-890-40MT 
Lot: All

MD: Total metatarsophalangeal joint prosthesis, one-piece

DE-1 
FR-1 
EN-1 

Vk_20190411_17

16.04.2019

Quidel Cardiovascular Inc.

Quidel Triage Drug Screen Control 1 
Model: 94413 
Lot: C3470AN

IVD: Multiple therapeutic drugs/drugs of abuse IVD, control

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190411_10

16.04.2019

Biomet Orthopaedics

T7 Driver AO 
Model: 110018531, 110018541 
Lot: All Lots

MD: Surgical screwdriver, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190410_16

16.04.2019

Berchtold GmbH & Co. KG

Light Head Cover, Printed, F 528 / F628 
Model: 83282, 83283 
S/N: See FSN

MD: Lights, Surgical

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190410_09

16.04.2019

Abbott

Alinity i Processing Module 
Model: 03R65-01 
S/N: All

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
FR-1 
EN-1 

Vk_20190409_21

16.04.2019

Medos International SARL

Concorde Lift 
Model: 197809221C, 197809226C, 197811221C, 197811226C, 197809223L, 197809227L, 197811223L, 197811227L 
Lot: All lots

MD: Metallic spinal fusion cage, sterile

DE-1 
IT-1 
EN-1 

Vk_20190408_06

09.04.2019

(Updated16.04.2019)

Getinge – Maquet GmbH

MEERA with and w/o Drive Unit 
Model: 720001B2, 720001B0, 720001F2, 720001F0, 710001B2, 710001B0, 710001F0 
S/N: 720001B2: SN 1 – SN 416, 720001B0: SN 1 – SN 1416, 720001F2: SN 1 – SN 91, 720001F0: SN 1 – SN 220, 710001B2: SN 1 – SN 8, 710001B0: SN 1 – SN 11, 710001F0: SN 1

MD: Universal operating table, electrohydraulic

DE-1 
FR-1 
EN-1 

Vk_20190402_09

15.04.2019

BD Switzerland Sàrl

MaxZero Needleless Connector 
Model: MZ1000, MZ1000-07, MZ1000 CHINA, MZ5301, MZ5302, MZ5303, MZ5304, MZ5305, MZ5306, MZ5307, MZ5308, MZ5309, MZ5310, MZ5312, MZ5313, MZ5316, MZ8001, MZ8002, MZ8003, MZ9226, MZ9265, MZ9266, MZ9267, MZ9270, MZ9271, MZ9272, MZ9273, MZ9274, MZ9275, MZ9276, MZ9277 
Lot: All

MD: Intravenous administration tubing extension set

DE-1 
FR-1 
EN-1 

Vk_20190404_10

08.04.2019

(Updated15.04.2019)

Samsung Electronics Co., Ltd

GM85 
Model: GM85 
Lot: all 
S/N: all

MD: Mobile basic diagnostic x-ray system, digital

DE-1 
FR-1 
EN-1 

Vk_20190402_12

15.04.2019

BIOSYNEX

Palutop +4 Optima 
Lot: all

IVD: Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid

FR-1.0 
EN-1.0 

Vk_20190318_08

12.04.2019

Zimmer Biomet GmbH

Alpha Durasul Inlay GG/32 
Model: 01.00013.407 
Lot: 2975251

MD: Non-constrained polyethylene acetabular liner

DE-1 
FR-1 
EN-1 

Vk_20190412_10

12.04.2019

Mölnlycke Health Care AB

XRD swabs

MD: Neurosurgical procedure kit, non-medicated, single-use

DE-1 

Vk_20190405_14

12.04.2019

BEKA Hospitec GmbH

Alu CARLO Classic 
Model: 924002000

MD: Mobile patient lifting system, battery-powered

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190405_11

04.04.2019

(Updated12.04.2019)

Stryker GmbH

TACTYS – IPP Prosthesis -Proximal Surface 
Model: Size L WIPSP11; Size M WIPSP10 
Lot: Y23259 (Size L); Y23263 (Size M)

MD: Proximal interphalangeal joint prosthesis, modular

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190403_01

11.04.2019

EKOS Corporation inc.

EKOS Control System 4.0 – Connector interface cabl 
Model: 700-10410 
Lot: 180918052; 181116028 
S/N: 180918052-012; 181116028-003; 181116028-005; 181116028-006; 181116028-007; 181116028-014; 181116028-016; 181116028-019

MD: Ultrasound thrombolysis system control unit

DE-1 
EN-1 

Vk_20190405_08

11.04.2019

Invacare Deutschland GmbH

BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM 
S/N: 626 Dynamic Controls’ Shark Power Modules with SN range: A18217618 – H18199840

MD: Wheelchairs, Powered

DE-1 
EN-1 

Vk_20190401_24

02.04.2019

(Updated11.04.2019)

Fresenius Medical Care AG & Co. KGaA

Granumix plus 
Model: F00003333

DIAMIX 
Model: 8002571, 8001571, 8004571, 8003571, 8006571, 8005571, 8008571, 8009571, F00001840, F00004888, F00003372, F00003384, F00003386

MD: Haemodialysis system fluid mixer

MD: Haemodialysis concentrate

DE-2 
FR-2 
IT-2 
EN-1 

Vk_20190329_03

31.10.2018

(Updated11.04.2019)

Iris Diagnostics, a Division of Iris International

iChem VELOCITY Urine Chemistry Strips 
Model: 800-7212, 800-7204 
Lot: see FSN

IVD: Urine rapid test device, multiple-constituent

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

Vk_20181024_11

10.04.2019

ASSAmed GmbH

Sauerstoffkatheter CH 10 
Model: SKKS.10 
Lot: 226.808

MD: Catheters, Nasal, Oxygen Supply

DE-1 

Vk_20190408_15

10.04.2019

Dornier MedTech GmbH

Dornier Stadard Diode

Nd:YAG Lightguides

MD: laser fibers

MD: laser fibers

DE-1 
EN-1 

Vk_20190405_15

10.04.2019

Weinmann Emergency Medical Technology GmbH + Co.KG

Medumat Transport 
Model: WM 28415, WM 28315

MEDUMAT Standard 
Model: WM 22510, WM 22810

MODUL Oxygen 
Model: WM 22175

MODUL Combi 
Model: WM 22177

ULMER KOFFER 
Model: WM 8715, WM 8635, WM 3693, WM 5225

MD: Transport electric ventilator

MD: Transport electric ventilator

MD: Transport electric ventilator

MD: Transport electric ventilator

MD: Transport electric ventilator

DE-1 
EN-1 

Vk_20190404_17

10.04.2019

(Updated10.04.2019)

Siemens Healthcare GmbH

Cios Alpha 
Model: Cios Alpha VA20 Systems

MD: Portable general-purpose fluoroscopic x-ray system, digital

DE-1 
FR-1 
EN-1 

Vk_20190328_04

02.04.2019

(Updated09.04.2019)

Abbott – Thoratec Corporation

HeartMate3 Outflow Graft, HeartMate3 LVAS Kit 
Model: 105581INT, 106524INT LVAS Kit

AIMD: Implantable ventricular circulatory assist system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190402_01

03.04.2019

(Updated09.04.2019)

Edwards Lifesciences LLC

Vamp Optima 
Model: MHD8VLTW, MHD8VRL5 and VOPTIMAL 
Lot: All lots for models listed.

MD: Arterial blood sampling kit

DE-1 
FR-1 
EN-1 

Vk_20190329_13

02.04.2019

(Updated09.04.2019)

Nobel Biocare AB

Single-patient use drills for NobelReplace, Guided Start Drills/Counterbores and Guided Counterbores for NobelReplace, Implant Retrieval Instruments, Abutment Screw Retrieval Instruments 
Model: see fsn 
Lot: see fsn

MD: Fixture/appliance dental drill bit, Bone tap, Dental implant extractor, Screw extractor, Dental implant/prosthesis surgical procedure kit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190328_01

01.04.2019

(Updated08.04.2019)

Zimmer GmbH

Foot and Ankle Inst. (Drill / Tap and Countersink) 
Model: See FSN, Annex 2 
Lot: All batches manufactured by Normed Medizin Technik

MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

DE-1_dist 
DE-1_user 
DE-2_dist 
DE-2_user 
FR-1_dist 
FR-1_user 
FR-2_dist 
FR-2_user 
IT-1_dist 
IT-1_user 
IT-2_dist 
IT-2_user 
EN-1_dist 
EN-1_user 

Vk_20190328_14

08.04.2019

Biotronik AG

Cruiser 
Model: 351461 & 351468 
Lot: 06183710 & 06182718 
S/N: – 
SW-Version: –

MD: Cardiac/peripheral vascular guidewire, single-use

EN-1 

Vk_20190327_08

28.03.2019

(Updated08.04.2019)

DiaMed GmbH

IH-Com Kit Fullversion 
Model: 009000 
SW-Version: All versions

IH-Com Kit For Reader 
Model: 009010 
SW-Version: All versions

IVD: Laboratory instrument/analyser application software IVD

IVD: Laboratory instrument/analyser application software IVD

DE-1 
EN-1 

Vk_20190322_03

02.04.2019

(Updated05.04.2019)

Mölnlycke Health Care AB

Mölnlycke Detachable EndoRetrieval Pouch 
Model: 899103-01 
Lot: 6251809030

MD: Tissue extraction bag

DE-1 
FR-1 
EN-1 

Vk_20190329_08

04.04.2019

Thommen Medical AG

Adapter for handpiece, guided reusable, for guide 
Model: 3.04.090 
Lot: 17415

MD: Surgical screwdriver, reusable

DE-1_distributor 
DE-1_enduser 
EN-1_distributor 

Vk_20190328_11

20.03.2019

(Updated04.04.2019)

Leica Biosystems Nussloch GmbH

Leica Biosystems Cryostats 
Model: see FSN 
S/N: see FSN

IVD: Cryostat microtome

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190318_11

03.04.2019

GE Medical Systems Israel, Functional Imaging

Discovery NM 630, Discovery NM/CT 670 CZT, Discovery NM/CT 670 DR, Discovery NM/CT 670 ES, Optima NM/CT 640, NM 830, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR

MD: Stationary gamma camera system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190327_16

27.03.2019

(Updated03.04.2019)

Synthes GmbH

Femoral Neck System Insert for Insertion Handle 
Model: 03.168.009 
Lot: 170009-102, 170009-103, 170009-104, 170009-105, 170330-101, 170330-102, 170330-103

MD: Orthopaedic implantation sleeve, reusable

DE-1 
IT-1 
EN-1 

Vk_20190326_13

28.03.2019

(Updated03.04.2019)

Fresenius Kabi AG

CompoStop Systeme 
Model: PD51600, PT52600 
Lot: See FSN

MD: Blood donor set, double-pack, Blood donor set, triple-pack

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190325_38

02.04.2019

Datex-Ohmeda, Inc (GE Healthcare)

Aisys CS2 
SW-Version: 11SP01, 11SP02

Aisys 
SW-Version: 11SP01, 11SP02

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190401_30

02.04.2019

Dräger Medical AG & Co.

Breathing circuits VentStar Helix 
Model: See attached FSN with material number list

MD: Tubing

DE-1 
EN-1 

Vk_20190401_28

02.04.2019

A.R.C. Laser GmbH

Wolf mit der Wellenlänge 445nm 
SW-Version: Chip combination V1.3

MD: Lasers

DE-1 

Vk_20190401_26

02.04.2019

Datex-Ohmeda, Inc

Panda iRes Warmer 
S/N: See FSN

Giraffe Warmer 
S/N: See FSN

MD: Infant warmer

MD: Infant warmer

DE-1 
FR-1 
IT-1 

Vk_20190401_22

02.04.2019

ViewRay Inc.

MRIdian Linac System 
Model: 20000

MD: Stereotactic teletherapy radionuclide system, MRI-imaging

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190328_03

02.04.2019

Brainlab AG

RT Elements 
Model: Cranial SRS 1.0.0/1.5.0; Spine SRS 1.0.0/1.5.0; Multiple Brain Mets; SRS 1.5.0; RT QA 1.0.0/1.5.0 
Lot: N/A 
S/N: N/A

MD: Radiation therapy software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190326_09

02.04.2019

Hoggi GmbH

CLEO 
Model: 3279-0028 
S/N: 201849983, 201849911, 201850901, 201851893, 201850755. 201851914, 201853689, 201853690, 201854605

MD: Wheelchairs

DE-1 
EN-1 

Vk_20190322_07

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