Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2018 – 28.04.2018

06.04.2018

(Updated04.05.2018)

Abbott – Thoratec Corporation

Heartmate III 
Model: 106524INT HM3 LVAS Kit 
S/N: All serial numbers

AIMD: Implantable ventricular circulatory assist system

DE-1 
FR-1 
EN-1 

Vk_20180406_18

03.05.2018

Vital Healthcare Sdn. Bhd.

Tubing Sets for Hemodialysis / NovaLine 
Model: See FSN 
Lot: All lots manufactured in year 2017: “2017XXXXXXXX”

MD: Hemodialysis Tubing Sets

FR-1 

Vk_20180425_05

25.04.2018

(Updated03.05.2018)

Alere Technologies AS

Alere Afinion ACR Control 
Model: 1116046 
Lot: 10193874; 10195699; 10195060

IVD: Microalbumin IVD, control

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180420_05

26.03.2018

(Updated03.05.2018)

Philips Medical Systems

Philips HS1 A 
Model: M5066A, M5067A, M5068A

Philips HeartStart FRx AED 
Model: 861304, 861305

MD: Non-rechargeable public automated external defibrillator

MD: Non-rechargeable public automated external defibrillator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180319_02

02.05.2018

Samsung Electronics Co., Limited

GC80 
Model: GC80; DGR-C25U2J/US

MD: Stationary basic diagnostic x-ray system, digital

EN-1 

Vk_20180430_01

02.05.2018

Roche Diagnostics GmbH

MagNA Pure 24 System 
Model: 07290519001; 07613336106174 
Lot: n/a 
S/N: n/a

IVD: Nucleic acid sample preparation instrument IVD, automated

EN-1 

Vk_20180427_10

01.05.2018

B. Braun Melsungen AG

Askina Calgitrol Paste 
Model: 6241505 / 5547016 
Lot: all

Askina Gel 
Model: 001419S / 2159360 
Lot: all

MD: Cavity-wound management dressing, antimicrobial

MD: Cavity-wound management dressing, antimicrobial

DE-1 
FR-1 
IT-1 

Vk_20180423_14

25.04.2018

(Updated01.05.2018)

Roche Diagnostics GmbH

Combur-Test UX, Chemstrip 10 A 
Model: see FSN

Urisys 1100 
Model: see FSN

IVD: Urine rapid test device, multiple-constituent

IVD: Urine analyser IVD, laboratory, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180420_08

30.04.2018

K2M Inc.

Cascadia Interbody System 
Model: See FSN 
Lot: See FSN

MD: Vertebral body prosthesis, sterile

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180423_08

25.04.2018

(Updated27.04.2018)

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 
FR-1 
EN-1 

Vk_20180418_01

23.04.2018

(Updated27.04.2018)

Intuitive Surgical, Inc

da Vinci Xi EndoWrist Stapler 45 Reload 
Model: Blue 48645B-03, Green 48445G-03 
Lot: M11160202 till L10180107, M10151014 and M11160601 till M11180221

MD: Surgical staple, non-bioabsorbable

DE-1 
FR-1 
EN-1 

Vk_20180416_01

19.04.2018

(Updated27.04.2018)

RaySearch Laboratories AB

RayStation 
Model: 6 (RayPlan 2), 7 (RayPlan 7)

MD: Radiation therapy software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180409_06

27.04.2018

Cardiac Pacemakers, Inc, (Boston Scientific Corporation)

INGEVITY MRI 
Model: 7740, 7741, 7742

AIMD: Pacemaker/defibrillator lead

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20170928_11

26.04.2018

Konica Minolta Inc.

Fingerclip Sensor of PULSOX-300 Series 
Model: SR-5C (Art CH8196)

MD: Pulse oximeter probe, reusable

DE-1 
FR-1 

Vk_20180420_16

25.04.2018

(Updated26.04.2018)

Abbott

Implantable Cardioverter Defibrillators 
Model: See FSN

AIMD: Cardiac pulse generator software

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

Vk_20180418_07

26.04.2018

ConvaTec Limited

AbViser AutoValve Pressure Monitoring Device 
Model: ABV300, ABV301, ABV601 
Lot: All

: Intra-abdominal pressure measurement set, electronic

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

Vk_20180410_20

25.04.2018

Stryker Trauma Kiel

T2 Nailing System 
Model: see fsn

MD: Arthrodesis, Tibia and Femur nail, sterile

EN-1 

Vk_20180423_15

25.04.2018

Philips Medical Systems Nederland BV

Multidiagnost Eleva, MultiDiagnost Eleva with Flat Detector and UroDiagnost Eleva systems. 
Model: 708032, 708033, 708034, 708035, 708036, 708037, 708038

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180423_05

25.04.2018

ENDALIS

END BALL 
Model: END T110 
Lot: 17-0096

MD: Appetite-suppression gastric balloon

FR-1 

Vk_20180419_11

24.04.2018

IBL International GmbH

Progesterone Luminescence Immunoassay 
Model: RE62021_RE62029 
Lot: LPR145; LPR146; LPR147; LPR148

IVD: Progesterone kit

DE-1 
FR-1 

Vk_20180418_03

17.04.2018

(Updated23.04.2018)

Arrow International Inc.

Various Arrow Products 
Model: see FSN 
Lot: see FSN

MD: Products for Catheter navigation, Catheters, Catheter Accessories, Syringes and Needles, Surgical Drapes

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180413_07

13.04.2018

(Updated23.04.2018)

BD Switzerland Sàrl

Alaris SMARTSITE ADD-ON BAG ACCESS DEVICE 
Model: 10013365-0006 
Lot: 15055147, 15065148, 15065656, 15075252, 15075795, 15076168, 15085110, 15085157

MD: Fluid transfer set, general-purpose

DE-1 
EN-1 

Vk_20180410_10

27.03.2018

(Updated23.04.2018)

Ethicon Endo-Surgery, LLC

ENDOPATH XCEL Trocars with OPTIVIEW Technology 
Model: Product code: 2B5ST, 2B5LT, 2B5XT, 2CB5ST, 2CB5LT; Kit code: LSR278 
Lot: with expiration dates between September 2022 through January of 2023; Kit Lot Number: 10064703, 10064715, 10064728, 10064749

MD: Laparoscopic access cannula, single-use

DE-1 
FR-1 
EN-1 

Vk_20180323_15

23.04.2018

Synthes GmbH

Epoca Revision Set 
Model: 03.401.072 & 03.401.077 
Lot: For PN 03.401.072: 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949; For PN 03.401.077: 10-4566

MD: Orthopaedic implant inserter/extractor

DE-1 
EN-1 

Vk_20180320_01

11.04.2018

(Updated20.04.2018)

Becton, Dickinson and Company

BD Vacutainer EDTA tubes, BD Vacutainer Lithium Heparin tubes 
Model: See FSN 
Lot: All

IVD: Blood collection tube, evacuated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180406_16

14.03.2018

(Updated20.04.2018)

Micro Therapeutics, Inc.

MindFrame Capture LP 
Model: 300010, 300011, 300012, 300013 
Lot: All

MD: Thrombectomy suction catheter

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

Vk_20180228_06

09.04.2018

(Updated19.04.2018)

Promedical AG

Yankauer Absaugrohr/TATA/Yankauer suction tube 
Model: TA-TAYT-10-203 
Lot: P-7424; P-7937; P-9866; P-12070; P-12202; P-12173; P-6850; P-7432 P-10438

MD: Cannulae, Aspirating

DE-1 
DE-2 

Vk_20180305_19

18.04.2018

Phadia AB

EliA Intrinsic Factor Well 
Model: 14-5668-01 
Lot: 0015

IVD: Intrinsic factor antibody IVD, kit, fluorescent immunoassay

DE-1 
FR-1 
EN-1 

Vk_20180416_17

18.04.2018

Nihon Kohden Corp.

Celltac G 
Model: MEK-9100 
S/N: see FSN 
SW-Version: < 01-15

IVD: Haematology analyser, cell differential

DE-1 
EN-1 

Vk_20180413_23

18.04.2018

Philips Healthcare (Suzhou) Co.Ltd

T5, T10-NT, ACSNT, Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T, Ingenia CX 1.5T and Panorama 1.0T systems

MD: Full-body MRI system, superconducting magnet

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180412_05

18.04.2018

Siemens Healthcare Diagnostics Inc.

ADVIA Chemistry Systems Urea Nitrogen (UN) Reagent 
Model: 10309051 
Lot: 408143, 418290

IVD: Blood Urea Nitrogen (BUN) IVD, kit, enzyme spectrophotometry

DE-1 
EN-1 

Vk_20180412_02

17.04.2018

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Logiq 9, Logiq E9

MD: General ultrasound imaging system, line-powered

DE-1 
FR-1 
IT-1 

Vk_20180417_05

17.04.2018

Zimmer, Inc.

Segmental System Proximal Femoral Component 
Model: 38mm 
Lot: See FSN (Attachment 2)

MD: Revision uncoated hip femur prosthesis

FR-1 
EN-1 

Vk_20180416_08

17.04.2018

Covidien LLC

EEA Hemorrhoid and Prolapse Stapler Set with DST 
Model: HEM3335, HEM3348 
Lot: Refer to table in FSN

MD: Haemorrhoidal surgical stapler, single-use

DE-1 
EN-1 

Vk_20180416_05

17.04.2018

Genicon

EZee Retrieval 
Model: 550-000-000 
Lot: I8095/2017-11-08, I8162/2018-01-09, I8162/2020-01-09

MD: Tissue extraction bag

EN-1 

Vk_20180416_04

17.04.2018

Zimmer, Inc.

ZNN and M/DN Guide Wires 
Lot: See FSN (Attachment 2)

MD: Orthopaedic prosthesis implantation instrument (reusable and single-use); Orthopaedic bone wire

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180411_06

17.04.2018

LAP GmbH Laser Applikationen

APOLLOblue (24V) 
Model: APOLLOblue laser systems delivered with a FW7660M/24 power supply plug of the series GPP10 by FRIWO Gerätebau GmbH manufactured from calendar week 50/2013 to calendar week 23/2014 
Lot: 4513O, 4613O, 4713O, 4813O, 5113O, 5213O, 0114O, 0214O, 0314O, 0414O, 0514O, 0614O, 0714O, 0814O, 0914O, 1014O, 1114O, 1214O, 1314O, 1414O, 1514O, 1614O, 1714O, 1814O, 1914O, 2014O, 2114O, 2214O, 2314O 
S/N: AP-KB: SN0011418, SN0011417, AP-LB: SN0004621

MD: Laser Beam Imaging Media

DE-1 
EN-1 

Vk_20180410_21

17.04.2018

Tornier, Inc.

Aequalis Humerail Nail Drill Bit Sterile 
Model: 7020140 
Lot: see FSN

MD: Orthopaedic prosthesis implantation instrument, single-use

DE-1 
FR-1 
IT-1 

Vk_20180410_12

17.04.2018

Hepro AS

Sister assistance for Gripo 
Model: 35148 
S/N: hanging grip sold / delivered from Hepro in the period 1.8.2017 – 15.1.2018

MD: Hanging grip

EN-1 

Vk_20180410_11

17.04.2018

GE Vingmed Ultrasound AS

Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, Vivid E95

MD: Cardiovascular ultrasound imaging system

DE-1 
FR-1 
IT-1 

Vk_20180410_06

11.04.2018

(Updated17.04.2018)

Becton, Dickinson and Company

BD Vacutainer Plus Citrate tube 
Model: 363048 
Lot: 7298982

IVD: Evacuated blood collection tube IVD, sodium citrate

DE-1 
FR-1 
EN-1 

Vk_20180404_03

04.04.2018

(Updated17.04.2018)

Medical Econet GmbH

Cardio M and Cardio M Plus 
S/N: All Cardio M (all serial numbers), Cardio M plus from production start in 2009 Serial number T2…. up to and including serial number starting with T7….

MD: Electrocardiographic monitor

FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180221_05

16.04.2018

Schiller AG

Cardiovit AT-102 plus 
Model: 0.075000 
S/N: All

MD: Multichannel electrocardiograph, interpretive, professional

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180403_20

28.03.2018

(Updated16.04.2018)

Alere Technologies AS

Alere Afinion 2 
Model: 1116553, 1116556, 1116557 
S/N: From AF20000001 to AF20002298 
SW-Version: 20.00, 20.01, 20.04, 20.06, 21.00

IVD: Single-channel clinical chemistry analyser IVD, point-of-care

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180326_10

16.03.2018

(Updated16.04.2018)

CIVCO Medical Instruments CO

Infiniti Bracket (Sold as part of CIVCO brand Biopsy Starter Kits and Biopsy Bracket) 
Model: 639-026, 698-009, 698-016, 620-116 
Lot: See FSN

MD: Nonimplantable needle guide, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180308_01

12.04.2018

(Updated13.04.2018)

MRC Holland BV

SALSA MLPA Probemix P060 SMA 
Model: P060-025R 
Lot: B2-1116 
SW-Version: 140721.1958

IVD:

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180403_09

03.04.2018

(Updated13.04.2018)

Synthes GmbH

Sciatic Nerve Retractor 
Model: 03.100.013 and 03.100.014 
Lot: See FSN

MD: Orthopaedic retractor

DE-1 
EN-1 

Vk_20180403_04

29.03.2018

(Updated13.04.2018)

DiaMed GmbH

ID LISS/Coombs ID number 50531 
Model: see FSN 
Lot: see FSN

ID Coombs Anti-IgG ID number 50540 
Model: see FSN 
Lot: see FSN

ID DiaScreen ID number 50571 
Model: see FSN 
Lot: see FSN

ID LISS/Coombs + Enzyme test ID number 50581 
Model: see FSN 
Lot: see FSN

ID DiaClon Type + Screen (ID-Nr.: 50682) 
Model: see FSN 
Lot: see FSN

IVD: Polyspecific antihuman serum

IVD: Polyspecific antihuman serum kit

IVD: Polyspecific antihuman serum

IVD: Polyspecific antihuman serum

IVD: ABO sera

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180327_01

28.03.2018

(Updated13.04.2018)

Getinge – Maquet GmbH

Otesus 
Model: 116001C0, 116001D0 
S/N: 116001C0: 1 until 552, 116001D0: 1 until 34

MD: Table, operating

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

Vk_20180315_02

04.04.2018

(Updated12.04.2018)

Arcoma AB

Intuition 
Model: 0180 
S/N: 1100 – 2036

Precision 
Model: 0072 
S/N: 1001 – 2105

MD: Stationary basic diagnostic x-ray system, digital

MD: Stationary basic diagnostic x-ray system, digital

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

Vk_20180403_16

19.03.2018

(Updated12.04.2018)

ArjoHuntleigh AB

Entroy 
Model: GAB1000-01 and GAB1000-11 
Lot: n/a 
S/N: From 810000957 up to T3387

MD: Mobile patient lifting system, battery-powered

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180312_12

11.04.2018

Siemens Healthcare Diagnostics Products GmbH

Atellica COAG 360 
Model: SMN 10707173 and 100759658 
SW-Version: SW V1.1.1 and below

IVD: Haematology analyser, coagulation

DE-1 
EN-1 

Vk_20180405_06

10.04.2018

Siemens Healthcare GmbH

SOMATOM go.Up and SOMATOM go.Now 
Model: 11061620, 11061610

MD: Full-body CT system

DE-1 
FR-1 

Vk_20180409_08

10.04.2018

Bio-Rad France

Mueller Hinton 2 Agar 
Model: 63824 
Lot: 64153869

IVD: Culture media, antimicrobial susceptibility test

DE-1 
EN-1 

Vk_20180405_12

10.04.2018

GE Healthcare Integrated IT Solutions

Lunar Prodigy 
SW-Version: 9.30

MD: Bone absorptiometric x-ray system, dual-energy

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180403_37

28.03.2018

(Updated10.04.2018)

Stryker Medical Kalamazoo

POWER LOAD 
Model: 6390 
Lot: Units manufactured from 01.01.2016 to 31.12.2016

MD: Ambulance stretcher, manual

DE-1 
EN-1 

Vk_20180319_10

28.03.2018

(Updated09.04.2018)

BioFire Diagnostics, LLC

FilmArray Blood Culture Identification (BCID) Panel 
Model: RFIT-ASY-0127 / RFIT-ASY-0126 
Lot: All manufactured batches

IVD: Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

DE-1 
FR-1 
EN-1 

Vk_20180326_11

27.03.2018

(Updated09.04.2018)

Covidien LLC

LigaSure Exact Dissector, Nano-coated 20.6mm-21c 
Model: LF2019 
Lot: 72550127X, 72770140X, 72770141X, 73000048X

MD: Dissector

DE-1 
FR-1 
EN-1 

Vk_20180326_08

28.03.2018

(Updated09.04.2018)

Hitachi High Technologies Corporation (HHT)

cobas 8000

cobas e 801 module 
S/N: from 1601-01 to 18E6-10

IVD: Multi-modality clinical specimen analysis system IVD

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
FR-1 
EN-1 

Vk_20180323_14

28.03.2018

(Updated09.04.2018)

Dako Denmark A/S

Monoclonal Mouse Anti-Pneumocystis Jiroveci 
Model: M0778 
Lot: 20010445, 20030858, 20042555

Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell 
Model: M0880 
Lot: 20033445, 20040767, 20042272

IVD: Pneumocystis jirovecii antigen IVD, antibody

IVD: Hairy cell leukaemia (HCL) cell marker IVD, antibody

DE-1 
FR-1 
EN-1 

Vk_20180323_12

20.03.2018

(Updated05.04.2018)

Implant Direct Sybron Manufacturing LLC

simply InterActive Implant 
Model: 655010U 
Lot: 68960

MD: Dental implant system

DE-1 
FR-1 
EN-1 

Vk_20180316_09

20.03.2018

(Updated05.04.2018)

Implant Direct Sybron Manufacturing LLC

InterActive Healing Collar 
Model: 6530-15 
Lot: 98151

MD: Dental implant suprastructure, permanent

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180316_08

23.10.2017

(Updated05.04.2018)

Radiometer Basel AG

TCM5 
Model: 393-500 (Flex/Basic) 
S/N: All serial numbers

MD: Transcutaneous blood gas monitoring system

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

Vk_20171010_11

04.04.2018

Iris Diagnostics, a Division of Iris International

iChemVELOCITY Automated Urine Chemistry System 
Model: 800-3530, 800-7167, 800-7719, 800-7720, 800-7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700-7176-001, 700-7177-001 
S/N: All

IVD: Urine analyser IVD, laboratory, automated

EN-1 

Vk_20180403_25

04.04.2018

Siemens Healthcare Diagnostics Inc

CTNI Sample Diluent 
Model: KD692 
S/N: 7BDA34

Multi 1 Sample Diluent (MULTI 1 SDIL) 
Model: KD693 
S/N: 7BDA81

Multi 2 Sample Diluent (MULTI 2 SDIL) 
Model: KD694 
S/N: 7CDA79, 7DDA70

IVD: Buffered sample diluent IVD, automated/semi-automated system

IVD: Buffered sample diluent IVD, automated/semi-automated system

IVD: Buffered sample diluent IVD, automated/semi-automated system

DE-1.0 
FR-1.0 

Vk_20180403_17

04.04.2018

arcomed ag

Volumed µVP7000

MD: Infusion Pumps, Multitherapy, Ambulatory

DE-1.service tech. 
DE-1.user 
FR-1.service tech. 
FR-1.user 
EN-1.service tech. 
EN-1.user 

Vk_20180316_18

03.04.2018

Philips Medical Systems Nederland BV

Allura Xper 
SW-Version: 8.1.25.0, 8.1.25.1, 8.1.25.5, 8.2.25.0, 8.2.25.5, 8.2.27

UNIQ 
SW-Version: 1.0.10, 1.0.10.5

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180403_23

03.04.2018

Kimal Plc

Altius Central Venous Catheter Kit 
Model: See FSN 
Lot: See FSN

MD: Central Venous Catheter Kit

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180327_14

03.04.2018

Medline International France SAS

LDH-Set 
Model: ZGZNE004G 
Lot: 751533, 755464

Craniotomie Set 
Model: ZGZNE005H 
Lot: 755464

Augen-Set 
Model: ZGZEY034C 
Lot: 752319

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

:

:

DE-1.0 

Vk_20180323_09

03.04.2018

Proxomed Medizintechnik GmbH

compass 600 
Model: 1061190

MD: Exercisers, Continuous Passive Motion

DE-1 

Vk_20180319_12

29.03.2018

Mölnlicke Health Care AB

Pack Pied-Main 
Model: 97052006-03 
Lot: 18054178

Pack Rachis 
Model: 97083670-01 
Lot: 18037623

Mölnlycke Procedure trays: Pack cardiaque 
Model: 97010887-15 
Lot: 18057077

MD: Orthopaedic surgical procedure kit, non-medicated, single-use

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

MD: Cardiothoracic surgical procedure kit, non-medicated, single-use

FR-1.0 

Vk_20180322_01

20.03.2018

(Updated29.03.2018)

GE Vingmed Ultrasound AS

TEE Probes 
Model: see FSN

MD: Oesophageal ultrasound imaging system transducer, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180316_17

29.03.2018

Philips Consumer Lifestyle B.V.

AVENT Smart Ear Thermometer and Ear thermometer 
Model: SCH740, DL8740 
S/N: All manufactured devices 
SW-Version: All software versions

MD: Infrared patient thermometer, ear

DE-1 
FR-1 
IT-1 

Vk_20180314_11

28.03.2018

ACUTRONIC Medical Systems AG

fabian Therapy evolution 
Model: 121001 
S/N: between AT10HA-0001 and AT11AC-0254

MD: Neonatal intensive-care ventilator

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180309_11

27.03.2018

Cook Urological, Inc.

StoneBreaker Pneumatic Lithotripter 
Model: Refer to product listing attached 
Lot: All lots of SBL-KIT1, SBA-EC, SBA-EL, SBA-PC, SBA-SC; All unexpired lots of SBC-10, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-02042 
SW-Version: LCK1.6

MD: Hand pneumatic lithotripsy system, urinary

DE-1.0 
FR-1.0 
EN-1.0 

Vk_20180326_12

27.03.2018

Draeger Medical Systems, Inc.

Infinity Acute Care System 
Model: M540 
SW-Version: VG2.2 to VG4.1

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
IT-1 

Vk_20180322_08

20.03.2018

(Updated26.03.2018)

Biotronik AG

Pulsar-18 
Model: 377493, 377476, 377486, 366820, 366816, 366818, 366834, 366843,366828, 377486 
Lot: 12173610, 12174145, 12174146, 12174363, 01180140, 01180366, 01180381, 01180465, 01181147, 01181148, 01182456, 01182837

MD: Multiple peripheral artery stent, bare-metal

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180314_10

26.03.2018

Implant Direct Sybron Manufacturing LLC

Spectra-System/Legacy Guided Surgery Handle Kit 
Model: G-HK 
Lot: 38665

MD: Surgical drill guide, reusable

DE-1 
FR-1 
IT-1 

Vk_20180314_04

26.03.2018

Gambro Dialysatoren GmbH

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

MD: Microbial water purification filter, sterilizable

DE-1.0 

Vk_20180314_01

06.03.2018

(Updated23.03.2018)

F-Care Systems NV

HPR45i 
Lot: All

MD: Probe

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180130_15

20.03.2018

(Updated22.03.2018)

Becton, Dickinson and Company

BD Vacutainer Push Button Blood Collection Set 
Model: 367342 
Lot: see FSN 
S/N: N/A 
SW-Version: N/A

MD: Blood collection/intravenous fluid administration set

DE-1 
EN-1 

Vk_20180320_10

14.03.2018

(Updated22.03.2018)

DiaSys Diagnostic Systems GmbH

HbA1c FS 
Model: 1 3329… 
Lot: see FSN

IVD: Glycosylated/Glycated Haemoglobin

DE-1 
EN-1 

Vk_20180312_14

21.03.2018

IRIS International

iQ200 Series Urine Microscopy Analyzer 
Model: 700-3345, 700-3375, 700-3325, 700-3347, C10683, C10684 
Lot: N/A 
S/N: All 
SW-Version: Not Applicable

IVD: Urine analyser IVD, laboratory, automated

DE-1 
FR-1 
EN-1 

Vk_20180316_25

21.03.2018

bioMérieux

VIDAS FSH 
Model: 30407 / 30407-01 
Lot: 1005888210, 1005888220, 1006006370, 1006080890, 1006094700, 1006214640

IVD: Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)

DE-1 
FR-1 
EN-1 

Vk_20180315_09

21.03.2018

Siemens Healthcare Diagnostics Products GmbH

Atellica COAG 360 
Model: SMN 10707173 and 100759658 
Lot: n/a 
SW-Version: SW V1.1.2 and below

IVD: Haematology analyser, coagulation

DE-1 
EN-1 

Vk_20180314_14

06.03.2018

(Updated21.03.2018)

Eurogine

Intrauterine Device IUD Eurogine 
Lot: See FSN

MD: Intrauterine device, metal-covered

DE-2 
FR-2 
IT-2 
EN-1 
EN-2 

Vk_20180227_10

20.03.2018

Bentley InnoMed GmbH

BeGraft Peripheral Stent Graft System 
Model: 1) BGP5709_1; 2) BGP5709_2 
Lot: 1) 200713, 200675; 2) 200676, 200753, 200635 200546

MD: Stents, Vascular

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180320_02

20.03.2018

GE Healthcare Integrated IT Solutions

GE Centricity PACS IW 
SW-Version: 3.6.0 through 3.7.3.9

MD: Radiology picture archiving and communication system application software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180315_18

20.03.2018

Micrel Medical Devices SA

Rythmic Evolution 
S/N: Less than (and including) 174611237019 
SW-Version: 1.4-A or earlier

MD: Patient-controlled analgesia infusion pump

DE-1 
FR-1 
EN-1 

Vk_20180312_09

31.07.2017

(Updated20.03.2018)

Becton, Dickinson & Company

UVE Specimen collection kit 
Model: 443376

BD MAX Vaginal Panel 
Model: 443710 ; 443712 
S/N: NA 
SW-Version: NA

BD MAX CT/GC 
Model: 442969

BD MAX CT/GC/TV 
Model: 442970

IVD: Urogenital specimen transport medium collection kit

IVD: Multiple vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)

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

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

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

Vk_20170721_03

19.03.2018

William A. Cook Australia Pty Ltd

Vacuum Pump 
Model: K-MAR-5200 
Lot: All lots

MD: General-purpose suction system, line-powered

DE-1 
FR-1 
IT-1 

Vk_20180319_04

19.03.2018

Applimed SA

Cannula needle 
Model: 8001727 
Lot: 17.11.08

MD: Cannulae

FR-1.0 
FR-2.0 
EN-1.0 
EN-2.0 

Vk_20180308_05

19.03.2018

HEINE Optotechnik GmbH & Co. KG

F.O. SP Laryngoskopgriff 
Model: F-001.22.815

MD: Laryngoscope handle, reusable

FR-1 
IT-1 
EN-1 

Vk_20180301_06

19.03.2018

Soluscope SAS

SOLUSCOPE SERIE 3 
Model: 4289, SL-V3-PA 
S/N: 23571, 23575

SOLUSCOPE SERIE 4 PA 
Model: 4102, SL-V4-PA 
S/N: 23191, 23329, 23982, 23983

MD: Flexible endoscope washer

MD: Flexible endoscope washer

DE-1 
FR-1 
IT-1 

Vk_20180221_01

16.03.2018

Mathys AG Bettlach

balanSys ligament tensor 
Model: 71.02.3018 
Lot: 2205708, 2205708N01, 2205708N02 
S/N: N/A

MD: Ligament tensor

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180308_13

16.03.2018

Biomet Orthopaedics, LLC

Persona Partial Knee Spacer Blocks 
Model: 42-5399-035-08, 42-5399-035-09, 42-5399-035-10, 42-5399-035-12, 42-5399-035-14 
Lot: 63552644, 63579568, 63547276, 63579569, 63610265, 63549084, 63579674, 63594433, 63610266. 63549096, 63579676, 63594434, 63610267 63549097, 63579680, 63596547, 63613101

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1.0 
FR-1.0 

Vk_20180306_10

15.02.2018

(Updated16.03.2018)

XO CARE A/S

Dental unit XO 
Model: XO, XO 4, XO FLEX

MD: Dental delivery system

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

Vk_20180130_03

15.03.2018

DiaMed GmbH

IH-1000 
Model: 001000 
Lot: NA 
S/N: NA 
SW-Version: 04.07.02

IVD: Blood grouping system, automated

DE-1 
EN-1 

Vk_20180312_02

07.03.2018

(Updated15.03.2018)

bioMérieux SA

VIDAS LH 
Model: 30406 
Lot: 1005940920, 1006041520, 1006041540, 1006212740, 1006274770

IVD: Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)

DE-1 
FR-1 
EN-1 

Vk_20180305_10

15.03.2018

Micro-Mega SA

B5 shape TS1 n25 4% L31 Classic sterile 
Model: 20953021 
Lot: 062117

MD: Rotary endodontic rasp, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180302_12

13.03.2018

(Updated14.03.2018)

Cryolife, Inc.

On-X Prosthetic heart valve 
Model: ONXA, ONXAE, ONXAC, ONXACE, ONXM, ONXMC, ONXAN 
Lot: all

MD: Cardiac valve prosthesis

DE-1 
FR-1 
EN-1 

Vk_20180312_03

14.03.2018

Philips Medical Systems (Cleveland) Inc.

Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128 
Model: 728317, 728326, 728325, 728321, 728323, 728324, 728306, 728311, 728243, 728244, 728246, 728240, 728235, 728231, 728332, 728256, 728251, 728241 
S/N: Refer to Units Affected List (UAL)

Brilliance CT 6, 10, 16, 16 Power, 40, 64, Big Bore Radiology, Big Bore Oncology, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Flex, MX8000 Dual v. EXP.

MD: Full-body CT system

MD: Full-body CT system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180309_12

14.03.2018

Sofradim Production

Versatex Monofilament Mesh 50 x 50 cm 
Model: VTX5050M

MD: Abdominal hernia surgical mesh, synthetic polymer

FR-1 
EN-1 

Vk_20180308_08

14.03.2018

Randox Laboratories Ltd

Lipase 
Model: Ll3837, Ll7979, Ll8050, Ll8361 
Lot: Not batch specific

IVD: Lipase IVD, kit, enzyme spectrophotometry

FR-1 
IT-1 
EN-1 

Vk_20180306_09

06.03.2018

(Updated14.03.2018)

Hill-Rom, Inc.

PROGRESSA BED SYSTEM 
Model: P7500A 
Lot: Produced between June 8, 2017 to November 1, 2017 
S/N: S159AW9192 through S305AW2321

MD: Basic electric hospital bed

DE-1 
FR-1 
EN-1 

Vk_20180227_18

13.12.2017

(Updated14.03.2018)

DiaSys Diagnostic Systems GmbH

HbA1c IS 
Model: 1 3329 _ _ 
Lot: see FSN

HbA1c FS 
Model: 1 3329 _ _ 
Lot: see FSN

IVD: Glycosylated/Glycated Haemoglobin

IVD: Glycosylated/Glycated Haemoglobin

DE-1 
EN-1 
EN-2 (FS) 
EN-2 (IS) 

Vk_20171206_10

13.03.2018

Nobel Biocare AB

17° Multi-Unit Abutment CC NP 
Model: 36614;36614 
Lot: 12070802 
S/N: N/A 
SW-Version: N/A

MD: Dental implant suprastructure, permanent

DE-1 
FR-1 
IT-1 

Vk_20180313_01

12.03.2018

Bühlmann Laboratories AG

IBDoc, component: CalApp Reader (software) 
Model: LF-IBDOC8 
SW-Version: 1.5.06 (iOS) / 1.5.07 (Android) and earlier

IVD: Other Other Specific Proteins

DE-1 
FR-1 
EN-1 

Vk_20180302_04

20.02.2018

(Updated12.03.2018)

PACIFIC MEDICO

PMH 7000 Series 
Model: 7000000, 7000002, 7000003, 7000007, 517106, 517115, 517146, 517152, 517154, 517158 
Lot: see FSN 
S/N: all

MD: Humidifier, heat/moisture exchange

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180115_03

20.12.2017

(Updated09.03.2018)

Biomet Orthopaedics, LLC

Persona Partial Knee Spacer Blocks 
Model: 42-5399-035-08, 42-5399-035-09, 42-5399-035-10, 42-5399-035-12, 42-5399-035-14 
Lot: 63767442, 63807190, 63769804, 63769805, 63769806, 63767443, 63813674

MD: Orthopaedic prosthesis implantation instrument, reusable

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

Vk_20171213_09

11.09.2017

(Updated09.03.2018)

Beckman Coulter Ireland, Inc.

AQUIOS CL Cytometer 
Model: B30166 
S/N: All

IVD: Flow cytometry analyser IVD, semi-automated

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

Vk_20170831_12

08.03.2018

Zimmer GmbH

Avenir Muller Stem 
Model: Size 4, Lateral: 01.06010.104 & Size 3, Standard: 01.06010.003 
Lot: 2905496; 2904368

MD: Coated hip femur prosthesis, modular

DE-1 

Vk_20180307_12

07.03.2018

Thermo Fisher Scientific Microbiology Basingstoke

Thermo Scientific Oxoid Brilliance Salmonella Agar Base
Model: CM1092B&T 
Lot: 2113980, 2113981, 2114481, 2125747, 2125748

IVD: Salmonella Agar

DE-1 
EN-1 

Vk_20180301_12

01.03.2018

(Updated07.03.2018)

bioMerieux Inc

VITEK 2 Compact 15/30 Systems 
Model: 27415, 27415R, 27530, 27530R, 27630, 27630R 
SW-Version: 8.01 version

IVD: Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

DE-1 
FR-1 
EN-1 

Vk_20180226_03