Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2021 – 31.03.2021

06.04.2021

SERF

Jauges broche F.A.S.T.
Model: 3663165003513, 3663165003520, 3663165003704
Lot: all

MD: Orthopaedic prosthesis implantation instrument, reusable

FR-1

Vk_20210331_03

06.04.2021

Medtronic Inc.

Intellis Recharger
Model: 97755
S/N: all

AIMD: Noninvasive device battery charger

DE-1
FR-1
IT-1

Vk_20210325_12

06.04.2021

Covidien LLC

Surgiwand II Auto Suture Suction and Irrigation Device
Model: 178083, 178093, 178094
Lot: See FSN

MD: Surgical irrigation/aspiration cannula, non-illuminating, single-use

DE-1

Vk_20210322_07

06.04.2021

EUROIMMUN Medizinische Labordiagnostika AG

EUROLINE sample buffer
Lot: D200114AB

IVD: Sample buffer

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

Vk_20210309_16

02.12.2020 

(Updated 06.04.2021)

Hitachi High Technologies Corporation (HHT)

cobas 8000
Model: 05641446001
SW-Version: all

cobas pro
Model: 08464502001
SW-Version: all

cobas c 513
Model: 07649142001
SW-Version: all

IVD: Multi-modality clinical specimen analysis system IVD

IVD: Multi-modality clinical specimen analysis system IVD

IVD: Multi-modality clinical specimen analysis system IVD

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

Vk_20201130_17

01.04.2021

Medline International France SAS

Medline Sterile Procedure Trays
Model: 1417234-3, DGFEY067C, DGFEY101, DGFEY101A, FGREY005C, HGGEN034B, HGGEY041C, HGGEY046A, HGGEY073A, HGGEY094, HGGEY094A, PGSEY071A, QDYN1569-1, ZGZEN017A, ZGZEN028A, ZGZEN028B, ZGZEN045B, ZGZEY002I, ZGZEY020G, ZGZEY036

MD: Syringe

DE-1
FR-1
EN-1

Vk_20210326_10

31.03.2021

Greiner Bio-One GmbH

VACUETTE 9NC Coagulation Tube
Model: see FSN
Lot: see FSN

IVD: Coagulation Tube

DE-1
EN-1

Vk_20210329_06

31.03.2021

CareDx AB

SCORE 6
Lot: N/A
SW-Version: All versions up to and including 6.1.3.0.

IVD: Human genomic analysis interpretive software

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

Vk_20210325_03

31.03.2021

Arcoma AB

Intuition
Model: 0180
Lot: All
S/N: All
SW-Version: All

MD: Stationary basic diagnostic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20210322_26

23.03.2021 

(Updated 31.03.2021)

Ortho Clinical Diagnostics

ORTHO VISION Analyser
Model: 6904579
Lot: Not Applicable
S/N: Not Applicable
SW-Version: 5.13 and below

ORTHO VISION Max Analyzer
Model: 6904578
Lot: Not Applicable
S/N: Not Applicable
SW-Version: 5.13 and below

IVD: Blood group/antibody screening analyser IVD, automated

IVD: Blood group/antibody screening analyser IVD, automated

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

Vk_20210317_25

31.03.2021

Sirona Dental Systems GmbH

INTEGO
Model: 18925871

MD: Dental delivery unit

DE-1
FR-1
IT-1

Vk_20210317_01

16.03.2021 

(Updated 31.03.2021)

Clerio Vision

Extreme H20 59 Xtra
Model: 675506700657, 675506668650
Lot: 0114511565

MD: Contact lens

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

Vk_20210315_02

20.02.2020 

(Updated 31.03.2021)

Siemens Healthcare Diagnostics Inc

Atellica CH Ethyl Alcohol (ETOH)
Model: 11097501
Lot: all

IVD: Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

DE-1
FR-1
EN-1

Vk_20200217_18

30.03.2021

Omnia Srl

Soft Tissue Punch
Model: see FSN
Lot: see FSN

MD: Dental soft-tissue coring punch, single-use

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

Vk_20210326_18

18.03.2021 

(Updated 30.03.2021)

Covidien llc

Kangaroo Enteral Feeding Non-Sterile Pump Sets
Model: See FSN
Lot: See FSN

MD: Enteral feeding noninvasive-component set

DE-1
DE-2
EN-1
EN-2

Vk_20210304_25

29.03.2021

B. Braun Medical AG

proSA Valve and proSA Shuntsystem
Model: FV701T, FX992T
Lot: 20044107, 20047194, 20047839

AIMD: Ventriculo-peritoneal/atrial shunt valve

DE-1

Vk_20210326_01

23.03.2021 

(Updated 29.03.2021)

Roche Molecular Systems Inc.

cobas SARS-CoV-2 & Influenza A/B
Model: 09211101190

cobas Liat Analyzer
Model: 07341920190

IVD: Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

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

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

Vk_20210322_30

18.03.2021 

(Updated 29.03.2021)

bioMerieux Inc

VIDAS CMV IGM 30 TESTS
Model: 30205 & 30205-01
Lot: 1008143230 - Expiry date 04-MAY-2021, 1008182270 - Expiry date 26-MAY-2021, 1008363970 - Expiry date 01-SEP-2021, 1008433580 - Expiry date 15-OCT-2021, 1008143260 - Expiry date 04-MAY-2021, 1008363980 - Expiry date 01-SEP-2021

IVD: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

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

Vk_20210318_11

23.03.2021 

(Updated 26.03.2021)

Beckman Coulter , Inc.

Access Progesterone DE Calibrators
Model: A80773
Lot: 922902
S/N: N/A
SW-Version: N/A

IVD: Progesterone IVD, kit, chemiluminescent immunoassay

FR-1
EN-1

Vk_20210319_22

26.03.2021

Christoph Miethke GmbH & Co. KG

SPRUNG RESERVOIR
Model: FV043T
Lot: 20050906, 20051286

MD: Cerebrospinal fluid reservoir

DE-1

Vk_20210319_18

23.03.2021 

(Updated 26.03.2021)

Hologic, Inc.

Panther Fusion Tube Tray
Model: FAB-15004; (PRD-04000)
Lot: 285762, 285765, 286025, 286026, 289424, 286028, 286852, 287410, 289297, 290057, 290064, 290068, 290409, 291425; (see FSN)

IVD: Tube Tray

DE-1
EN-1

Vk_20210318_12

16.03.2021 

(Updated 26.03.2021)

Medtronic Minimed

MiniMed 780G Insulin Pump
Model: MMT-1885, MMT-1886; Kit 780G models: MMT-1895; MMT-1896
Lot: n.a.
S/N: n.a.
SW-Version: 6.5

MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

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

Vk_20210316_01

25.03.2021

Amplitude S.A.S.

UNI SCORE tibial tray for fixed bearing insert
Model: from 1-0202501 to 1-0202507 and from 1-0205701 to 1-0205807
Lot: see FSN

MD: Uncoated unicondylar knee tibia prosthesis, metallic

DE-1
FR-1
EN-1

Vk_20210317_23

17.02.2021 

(Updated 25.03.2021)

Bovie Medical Corporation

Disposable Bipolar Ablators
Model: 7201, 7201-01, 7203, 7205, 7206, C3390A, C3390NA, C1860NA, C3350A, C3350NA, C2455NA
Lot: All Lots Within Expiration date

MD: Electrosurgical system

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

Vk_20210205_04

24.03.2021

Siemens Healthcare Diagnostics Inc

ADVIA Chemistry Systems
Model: 10315183, 10315769, 10723034
S/N: N/A

IVD: Clinical chemistry analyser

EN-1

Vk_20210322_29

24.03.2021

Beaver Visitec International Ltd

BVI CustomEyes Kits and Malosa Kits
Model: 309628, 305211, 304000, 300328, 301025, 60300139, MMSU0024
Lot: All

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

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

Vk_20210211_06

23.03.2021 

(Updated 23.03.2021)

Siemens Healthcare GmbH, Magnetic Resonance (MR)

ARTIS pheno systems
Model: see FSN
SW-Version: VE20C

Artis icono
Model: see FSN
SW-Version: VE20C

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20210322_12

23.03.2021

Radiometer Medical ApS

PICO70
Model: 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, 956-547; 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, 956-547
Lot: The product expires after 2 years, thus all batches manufactured since March 16, 2019 are affected.
SW-Version: N/A

MD: Arterial blood sampling kit

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

Vk_20210319_02

23.03.2021

TRANSMED MEDIZINTECHNIK GMBH & CO. KG

Transfusionsgerät 200µm
Model: 79.8200.500
Lot: see fsn

MD: Blood transfusion set, non-exchange

DE-1

Vk_20210319_01

23.03.2021

Boston Scientific Corporation

Mamba 135
Model: H7493928713500, H7493928713520
Lot: 26578155, 26578465
S/N: 8714729940241, 8714729940265

Mamba Flex 135
Model: H7493928713540, H7493928713540
Lot: 26578463, 26578470
S/N: 8714729940289, 8714729940289

MD: Vascular microcatheter

MD: Vascular microcatheter

DE-1
FR-1
EN-1

Vk_20210316_12

22.03.2021

BIOSPEEDIA International SARL

BioSpeedia COVID19 Speed-Antigen Test
Model: BSD_0503-25
Lot: 20210220; 20210218; 20210233

IVD: SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid

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

Vk_20210318_09

16.03.2021 

(Updated 22.03.2021)

Abbott

Assurity
Model: PM2152, PM2160, PM2172, PM2240, PM2260, PM2272
S/N: Subset of Assurity and Endurity serialnumbers.

Endurity
Model: PM1152, PM1160, PM1172, PM1240, PM1272
S/N: Subset of Assurity and Endurity serialnumbers.

AIMD: Dual-chamber implantable pacemaker, rate-responsive

AIMD: Single-chamber implantable pacemaker, rate-responsive

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

Vk_20210315_25

16.03.2021 

(Updated 22.03.2021)

Philips Medical Systems

HeartStart FR2+

Philips HeartStart FRx AED

HeartStart HS1

MD: Automatic external defibrillator

MD: Non-rechargeable public automated external defibrillator

MD: Defibrillator, automated, external

DE-1
FR-1
EN-1

Vk_20210312_16

17.03.2021 

(Updated 22.03.2021)

Siemens Healthcare Diagnostics Inc

ADVIA 2120/2120i Hematology System
Model: See FSN
S/N: See FSN
SW-Version: 6.10 and 6.11

IVD: Haematological cell analyser IVD, automated

DE-1
FR-1
EN-1

Vk_20210309_17

22.03.2021

Siemens AG Healthcare

Sensis
Model: see enclosure
S/N: Sensis (VD12A), Sensis Vibe Hemo (VD12A), Sensis Vibe Combo (VD12A)

MD: Cardiac catheterization laboratory computer

EN-1

Vk_20210304_10

09.03.2021 

(Updated 18.03.2021)

DePuy Ireland

MBT CEM KEEL TIB TRAY
Model: See Table 1 in the FSN
Lot: See Table 1 in the FSN

ATTUNE FB TIB BASE SZ
Model: See Table 1 in the FSN
Lot: See Table 1 in the FSN

MD: Uncoated knee tibia prosthesis, metallic

MD: Uncoated knee tibia prosthesis, metallic

DE-1
FR-1
EN-1

Vk_20210226_26

02.03.2021 

(Updated 18.03.2021)

Biosense Webster Inc

CARTO Vizigo Bi-Directional Guiding Sheath
Model: D138501, D138502, D138503
Lot: all

MD: Vascular guide-catheter, single-use

DE-1
FR-1
EN-1

Vk_20210224_19

05.02.2021 

(Updated 18.03.2021)

NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc.

PRECICE System
Model: See Attachment 1

MD: Long bone distraction rod, magnetic

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

Vk_20210202_09

17.03.2021 

(Updated 17.03.2021)

Siemens Healthcare Diagnostics Products GmbH

BCS XP System
Model: 10459330, 10461894, 10470625, 11240019

IVD: Coagulation analyser IVD, laboratory, automated

DE-1
FR-1
EN-1

Vk_20210304_06

17.03.2021

RECIPE Chemicals + Instruments GmbH

ClinCal Whole Blood Calibrator Immunosuppressants
Model: 9933; 9033; 9028
Lot: 9933 Lot 1428; 9033 Lot 1379; 9028 Lot 1457

IVD: Calibrators Multicomponent (CC)

DE-1
EN-1

Vk_20210302_25

09.03.2021 

(Updated 15.03.2021)

HeartWare Inc.

HeartWare Ventricular Assist System - HVAD Pump Implant Kit
Model: Controller (1401, 1403, 1407, 1420), Battery (1650DE), Controller AC Adapter (1425, 1430), Controller DC Adapter (1440), Alarm Adapter (1450), Data Cable (1575)
Lot: n/a
S/N: All
SW-Version: n/a

AIMD: Implantable ventricular circulatory assist system

DE-1
FR-1
EN-1

Vk_20210305_06

09.03.2021 

(Updated 15.03.2021)

Siemens Healthcare GmbH, Diagnostic Imaging, X-Ray-Products

YSIO X.pree
Model: 11107464

MD: Stationary basic diagnostic x-ray system, digital

DE-1
EN-1

Vk_20210304_12

12.03.2021

Caire Diagnostics

Fenom Pro Asthma Monitor
Model: Fenom Pro Nitric Oxide Test, 900-0007 (EU configuration)
Lot: N/A
S/N: All manufactured before 2021-02-23, includes serial numbers between 100107 and 100651
SW-Version: N/A

IVD: Nitrogen monoxide analyser

DE-1
FR-1

Vk_20210305_08

12.03.2021

BD Switzerland Sàrl

Infusion sets for Alaris pump
Model: see FSN
Lot: all

Gravity Infusion Sets and Connectors (various)
Model: see FSN
Lot: all

MD: syringe / volumetric pump infusion sets

MD: Gravity sets, needle-free connectors and Accessories

DE-1
FR-1
IT-1

Vk_20210302_06

03.03.2021 

(Updated 12.03.2021)

RaySearch Laboratories AB

Radiation therapy treatment planning software
Model: RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, 10B, including some of the service packs
S/N: see FSN

MD: Radiation therapy treatment planning system

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

Vk_20210224_12

10.03.2021 

(Updated 11.03.2021)

Weinmann Emergency Medical Technology GmbH + Co. KG

Medumat Transport
Model: WM 28300 und WM 28400

MD: Transport electric ventilator

DE-1
FR-1
IT-1

Vk_20210308_09

09.03.2021 

(Updated 11.03.2021)

UmanDiagnostics AB

NF-light ELISA
Model: 10-7001
Lot: Kit lot 70757
S/N: NA
SW-Version: NA

IVD: Neurofilament protein IVD, kit, enzyme immunoassay (EIA)

DE-1
IT-1
EN-1

Vk_20210303_03

29.12.2020 

(Updated 11.03.2021)

DePuy Ireland

PINNACLE 100 ACET CUP
Model: 121701048, 121701050, 121701052, 121701054, 121701056, 121701058, 121701060, 121701062
Lot: all

PINNACLE 100 HA ACET CUP
Model: 121711048, 121711050, 121711052, 121711054, 121711056
Lot: all

PINN SECTOR HA ACET CUP
Model: 121712048, 121712050, 121712052, 121712054, 121712056
Lot: all

PINN SECTOR ACET CUP
Model: 121722048, 121722050, 121722052, 121722054, 121722056, 121722058, 12172204860, 121722062
Lot: all

PINN 100 W/GRIPTION
Model: 121731048, 121731050, 121731052, 121731054, 121731056, 121731058, 121731060, 121731062
Lot: all

PINN SECTOR W/GRIPTION
Model: 121732048, 121732050, 121732052, 121732054, 121732056, 121732058, 121732060, 121732062, 121732064
Lot: all

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

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

Vk_20201223_11

10.03.2021

Accuray Incorporated (Madison)

CyberKnife
Model: all systems with Standard Treatment Couch

MD: Linear accelerator system

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

Vk_20210308_10

10.03.2021

Biotronik SE & Co. KG

Idova, Iforia, Ilesto, Inventra, Iperia, Itrevia, Ilivia, Inlexa, Intica, Ilivia Neo, Intica Neo ICDs and CRT-Ds
Model: See FSN
S/N: See FSN

AIMD: Defibrillator, implantable

DE-1
FR-1
IT-1

Vk_20210303_21

10.03.2021

Asid Bonz GmbH

Urosid Basic Silicon
Model: 643020
Lot: 1911021973

MD: Catheters, Urinary, Urethral, Drainage, Self-Retained

DE-1
EN-1

Vk_20210302_27

17.02.2021 

(Updated 10.03.2021)

Getinge - Maquet GmbH

MAGNUS Table Column
Model: 118001A0, 118001A1, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0
S/N: 1 - 3402, 1 - 384, 1 - 1028, 1 - 1264, 1 - 401, 3 - 74, 1 - 81, 2 - 1159, 2 - 762

MD: Electrohydraulic operating table base

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

Vk_20210212_02

09.03.2021

Nutricia Medical Devices BV

Flocare Infinity Enteral feeding pump
Model: FLOCARE INFINITY II; Article REF see FSN
S/N: see FSN

Flocare Infinity Enteral feeding pump
Model: FLOCARE INFINITY PLUS; Article REF see FSN
S/N: see FSN

MD: Enteral feeding pump

MD: Enteral feeding pump

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

Vk_20210308_04

09.03.2021

Life Technologies Corporation, a part of Thermo Fisher Scientific

Applied Biosystems COVID-19 Interpretive Software
Model: 100095578 (v1.3), 100095575 (v2.3)
Lot: not applicable
S/N: not applicable
SW-Version: 1.3, 2.3

IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20210303_20

02.03.2021 

(Updated 09.03.2021)

Riverside Medical Packaging Company Ltd

Aseptic Medical Devices
Model: Sterile Transfer Sets & Accessories
Lot: see FSN

MD: Medication transfer set

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

Vk_20210224_23

08.03.2021

Aesculap AG

AESCULAP Univation X System
Model: See FSN
Lot: See FSN

MD: Unicondylar knee insert

DE-1

Vk_20210308_13

24.02.2021 

(Updated 05.03.2021)

Siemens Healthcare GmbH

Artis Q / Q.zen / pheno / icono
Model: see FSN
S/N: Artis Q / Q.zen / pheno / icono systems with a 40 kVA UPS

MD: Stationary angiographic x-ray system, digital

DE-1
EN-1

Vk_20210217_11

22.04.2020 

(Updated 05.03.2021)

HeartWare Inc.

HeartWare Ventricular Assist System - HVAD Pump Implant Kit
Model: 1104, 1125, 1153
S/N: all

AIMD: Implantable ventricular circulatory assist system

DE-1
DE-2
EN-1
EN-2

Vk_20200408_03

04.03.2021

Neuromedex GmbH

MEDILOOPS
Model: 01.2801, 01.2802, 01.2804, 01.2811, 01.2812, 01.2814, 01.2821
Lot: 007248, 007249, 007251, 007252, 007253, 007255, 007256

MD: Tapes

DE-1
FR-1
IT-1

Vk_20210226_10

04.03.2021

Siemens Medical Solutions USA, Inc., Ultrasound

Acuson Sequoia, Diagnostic Ultrasound
Model: 11148775
S/N: See enclosed consignee list.
SW-Version: VA11A

MD: Scanner, ultrasonic, general-purpose

DE-1
IT-1

Vk_20210217_13

04.03.2021

Mercado Medic AB

REAL 9000
S/N: all

REAL 6100
S/N: all

REAL 2000
S/N: all

MD: Assistive ergonomic chair

MD: Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-collapsible

MD: Assistive ergonomic chair

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

Vk_20210211_16

03.03.2021

bioMerieux SA

VIDAS CMV IGM 30 TESTS
Model: 30205
Lot: 1008143230, 1008182270, 1008363970, 1008433580

IVD: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20210226_25

03.03.2021

Caesarea Medical Electronics Limited

Bodyguard 121 Twins
Model: 999-903EN; 999-903ES; 999-903IT
Lot: All
SW-Version: N/A

MD: Multichannel general-purpose infusion pump

EN-1

Vk_20210223_14

02.03.2021

Teleflex Malaysia

Tracflex Plus PDT
Model: see FSN
Lot: see FSN

Tracflex Plus Tracheostomy Tube Set
Model: see FSN
Lot: see FSN

MD: Tracheostomy kit, single-use

MD: Tracheostomy tube, non-reinforced, non-customized, single-use

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

Vk_20210301_15

02.03.2021

Bolton Medical Inc.

RelayPlus
Model: see FSN
Lot: all

Relay 85
Model: see FSN
Lot: all

MD: Descending thoracic aorta endovascular stent-graft

MD: Descending thoracic aorta endovascular stent-graft

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

Vk_20210225_03

02.03.2021

Biomet France

T.E.S.S. (Total Evolutive Shoulder System)
Model: See FSN
Lot: See FSN

MD: Total shoulder prosthesis

DE-1
EN-1

Vk_20210218_15

24.02.2021 

(Updated 02.03.2021)

Physio-Control Corporation

LIFEPAK CR2 defibrillator
Model: CR2-2-000XXX
S/N: all

MD: Non-rechargeable public semi-automated external defibrillator

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

Vk_20210218_01

16.02.2021 

(Updated 02.03.2021)

Olympus Medical Systems Corp.

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

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

OLYMPUS DUODENOVIDEOSCOPE
Model: TJF-Q170V
S/N: all

SINGLE USE DISTAL COVER
Model: MAJ-2315
S/N: all

MD: Flexible video duodenoscope, reusable

MD: Flexible video duodenoscope, reusable

MD: Flexible video duodenoscope, reusable

MD: Flexible video duodenoscope, reusable

DE-1
FR-1
EN-1

Vk_20210211_25

26.11.2020 

(Updated 02.03.2021)

Cardinal Health

Protexis Latex Micro Surgical Gloves
Model: 2D72NT55X, 2D72NT60X, 2D72NT65X, 2D72NT70X, 2D72NT75X , 2D72NT80X, 2D72NT85X, 2D72NT90X
Lot: see FSN

MD: Hevea-latex surgical glove, non-powdered, non-antimicrobial

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

Vk_20201023_03

22.10.2020 

(Updated 02.03.2021)

B.BRAUN MEDICAL

Actreen Hi-Lite Cath Nelaton
Model: 238312
Lot: 18H01E7SWD

Actreen Glys Set Nelaton
Model: 226314A
Lot: 17D28E8SAG

Actreen Mini Cath Nelaton
Model: 228012A
Lot: 18C01E7SWA

Urinocol Pädiatrie Girl geschlossen
Model: 227560A
Lot: 18F07E8SHB

Actreen Lite Cath
Model: 228212A
Lot: 17G27E8SNC

MD: Urine-sampling urethral catheter

MD: Urine-sampling urethral catheter

MD: Urine-sampling urethral catheter

MD: Enteral feeding tube clearing kit

MD: Urine-sampling urethral catheter

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

Vk_20201012_15

22.02.2021 

(Updated 01.03.2021)

CARAG AG

Carag Bioresorbable Septal Occluder (CBSO) System
Model: Carag Bioresorbable Septal Occluder(004-846, 004-847, 004-848); CBSO Extroducer (005-131); CBSO Loading Funnel (006-753); CBSO Position Controls (006-951)
Lot: all
S/N: all

MD: Cardiac occluder

DE-1
EN-1

Vk_20210218_09

01.03.2021

Dent4You AG

DE Single Bond 7th Generation
Model: Dent4You: REF 60019085; Henry Schein: REF 97-92711
Lot: K19851; K16288; K 09209

MD: Dentine bonding agent/set

DE-1

Vk_20210215_19

01.03.2021

Schiller AG

Fred easy
Model: 0A.900000; 3.940060 FEP+ FIRST 3.940063 FEP+ AUTO 3.940066 FEP+ MANUAL
S/N: up to 9000.001164
SW-Version: 1.0 and 1.1

MD: Semi-automated external defibrillator

EN-1

Vk_20210215_12

24.11.2020 

(Updated 01.03.2021)

Karl Storz Endoskope SE und Co. KG

HYSTEROMAT E.A.S.I. SCB
Model: 26340020-1
S/N: all

MD: Surgical irrigation/aspiration system

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

Vk_20201123_08

23.02.2021 

(Updated 26.02.2021)

B. Braun Melsungen AG

Application Kit for subc. Admin.
Model: 900-V4EU01
Lot: 12745200

MD: Needle

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

Vk_20210222_02

25.02.2021

Merit Medical Systems, Inc.

HeartSpan(R) Transseptal Needle
Model: see attached FSN
Lot: see attached FSN

MD: Cardiac transseptal needle, single-use

IT-1
EN-1

Vk_20210204_03

06.10.2020 

(Updated 25.02.2021)

ACUTRONIC Medical Systems AG

fabian +nCPAP evolution
Model: 122001
S/N: All
SW-Version: 5.0.x, 5.1.x

Fabian HFO
Model: 111001, 111001.01, 112001, 113001
S/N: All
SW-Version: 5.0.x, 5.1.x

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

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

Vk_20201001_05

09.02.2021 

(Updated 24.02.2021)

Cardiac Pacemaker Inc

4G LATITUDE MIMIC Cell Adapter
Model: 6227
S/N: All

: Adapter

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

Vk_20210204_13

23.02.2021

BD Medical

Becton Dickinson Syringes
Model: 300328
Lot: N/A
S/N: N/A
SW-Version: N/A

MD: Metered-delivery hypodermic syringe

DE-1
FR-1
EN-1

Vk_20210222_28

23.02.2021

Leica Biosystems Newcastle Ltd

BOND Ready-to-Use Primary Antibody CD19 (BT51E)
Model: PA0843
Lot: 62948, 63694, 63909, 64224, 64432, 64765, 64945, 65317, 65543, 65870, 66328, 67492

Novocastra Liquid Mouse Monoclonal Antibody CD19
Model: CD19-163-L-CE-H, CD19-163-L-CE
Lot: 6063608, 6064866, 6065786, 6066133, 6068609, 6069241, 6069245, 6069811, 6071527, 6073613, 6074342, 6075457, 6079301

IVD: CD19 antibody

IVD: CD19 antibody

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

Vk_20210218_16

23.02.2021

Cordis Corporation

PRECISE PRO RX Carotid Stent System
Model: see FSN
Lot: see FSN
SW-Version: N/A

MD: Bare-metal carotid artery stent

DE-1
FR-1
EN-1

Vk_20210217_01

17.02.2021 

(Updated 22.02.2021)

Abbott

Alinity i HIV Ag/Ab Combo Calibrator
Model: 08P0701, 08P0702 (US only), 08P0709 (China only)
Lot: 21292BE00, 21294BE00 (US only), 21292BE01(China only)

IVD: HIV1/HIV2 antigen/antibody IVD, calibrator

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

Vk_20210211_04

09.02.2021 

(Updated 22.02.2021)

Microbiologics, Inc.

KWIK-STIK 0947P-K-LYFO-DISK_QC Sets&Panels 5193P
Model: Streptococcus pneumoniae ATCC 49619; Catalogue: 0947P , 0947K, 0947L, 5193P
Lot: 0947P = lots 947-126-2 (P) , 947-126-4 (P), 0947K = lot 947-126-3 (K), 0947L = lot 947-126-1 (L), 5193P = lots 5193-10 , 5193-11

IVD: Multiple-type bloodstream pathogen nucleic acid IVD, control

DE-1
FR-1
EN-1

Vk_20210208_09

22.02.2021

Haemonetics Corporation

Blood donor set, quad-pack
Model: WBT434KCE
Lot: All batches manufactured since 2018

Blood transfusion filter
Model: ATSBC1EB, ATSBC1EE, ATSBC1EPSB, ATSBC1ESB, ATSBC1ESE, BPF4ARBL, BPF4BBS, BPF4BWL, BPF4NEOL, LPS2E, LPS2KLE, LRP10BBSL, LRP10BEL, LRP6SC2F, LRP6SCL, PL1BE, PL2VAE, PL3VAE, RC1KLE, RC1VAE, RC1VE, RC2VAE, RC2VE, RN1, RS1VAE
Lot: All batches manufactured since 2018

MD: Blood donor set, quad-pack

MD: Blood transfusion filter

DE-1
FR-1
EN-1

Vk_20210205_02

18.02.2021 

(Updated 22.02.2021)

iMDsoft Ltd

MetaVision Suite
SW-Version: 6.10.x, 6.11.0000-6.11.0081, 6.12.0000-6.12.0005

MD: Information system

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

Vk_20210203_21

17.02.2021 

(Updated 19.02.2021)

Siemens Healthcare GmbH

Sensis, Sensis Vibe Combo, Sensis Vibe Hemo
Model: 10764561, 11007642, 11007641
S/N: Sensis / Sensis Vibe systems with HP Flex Pro-C PC
SW-Version: VD12

MD: Cardiac catheterization laboratory computer

DE-1
FR-1
EN-1

Vk_20210210_22

10.02.2021 

(Updated 18.02.2021)

MAQUET Cardiopulmonary GmbH

Heater-Cooler Unit HCU 40 High Voltage
Model: 70104.4054; 70105.4917; 70104.4054; 70105.4917
S/N: All Serial Numbers below 90442078.

MD: Cardiopulmonary bypass system heat exchanger, reusable

DE-1
FR-1
EN-1

Vk_20210208_01

09.02.2021 

(Updated 17.02.2021)

Medtronic Inc.

Claria MRI / Amplia MRI / Compia MRI / Viva / Brava CRT-Ds
S/N: All devices manufactured using the part number M945899A002

Visia AF / Visia AF MRI / Evera / Evera MRI ICDs
S/N: All devices manufactured using the part number M945899A002

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Single-chamber / Dual-chamber implantable defibrillator

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

Vk_20210203_07

16.02.2021

The Binding Site Group Limited

Diphtheria Toxoid IgG Enzyme Immunoassay Kit
Model: MK014 , MK014.10
Lot: MK014 Lot number: 435281, 483679; MK014.10 Lot number: 469316

IVD: Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

DE-1
EN-1

Vk_20210216_02

16.02.2021

Lohmann & Rauscher GmbH & Co. KG

Ophthalmological Kitpack / Raucoset
Lot: Procedure Packs with the affected B.Braun syringes and needles

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

DE-1
FR-1
IT-1

Vk_20210215_18

16.02.2021

Lohmann & Rauscher GmbH & Co. KG

Ophthalmological Kitpack
Lot: Procedure Packs with the affected BD syringes and needles

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

DE-1
FR-1
IT-1

Vk_20210215_17

16.02.2021

XENIOS AG

DELTASTREAM Systemwagen III MDC
Model: MEDP100321
S/N: SYSMDC-001 - SYSMDC-003, SWIIIMDC002 - SWIIIMDC004, SWIIIMDC006 - SWIIIMDC020, 0001, 0003, 0007, Prototyp1

MD: deltastream trolley

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

Vk_20210215_15

16.02.2021

Miltenyi Biotec GmbH

Blood/tissue storage/culture Container
Model: 200-074-403
Lot: 7200700537

MD: Blood/tissue storage/culture container

DE-1
FR-1
IT-1

Vk_20210211_26

16.02.2021

MicroVention Europe S.A.R.L.

PHIL - Liquid Embolic
Model: See attachment 1
Lot: See attachment 1

MD: Neurovascular embolization plug

DE-1
FR-1
EN-1

Vk_20210211_03

16.02.2021

Weinmann Emergency Medical Technology GmbH + Co. KG

Medumat Transport
Model: WM 28300 and WM 28400
Lot: see List in the FSN

MD: Transport electric ventilator

DE-1
FR-1
IT-1

Vk_20210211_02

16.02.2021

Intersurgical Ltd

CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MA
Model: 1453015
Lot: see FSN

MD: Nebulizing system delivery set, single-use

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

Vk_20201222_18

11.02.2021 

(Updated 15.02.2021)

Steripack SA

Syringes with Sodium Chloride 0.9%
Model: 14363SAL
Lot: Batch numbers up until 1809XXX

MD: Sterile saline flush syringe

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

Vk_20210210_27

11.02.2021 

(Updated 15.02.2021)

CareDx AB

Olerup QTYPE 11
Lot: E044

IVD: Tissue Typing Reagents

DE-1
EN-1

Vk_20210202_02

19.05.2020 

(Updated 12.02.2021)

Siemens Healthcare Diagnostics Inc.

Atellica IM 1600
Model: 11066000
Lot: N/A
S/N: N/A
SW-Version: N/A

Atellica IM 1300
Model: 11066001
Lot: N/A
S/N: N/A
SW-Version: N/A

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

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

Vk_20200512_06

10.02.2021

Microbiologics, Inc.

KWIK-STIK 0318P & Comprehensive QC Sets 5190P
Model: 0318P, 5190P
Lot: 0318P : lot 318-234-4; 5190P : lot 5190-08

IVD: Multiple-type bloodstream pathogen nucleic acid IVD, control

EN-1

Vk_20210208_11

03.02.2021 

(Updated 10.02.2021)

Arkray Factory, Inc.

SPOTCHEM D-00 QR SD-9811
Model: SPOTCHEM D-00 QR SD-9811; 104933
Lot: N/A
S/N: 11906001- 62008015
SW-Version: N/A

SPOTCHEM D-00 SD-9810
Model: SPOTCHEM D-00 SD-9810: 17402
Lot: N/A
S/N: 40803038- 61805020
SW-Version: N/A

IVD: Computer/medical device keyboard

IVD: Computer/medical device keyboard

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

Vk_20210129_12

09.02.2021

Gambro Lundia AB Monitor Division

Prismaflex
Model: see FSN
S/N: All
SW-Version: N/A

MD: Haemodialysis system, institutional

DE-1
FR-1
EN-1

Vk_20210204_18

09.02.2021

BD Medical

BD Syringes and Needles
Model: 309628, 303172, 305211, 304000, 302809

MD: General-purpose syringe, single-use

DE-1
FR-1

Vk_20210203_25

03.02.2021 

(Updated 09.02.2021)

BioFire Diagnostics, LLC

FilmArray Blood Culture Identification (BCID) Panel
Model: RFIT-ASY-0127, RFIT-ASY-0126 (BCID)/ RFIT-ASY-0147 (BCID2)
Lot: All

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

DE-1
FR-1
EN-1

Vk_20210127_20

27.01.2021 

(Updated 09.02.2021)

Maquet Critical Care AB

SoKINOX / SERViNO
Model: 66 94 550; 68 81 700
S/N: EVU-212632

MD: Nitric oxide delivery unit, system-based

DE-1
FR-1
EN-1

Vk_20210120_28

08.02.2021

C-A-T Resources

C-A-T Combat Application Tourniquet
Model: CR-007703-01-000
Lot: See FSN

MD: Tourniquets

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

Vk_20210125_01

03.02.2021

Siemens Healthcare Diagnostics Inc

Dimension Vista High Density Lipoprotein Cholesterol Flex reagent cartridge
Model: SMN 10464340
Lot: 20062BA
S/N: n/a

IVD: High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry

DE-1
FR-1
EN-1

Vk_20210129_13

03.02.2021

Mölnlycke Health Care AB

Mölnlycke Procedure Trays and Single Packed Trocars
Model: see FSN
Lot: see FSN

MD: Surgical procedure kit and single packed Tocars

DE-1
FR-1

Vk_20210125_17

02.02.2021

Thermo Fisher Scientific Oy

Cascadion SM Clinical Analyzer
Model: 99990000
SW-Version: Software 2.0.2 and earlier

IVD: Liquid chromatography/mass spectrometry (LC/MS) analyser IVD, automated

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

Vk_20210126_23

02.02.2021

Rheon Medical SA

eyeWatch implant
Model: eW-M4-01
Lot: M4-20-001, M4-20-002, M4-20-003

MD: Glaucoma shunt

FR-1

Vk_20210120_18

20.01.2021 

(Updated 01.02.2021)

Siemens Healthcare Diagnostics Inc.

Atellica IM and ADVIA Centaur fPSA Calibrator
Model: see FSN
Lot: see FSN

IVD: Free (unbound) prostate specific antigen (fPSA) IVD, calibrator

DE-1
FR-1
EN-1

Vk_20210114_35

20.01.2021 

(Updated 29.01.2021)

Philips Ultrasound Inc.

EPIQ Ultrasound System
Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi)
Lot: NA
SW-Version: 7.0

MD: General-purpose ultrasound imaging system

DE-1
IT-1
EN-1

Vk_20210112_15

28.01.2021

Solutions for tomorrow AB

! M1mobile X-ray
S/N: Article number C3D56 and C36 , Serial number xxxxxx1005 - xxxxxx1243
SW-Version: 1.1.n - 1.2.16

MD: Mobile basic diagnostic x-ray system, digital

DE-1

Vk_20210114_36

27.07.2020 

(Updated 28.01.2021)

Lohmann & Rauscher GmbH & Co. KG

Gauze swabs with x-ray thread in Kitpack, SetPack
Lot: Gauze compresses with X-ray contrast thread in different procedure packs (Kitpack) and as individual products (SetPack) - see FSN and list with additional lot no.

MD: Woven gauze pad, sterile

DE-1-2 KIT
DE-1-2-3 SET
FR-1-2 KIT
FR-1-2-3 SET
IT-1-2 KIT
IT-1-2-3 SET

Vk_20200721_04

10.06.2020 

(Updated 28.01.2021)

Siemens Healthcare Diagnostics Products Limited

PRISCA Prenatal Risk Calculation Software
Model: PRISCA 5 (SMN #10470386, 10484426, 10475998)
Lot: N/A
S/N: N/A
SW-Version: 5.0.0, 5.0.1, 5.0.2, 5.1.0, 5.2.0

IVD: Congenital defect/syndrome risk assessment interpretive software

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

Vk_20200605_19

27.01.2021

Dräger Medical AG & Co.

various: Dräger Neo disposable breathing systems
Model: MP00333, MP00353, MP00363, MP01327, MP01328; NA
Lot: all manufactured since January 2018.

MD: Tubing

DE-1

Vk_20210122_14

26.01.2021

Boston Scientific Corporation

Captivator
Model: see FSN
Lot: see FSN
SW-Version: N/A

Captivator II
Model: see FSN
Lot: see FSN

Captiflex
Model: see FSN
Lot: see FSN

Sensation
Model: see FSN
Lot: see FSN

MD: Mechanical-cutting endoscopic polypectomy snare

MD: Mechanical-cutting endoscopic polypectomy snare

MD: Mechanical-cutting endoscopic polypectomy snare

MD: Mechanical-cutting endoscopic polypectomy snare

DE-1
FR-1
EN-1

Vk_20210121_12

26.01.2021

ConvaTec Limited

Aquacel Extra
Model: 420673
Lot: 0C01702

MD: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

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

Vk_20210120_16

26.01.2021

Baxter Healthcare SA

PrisMax, V2, ROW
Model: PRISMAX MACHINES; 955558
S/N: All serial numbers that were manufactured or received replacement tubing between 1/1/2020 - 01/12/2020

MD: Haemodialysis system, institutional

DE-1
FR-1
EN-1

Vk_20210118_25

19.01.2021 

(Updated 25.01.2021)

Medtronic Inc.

Medtronic Strata II
Model: see FSN
Lot: Lot Number Format: 10 digit number beginning with 02

Delta and CSF-Flow Control Valves
Model: see FSN
Lot: Lot Number Format: 10 digit number beginning with 02

MD: Hydrocephalic shunt

MD: Hydrocephalic shunt

DE-1
FR-1
EN-1

Vk_20210118_05

20.01.2021 

(Updated 25.01.2021)

Leonhard Lang GmbH

Schiller Defibrillationselektrode
Model: 2.155061 FRED EASYPORT
Lot: 191122-0772

MD: Electrodes, Cardiac, External Defibrillator

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

Vk_20210114_23

24.12.2020 

(Updated 22.01.2021)

Bioventus, LLC

EXOGEN Ultrasound Gel
Lot: 190204, 190211, 190213, 190226, 190228, 190230, 190235, 190235T, 190250, 190251, 190252, 90263, 200201, 200203, 200207, 200212, 200212T, 200215, 200218, 200215T, 200227, 200228, 200228T, 200229, 200240, 200240T
S/N: N/A
SW-Version: N/A

MD: Coupling gel, non-sterile

DE-1
FR-1
IT-1

Vk_20201221_07

22.12.2020 

(Updated 22.01.2021)

Likamed GmbH

Selexa
S/N: 14XBL0001 - 19XBL0024

MD: Bed chair

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

Vk_20201216_10

19.01.2021 

(Updated 21.01.2021)

Sartorius Stedim Biotech GmbH

Minisart NML
Model: see FSN
Lot: see FSN

Minisart Ophthalsart
Model: see FSN
Lot: see FSN

MD: Laboratory syringe filter

MD: Laboratory syringe filter

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

Vk_20210115_06

21.01.2021

Terumo BCT, Inc.

Spectra Optia Apheresis System
Model: 61000
S/N: All

MD: Apheresis system

DE-1
FR-1
IT-1

Vk_20210112_16

18.12.2020 

(Updated 21.01.2021)

Mathys Ltd Bettlach

Affinis Inverse glenosphere vitamys
Model: 62.34.0060; 62.34.0061; 62.34.0062
Lot: see FSN
S/N: N/A
SW-Version: N/A

Affinis Inverse glenosphere PE
Model: 60.30.3036; 60.30.3039; 60.30.3042
Lot: see FSN

MD: Artificial shoulder joint

MD: Artificial shoulder joint

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

Vk_20201210_31

28.11.2019 

(Updated 21.01.2021)

Medtronic MiniMed

Medtronic MiniMed 640G Insulin Pump
Model: MMT-1711, MMT-1712

MiniMed 670G Insulin Pump
Model: MMT-1780, MMT-1781, MMT-1782

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

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

Vk_20191125_03

20.01.2021

Philips Ultrasound Inc.

EPIQ Ultrasound System
Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ Cvxi
Lot: NA
SW-Version: NA

MD: General-purpose ultrasound imaging system

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

Vk_20210118_22

20.01.2021

GE Medical Systems LLC

Revolution CT
Model: see FSN

MD: Full-body CT system

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

Vk_20210114_34

19.01.2021 

(Updated 20.01.2021)

Nihon Kohden Corp.

Multiple Patient Receiver
Model: ORG-9100K
SW-Version: All below 05-01

MD: Electrocardiography telemetric monitoring system receiver

DE-1
FR-1
EN-1

Vk_20210114_28

19.01.2021 

(Updated 20.01.2021)

Olympus Medical Systems Corp.

Various EndoTherapy products
Model: see FSN
Lot: see FSN

MD: Endotherapy device

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

Vk_20210111_20

12.01.2021 

(Updated 20.01.2021)

Olympus Medical Systems Corp.

GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500
S/N: all

COLONOVIDEOSCOPE CF-EZ1500DI
S/N: all

COLONOVIDEOSCOPE CF-EZ1500DL
S/N: all

MD: Flexible video gastroduodenoscope

MD: Flexible video gastroduodenoscope

MD: Flexible video gastroduodenoscope

DE-1
EN-1

Vk_20210108_17

19.01.2021

GE Medical Systems (China) Co., Ltd

Vivid
Model: see FSN
Lot: see FSN
SW-Version: with Software Version v204

MD: Cardiovascular ultrasound imaging system

DE-1
FR-1
IT-1

Vk_20210114_45

19.01.2021

Voco GmbH

Rebilda Post System Set
Model: 1771
Lot: 2041515; 2050071

Rebilda Post System Set II
Model: 1792
Lot: 2043338

Rebilda Post Set
Model: 1700
Lot: 2041279

MD: Root canal post, preformed

MD: Root canal post, preformed

MD: Root canal post, preformed

DE-1

Vk_20210114_32

17.11.2020 

(Updated 15.01.2021)

Respironics California, LLC

V60 Ventilator
Model: V60
S/N: See FSN

V60 Plus Ventilator
Model: V60 Plus
S/N: see FSN

V680 Ventilator
S/N: see FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: General-purpose intensive-care ventilator

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

Vk_20201112_10

07.01.2021 

(Updated 14.01.2021)

Invacare Corporation

Invacare Perfecto2 V Oxygen Concentrator
Model: IRC5PO2VAW
S/N: 17HF030338-18IF018523

MD: Mobile/portable oxygen concentrator

DE-1
IT-1
EN-1

Vk_20201229_11

23.12.2020 

(Updated 14.01.2021)

Spacelabs Healthcare Ltd

SENTINEL
Model: 98200 & 98201; software versions 10.0, 10.0.1, 10.0.2, 10.5 , 11.0 and 11.5
SW-Version: software versions 10.0, 10.0.1, 10.0.2, 10.5 , 11.0 and 11.5

MD: Cardiology information system application software

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

Vk_20201215_15

13.01.2021

Draeger Medical Systems, Inc.

Infinity Acute Care System
Model: M540
Lot: M540 Revision Indexes 24-29
SW-Version: VG4.1.1 und tiefer

MD: General-purpose multi-parameter bedside monitor

DE-1
FR-1
IT-1

Vk_20210106_03

22.12.2020 

(Updated 13.01.2021)

MAQUET Cardiopulmonary GmbH

Pediatric Venous Hardshell Cardiotomy Reservoir
Model: 701050111, 701053454, 701049185, 701053455, 701048595, 701051432, 701054166, 701070422; 701050111, 701053454, 701049185, 701053455, 701048595, 701051432, 701054166, 701070422
Lot: see FSN

MD: Cardiotomy reservoir

DE-1
FR-1
EN-1

Vk_20201218_20

12.01.2021

Cook Incorporated

Kwart Retro-Inject Ureteral Stent Set
Model: 003700
Lot: NS13089897

MD: Polymeric ureteral stent

DE-1
EN-1

Vk_20210111_21

15.12.2020 

(Updated 11.01.2021)

Carl Zeiss Meditec AG

IOLMaster 700
Model: 000000-1932-169
S/N: 1154757
SW-Version: 1.90.2.09 and 1.90.8.06

MD: Optical low coherence reflectometry (OLCR) biometer

IT-1
EN-1

Vk_20201208_19

09.12.2020 

(Updated 11.01.2021)

Siemens Healthcare Diagnostics Inc

Atellica IM 1300
SW-Version: V1.23.2 and prior

Atellica CH 930 Analyzer
SW-Version: V1.23.2 and prior

Atellica IM 1600
SW-Version: V1.23.2 and prior

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

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

Vk_20201207_15

29.09.2020 

(Updated 11.01.2021)

Siemens Healthcare Diagnostics Inc

ADVIA Centaur HBsAgII
Model: 10492138
Lot: see FSN
S/N: N/A

IVD: Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

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

Vk_20200925_10

05.02.2020 

(Updated 11.01.2021)

Siemens Healthcare Diagnostics Inc.

Atellica CH 930 Reaction Cuvette Segment
Model: SMN 11099326
Lot: see FSN
S/N: N/A

IVD: Laboratory analyser cuvette IVD, reusable

DE-1
DE-2
DE-3
DE-5
FR-5
EN-1
EN-2
EN-3
EN-4
EN-5

Vk_20200128_08

30.12.2020 

(Updated 08.01.2021)

Qiagen GmbH

QIAstat-Dx Respiratory SARS-CoV-2 Panel
Model: 691214
Lot: 200218
S/N: 402180003 to 402180299

IVD: Other Nucleic Acid Identification - automated

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

Vk_20201230_01

24.12.2020 

(Updated 08.01.2021)

Liko AB

Multirall 200
Model: 3130001S/N: see FSN

MD: Stationary patient lifting system, line-powered

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

Vk_20201215_16

22.12.2020 

(Updated 08.01.2021)

BD

BD 1ml Syringe Luer-Lok
Model: 309628BD Plastipak 1ml Luer
Model: 303172

BD Blunt Fill Needle with Filter 18G x 1 1/2Model: 305211

BD Microlance 3 30G x 1/2 0, 3 x 13mmModel: 302809; 304000

MD: General-purpose syringe, single-useMD: Imaging lesion localization marker, external, reusableMD: Medication transfer needle, filtering

MD: Hypodermic needle, single-use

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

Vk_20201209_19

07.01.2021

WRP Asia Pacific

Dermagrip Ellbogen-Handschuh
Model: small size; D3965-15
Lot: 60301149

MD: Hevea-latex surgical glove, non-powdered, non-antimicrobial

DE-1
FR-1
IT-1

Vk_20210105_08

07.01.2021

GE Medical Systems Israel, Functional Imaging

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

MD: Stationary gamma camera system

EN-1

Vk_2021010