Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2022 – 30.09.2022

23.09.2022

(Updated 30.09.2022)

CareDx AB

Olerup QTYPE 11
Model: 201.701-03/10
Lot: E050; E051; E053; E054; E055; E056; E057; E058; E059; E060; E061

IVD: Hla Antigen Typing

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

Vk_20220923_18

27.09.2022

(Updated 29.09.2022)

Siemens Healthcare Diagnostics Inc.

Lithium (Li) reagents
Model: Atellica CH Lithium (Li) 11097535
Lot: all

Lithium_2 (LITH_2) reagents
Model: Atellica CH Lithium_2 (LITH_2) 11532401
Lot: all

IVD: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy

IVD: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy

DE-1
FR-1
EN-1

Vk_20220921_10

28.09.2022

Synthes GmbH

BME SPEED Implant Kit
Model: SE-1512, SE-0910, SE-1512; SE1512, SE0910, SE1512
Lot: MSE210184; MSE210240; MSE220445
SW-Version: Not applicable

SPEEDSHIFT COMP IMPL KIT
Model: SE-2020-10; SE202010
Lot: MSE210237

MD: Orthopaedic bone staple, non-adjustable

MD: Orthopaedic bone staple, non-adjustable

EN-1

Vk_20220927_18

28.09.2022

Gambro Industries

PRISMAFLEX set
Model: HF20; ST100; ST150; ST60; 109841; 107643; 107636; 107640
Lot: See FSN

MD: Haemofilter

DE-1
FR-1
EN-1

Vk_20220921_13

27.09.2022

Oxoid Deutschland GmbH, Thermo Fisher Scientific

Columbia CAP Agar with Sheep Blood
Model: PB5082A
Lot: 3532554

IVD: Enriched agar culture medium IVD

DE-1
FR-1
EN-1

Vk_20220920_20

12.07.2022

(Updated 27.09.2022)

Hitachi High-Tech Corporation

cobas pure sample supply unit
Model: 09031537001
SW-Version: cobas pure system SW : Version 01-01 and 01-02 (09458115001)

cobas pro sample supply unit
Model: 08464502001
SW-Version: cobas pro INSTALL SW : Version 01-01 to 02-02 (09400915001)

cobas pure e 402 analytical unit
Model: 09031553001
SW-Version: cobas pure system SW : Version 01-01 and 01-02 (09458115001)

cobas e 801 analytical unit
Model: 08454345001
SW-Version: cobas pro INSTALL SW : Version 01-01 to 02-02 (09400915001); Install CD c8000 SW: Version 06-01 to 06-08 (09188584001)

cobas e 801 module
Model: 07682913001
SW-Version: cobas pro INSTALL SW : Version 01-01 to 02-02 (09400915001); Install CD c8000 SW: Version 06-01 to 06-08 (09188584001)

cobas pro SSU
Model: 09205632001
SW-Version: cobas pro INSTALL SW : Version 01-01 to 02-02 (09400915001)

cobas 8000 core unit
Model: 05641446001
SW-Version: Install CD c8000 SW: Version 06-01 to 06-08 (09188584001)

IVD: Integrated / Modular Chemistry / Immunochemistry Instruments – Other

IVD: Multi-modality clinical specimen analysis system IVD

IVD: Integrated / Modular Chemistry / Immunochemistry Instruments – Other

IVD: Automated Immunochemistry Analysers – Moderate To High Routine (throughput > 250 And <= 700 Test/h)

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Integrated / Modular Chemistry / Immunochemistry Instruments – Other

IVD: Integrated / Modular Chemistry / Immunochemistry Instruments – Other

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

Vk_20220711_01

09.03.2021

(Updated 26.09.2022)

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

Vk_20210305_06

23.09.2022

Johnson and Johnson Surgical Vision, Inc.

Veritas Advanced Infusion Packs
Model: VRT-AI
Lot: See FSN

MD: Surgical irrigation/aspiration tubing set

DE-1

Vk_20220916_18

20.09.2022

(Updated 23.09.2022)

Siemens Healthcare Diagnostics Inc.

CLINITEK Novus PRO 12 Urinalysis Cassette
Model: 10634644, 10697848
Lot: all

IVD: Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

DE-1
EN-1

Vk_20220913_19

22.09.2022

Siemens Healthcare GmbH

ARTIS pheno
SW-Version: VE10B

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20220920_04

21.09.2022

Farapulse Inc.

FARAWAVE Pulsed Field Ablation Catheter
Model: 41M401, 41M402; 00810087180096, 00810087180102
Lot: All

FARASTAR Pulsed Field Ablation Generator
Model: 61M401; 00810087180126
Lot: All

MD: Cardiac irreversible electroporation system catheter

MD: Cardiac irreversible electroporation system catheter

DE-1
EN-1

Vk_20220916_13

21.09.2022

Löwenstein Medical SE & Co. KG

elisa 600, elisa 800 und elisa 800 vit

MD: Intensive care ventilator

DE-1
FR-1
IT-1

Vk_20220913_22

14.09.2022

(Updated 20.09.2022)

Roche Molecular Systems, Inc.

cobas 5800 Instrument
Model: 08707464001
SW-Version: N/A

IVD: Nucleic Acid Testing Integreted Extration /amplification /detection Systems

DE-1
FR-1
EN-1

Vk_20220913_23

08.12.2020

(Updated 19.09.2022)

Siemens Healthcare Diagnostics Inc

ADVIA GGT reagent
Model: 10309495 (20ml); 10316298 (70ml)
Lot: see FSN

Atellica GGT reagent
Model: 11097597
Lot: see FSN

IVD: Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry

IVD: Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry

DE-1_ADVIA
DE-1_Atellica
DE-2_ADVIA
DE-2_Atellica
FR-1_Atellica
FR-2_ADIVA
FR-2_Atellica
EN-2_ADVIA
EN-2_Atellica

Vk_20201130_13

16.09.2022

Gelita Medical GmbH

GELITA TUFT-IT
Model: GF-7365; GF-7336
Lot: All lots with shelf-life

MD: Gelatin haemostatic agent

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

Vk_20220912_09

31.08.2022

(Updated 16.09.2022)

MicroPort CRM S.r.l.

XFINE
Model: XFine JX24D MRI, XFine JX25D MRI, XFine TX25D MRI, XFine TX26D MRI; TLD056C, TLD057C, TLD054C, TLD055C
S/N: See FSN

AIMD: Endocardial pacing lead

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

Vk_20220830_01

15.09.2022

Abbott Vascular

MitraClip G4 Clip Delivery System, MitraClip NTR/XTR Clip Delivery System, TriClip NT/XT Clip Delivery System, and TriClip G4 Clip Delivery System
Model: All model numbers
Lot: All lots
S/N: N/A
SW-Version: N/A

MD: Heart valve clip

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

Vk_20220907_03

30.08.2022

(Updated 15.09.2022)

Philips Medical Systems (Cleveland), Inc.

Pinnacle3 Radiation Therapy Planning System
Model: 870231, 870237
SW-Version: 16.0.4, 16.4.2, 16.4.3, 16.4.6, 18.0.1

MD: Radiation therapy software

DE-1
FR-1
EN-1

Vk_20220825_04

26.08.2022

(Updated 15.09.2022)

Leica Microsystems (Schweiz) AG

Arveo
Model: 10448999
S/N: manufactured between July 01st, 2021 and June 8th, 2022
SW-Version: not applicable

ARveo 8
Model: 10449063
S/N: manufactured between July 01st, 2021 and June 8th, 2022

Leica M530 OHX
Model: 10448737, 10448700, 10448704
S/N: manufactured between July 01st, 2021 and June 8th, 2022

PROvido
Model: 10448976, 10448950
S/N: manufactured between July 01st, 2021 and June 8th, 2022

MD: General-purpose surgical microscope

MD: Operative Microscopes

MD: Neurosurgical microscope

MD: General-purpose surgical microscope

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

Vk_20220819_27

23.11.2021

(Updated 15.09.2022)

Medtronic Navigation Inc.

Synergy Cranial, StealthStation Cranial
Model: 9733763, 9735585
Lot: –
S/N: All
SW-Version: 2.2.8; 3.1.1; 3.1.2; 3.1.3

MD: Neurological stereotactic surgery system

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

Vk_20211117_28

14.09.2022

SenTec AG

NeoContactAgent
Model: 1ST232-100; 1ST230-100
Lot: see FSN

MD: Impedance pneumograph monitor

DE-1

Vk_20220907_19

17.08.2022

(Updated 14.09.2022)

Respironics, Inc

Amara View
Model: See FSN

DreamWisp
Model: See FSN

DreamWear
Model: See FSN

Wisp
Model: See FSN

Therapy Mask 3100
Model: See FSN

MD: CPAP/BPAP face mask, reusable

MD: CPAP/BPAP nasal mask, reusable

MD: CPAP/BPAP face mask, reusable

MD: CPAP/BPAP nasal mask, reusable

MD: CPAP/BPAP nasal mask, reusable

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

Vk_20220817_09

13.09.2022

Datex-Ohmeda Inc.

Aisys CS2
Model: 1011-9050-000
S/N: See FSN

Avance CS2
Model: 1009-9050-000
S/N: See FSN

Avance CS2 Pro
Model: 1009-9050-000
S/N: See FSN

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

DE-1

Vk_20220907_17

06.09.2022

(Updated 12.09.2022)

CareDx AB

Olerup QTYPE 11
Model: see FSN
Lot: see FSN

IVD: HLA class I & II antigen tissue typing IVD, kit, multiplex

DE-1
EN-1

Vk_20220901_24

07.09.2022

BS Medical Tech Industry Sarl

Flocare® Safety+ GT /-Suction
Model: CH 12, CH 14; 673803, 673802, 673801
Lot: See FSN

Flocare DirectPEG
Model: CH 12, CH 14; 656893, 656707
Lot: See FSN

MD: Gastro-jejunostomy, Tubes And Sets

MD: Gastro-jejunostomy, Tubes And Sets

DE-1
FR-1
IT-1

Vk_20220905_05

06.09.2022

Ortho Clinical Diagnostics

VITROS Immunodiagnostic Products HIV Combo Calibrators
Model: 6842780
Lot: see FSN

VITROS Immunodiagnostic Products HIV Combo Reagent Pack
Model: 6842779
Lot: see FSN

IVD: HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

IVD: HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20220905_04

06.09.2022

Datex-Ohmeda Inc.

Avance CS2
Model: See FSN

Avance CS2 Pro
Model: See FSN

Aisys CS2
Model: See FSN

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

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

Vk_20220901_16

31.08.2022

(Updated 01.09.2022)

Medtronic Inc.

Prevail Paclitaxel-coated PTCA Balloon Catheter
Model: See Appendix A, FSN
Lot: See Appendix A, FSN

MD: Coronary angioplasty balloon catheter, drug-coated

DE-1
FR-1
EN-1

Vk_20220830_02

01.09.2022

Spiggle & Theis Medizintechnik GmbH

ENT single-use suction tubes
Model: 3010025, 3010030, 3010040
Lot: 20181130

MD: Suction Tips, General-Purpose

DE-1
EN-1

Vk_20220816_12

25.08.2022

(Updated 31.08.2022)

Bonebridge AG

TAMINA
Model: all
Lot: all

MD: Bone Fixation Plates

DE-1
FR-1
EN-1

Vk_20220822_02

23.08.2022

(Updated 31.08.2022)

Mallinckrodt Pharmaceuticals Ireland Limited

THERAKOS CELLEX Photopheresis System
Model: CLXECP
Lot: K257

MD: Photopheresis system blood set

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

Vk_20220819_12

31.08.2022

Medline International France SAS

Sterile Surgical Gowns
Model: NS-S3510P; NS-S3513P; NS-S3540P; NS-S3581P; S3500P
Lot: see FSN
SW-Version: N/A

MD: Surgical gown, single-use

DE-1
FR-1

Vk_20220817_16

30.08.2022

Siemens Healthcare Diagnostics Products GmbH

N Antiserum to Human IgG
Model: see FSN
Lot: see FSN

IVD: Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

DE-1
FR-1
EN-1

Vk_20220824_01

29.08.2022

(Updated 30.08.2022)

MELAG Medizintechnik GmbH & Co. KG

Careclave 618
Model: ME10618
S/N: up to 20226181185

MD: Cleaning, Disinfection And Sterilisation Instruments

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

Vk_20220822_22

24.08.2022

(Updated 30.08.2022)

bioMérieux SA

VIDAS 3 SOFTWARE
Model: 423694
SW-Version: 1.4.0 and 1.4.1

IVD: Fluorescent immunoassay analyser IVD, laboratory, automated

DE-1
FR-1
EN-1

Vk_20220819_20

24.08.2022

(Updated 29.08.2022)

Siemens Healthcare Diagnostics Inc.

Dimension Magnesium (MG) Flex reagent cartridge
Model: 10444963/DF57
Lot: FA2350, FA2356, GA2363, FA3019

IVD: Magnesium (Mg2+) IVD, kit, spectrophotometry

DE-1
FR-1
EN-1

Vk_20220822_01

26.08.2022

Omnyx, LLC

Dynamyx Digital Pathology Software
SW-Version: 2.x.x

IVD: Pathology information system application software

DE-1

Vk_20220822_17

26.08.2022

Cook Incorporated

Double Flexible Tipped Wire Guide
Model: TDOC-35-145-0-3
Lot: 14793053

Fixed Core Wire Guide (Safe-T-J® Curved)
Model: TSCF-35-145-3; TSCF-35-80-3
Lot: 14831157, 14826198, 14831162, 14826199, 14831159; 14814971

Fixed Core Wire Guide (Straight)
Model: TSF-35-145
Lot: 14833117, 14809680, 14821850, 14827356, 14833110, 14827353, 14821851, 14821849, 14821854

Cope Mandril Wire Guide (Nitinol)
Model: PMG-18SP-60-COPE-NT
Lot: 14816750, 14816754

Vinyl Connecting Tube
Model: CTU14.0-30; CTU14.0-40-ST
Lot: NS14831012, NS14816264, NS14816265; NS14818298

Roadrunner Hydrophilic PC Wire Guide
Model: RPC-035145-0-5; RPC-035145-5; RPC-038145-0-5
Lot: 14769270X, 14828629, 14818489, 14802181, 14818488, 14816224; 14770872; 14804972, 14809971

MD: Peripheral vascular guidewire, manual

MD: Peripheral vascular guidewire, manual

MD: Peripheral vascular guidewire, manual

MD: Peripheral vascular guidewire, manual

MD: Low-pressure tubing connector, single-use, sterile

MD: Peripheral vascular guidewire, manual

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

Vk_20220818_11

26.08.2022

Haag-Streit AG

Connector Box of Imaging Module IM 910
Model: CB01; 1023640
Lot: 014952008; 014919686; 014828063; 014828063
S/N: 111; 112; 149; 150
SW-Version: N/A

MD: Ophtalmology Assessments And Diagnosis Instruments

DE-1
FR-1

Vk_20220809_06

12.08.2022

(Updated 26.08.2022)

CooperVision Manufacturing Limited

All in one light (and branded variants)
Model: CLC001
Lot: 162046

MD: Multi-purpose soft/rigid contact lens solution

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

Vk_20220804_14

25.08.2022

Becton Dickinson GmbH

Sabouraud Agar with Gentamycin and Chloramphenicol
Model: 254041; 254096
Lot: 2150314; 2172776

Sabouraud Agar with Chloramphenicol
Model: 254091
Lot: 2159395; 2172774

Sabouraud GC Agar / BBL CHROMagar Candida Medium (Biplate)
Model: 254515
Lot: 2152631

IVD: Differential/selective agar culture medium IVD

IVD: Differential/selective agar culture medium IVD

IVD: Multiple formulation agar culture medium IVD

DE-1
FR-1
EN-1

Vk_20220822_05

01.07.2022

(Updated 25.08.2022)

Integra LifeSciences Corp

CereLink ICP Monitor
Model: 826820
S/N: All serial numbers ranging from CLK2111003 to CLK2215542

MD: Intracranial pressure monitor

DE-2
DE-4
FR-2
FR-4
IT-2
IT-4
EN-2
EN-3 Extension-1
EN-4

Vk_20220628_01

24.08.2022

Planer Limited

Humidifier Bottle and Syringe filter kit for BT37
Model: AY102295, AY200246
Lot: see FSN

MD: Non-heated respiratory humidifier

DE-1
EN-1

Vk_20220815_17

23.08.2022

B. Braun Melsungen AG

SpaceStation with SpaceCom
Model: 8713142
SW-Version: 011L0000L81 and earlier

SpaceCom
Model: 8713160
SW-Version: 011L0000L81 and earlier

Battery-Pack SP (Li-Ion) incl. pin and WiFi
Model: 8713182A
SW-Version: 027L0000L81 and earlier

Data module compactplus
Model: 8717160
SW-Version: I0050A0010

MD: Electric infusion pump administration set, single-use

MD: Electric infusion pump administration set, single-use

MD: Electric infusion pump administration set, single-use

MD: Electric infusion pump administration set, single-use

DE-1
FR-1
IT-1

Vk_20220819_26

23.08.2022

Merit Medical Systems, Inc.

CorVocet Biopsy System
Model: See FSN
Lot: See FSN

MD: Soft-tissue biopsy procedure kit, non-medicated

DE-1
FR-1
IT-1

Vk_20220818_01

16.08.2022

(Updated 23.08.2022)

Biomedical Data Solutions Limited

Ortho Connect
Model: 3.0; 6904413; 6904414; 6904415; 6913355; 6904410; 6904411; 6904412; 6993333; 6993332

IVD: Laboratory instrument/analyser application software IVD

FR-1
EN-1

Vk_20220810_15

22.08.2022

FUJIFILM medwork GmbH

CrossSnare
Model: POL1-X1-15-23-220-OL, POL1-X1-10-23-220-OL; 502308 and 502309
Lot: 22252483, 22252574, 22252721

MD: Snare, endoscopic

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

Vk_20220805_01

28.06.2022

(Updated 22.08.2022)

Medtronic Inc.

Cobalt XT
Model: DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4, DTPA2D4, DTPA2D1, DTPA2QQ, DTPA2Q1
S/N: All

Cobalt
Model: DVPB3D1, DVPB3D4, DDPB3D1, DDPB3D4, DTPB2D4, DTPB2D1, DTPB2QQ, DTPB2Q1
S/N: All

Crome
Model: DVPC3D1, DVPC3D4, DDPC3D1, DDPC3D4, DTPC2D4, DTPC2D1, DTPC2QQ, DTPC2Q1
S/N: All

AIMD: Dual-chamber implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

DE-1-Notification
DE-1-Retrieval
DE-2
FR-1-Notification
FR-1-Retrieval
FR-2
IT-1-Notification
IT-1-Retrieval
IT-2
EN-1-Notification
EN-1-Retrieval
EN-2

Vk_20220624_01

25.03.2022

(Updated 22.08.2022)

Instrumentation Laboratory Co.

ACL TOP
Model: 00000280060, 00000280065, 00000280040, 00000280045, 00000280097
S/N: all

IVD: Coagulation analyser IVD, laboratory, automated

DE-1
DE-2

Vk_20220318_05

02.08.2022

(Updated 19.08.2022)

DiaSys Diagnostic Systems GmbH

LDL-c direct FS
Model: 1 4131 99 10 921

IVD: Low Density Lipoprotein Cholesterol including sd-LDL

DE-1 – Distributor
DE-1 – End customers
EN-1 – Distributor

Vk_20220729_20

18.08.2022

bioMérieux SA

VIDAS TB-IGRA
Model: 423111
Lot: 1008446570, 1008800300, 1008800310, 1008454760, 1008779880, 1008949330, 1009196920, 1009233340, 1009376590, 1009376580, 1009371190
S/N: N/A
SW-Version: N/A

IVD: Interferon gamma release IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20220812_15

16.08.2022

(Updated 17.08.2022)

Nutricia Medical Devices BV

Flocare Infinity Enteral feeding pump
Model: II; 35676, 35677
S/N: All
SW-Version: All

MD: Enteral feeding pump

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

Vk_20220815_08

17.08.2022

Technomed Europe

Disposable Subdermal Needle Electrode, Pt/Ir
Model: TE/S46-638; TE/S46-638/01
Lot: 046241, 044220, 045077, 045443, 045831, 046574, 047126, 047843, 048428, 049285, 050426, 051402, 052709

MD: Subdermal needle electrode

DE-1
FR-1
IT-1

Vk_20220805_13

16.08.2022

Löwenstein Medical Technology GmbH + Co. KG

LUISA
S/N: 50013752 – 50017318, and all devices updated by customers
SW-Version: 1.5.0030

MD: Neonatal/adult intensive-care ventilator

DE-1
EN-1

Vk_20220815_20

16.08.2022

Datex-Ohmeda Inc.

field replacement batteries for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Model: distributed on or after April 1, 2019

Avance CS2
Model: manufactured on or after April 1, 2019

Avance CS2 Pro
Model: manufactured on or after April 1, 2019

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

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

Vk_20220812_01

16.08.2022

Siemens Healthcare GmbH

Artis Q / Q.zen / pheno / icono
S/N: Artis Q / Q.zen / pheno / icono systems in combination with a specific lot of X-ray tubes

MD: Stationary angiographic x-ray system, digital

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

Vk_20220811_10

16.08.2022

Drägerwerk AG & Co. KGaA

GCS 1200 Control
Model: G42156
Lot: see FSN

MD: Medical Gas/Vacuum Systems

DE-1

Vk_20220810_14

16.08.2022

BECTON DICKINSON INFUSION THERAPY AB

BD Venflon Pro Safety I.V. Cannula
Model: 393222, 393224, 393226, 393227, 393228, 393229, 393230, 393282
Lot: See FSN

MD: Peripheral intravenous cannula

DE-1
FR-1
EN-1

Vk_20220518_02

21.09.2021

(Updated 12.08.2022)

Exactech Inc.

Exactech Knee and Ankle UHMWPE inserts
Model: See FSN
S/N: See FSN

MD: Logic CRC Insert; Logic CR Insert; Logic PS Tibia, Modinsert; Ankle Prim Mobile Liner

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

Vk_20210906_17

10.08.2022

Cordis Cashel

Cordis S.M.A.R.T. Flex Vascular Stent System
Model: Refer to Table 1 in FSN letter.
Lot: Refer to Table 1 in FSN letter.

MD: Peripheral artery stent, bare-metal

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

Vk_20220729_09

09.08.2022

Beckman Coulter Ireland, Inc.

iChem VELOCITY Urine Chemistry Strips
Model: 800-7204
Lot: 7204612M

IVD: Urine rapid test device, multiple-constituent

DE-1
FR-1
EN-1

Vk_20220805_18

09.08.2022

Intuitive Surgical, Inc

da Vinci EndoWrist Clip Appliers
Model: 420230, 420327, 420003, 470230, 470327, 470401
Lot: All

MD: Robotic surgical ligation clip applier

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

Vk_20220805_12

09.08.2022

IMMUCOR Medizinische Diagnostik GmbH

Automated immuClone Anti-K (Kell) IgM
Model: 0066088
Lot: 922040 (exp. Date 2022-11-30), 922041 (exp. Date 2023-04-30), 922042 (exp. Date 2023-10-31), 922043 (exp. Date 2024-04-30)

IVD: Anti-K (KEL001) red blood cell grouping IVD, antibody

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

Vk_20220805_03

09.08.2022

GE Medical Systems Information Technologies, Inc.

Carescape Central Station

MD: Centralized patient monitor

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

Vk_20220804_11

12.07.2022

(Updated 09.08.2022)

Smiths Medical ASD Inc

H-2 Level 1 – Pressure Chamber
Model: 7204012, 7204016, 7204017, 7204018, 7204019, 7204020, 7204030, 7204034, 7204036, 7204064, 7204065, 7204068, 7204071, 7204074, CON-7204012, H-2JP, 7802722-DE, 7802722-EN, 7203019, 7203020
Lot: 44000173 to 44007145 20030142, 20040790, 20051157, 20051158, S10001740, S10001741, S10002495, S10002589, S10006978, S10007279, S10008826, S109A02601, S109A03349, S109A03352, S109A03404, S109A05072, S109A06524, S109A06731

MD: Intravenous pressure infusor, automated

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

Vk_20220707_13

02.08.2022

(Updated 08.08.2022)

Ortho-Clinical Diagnostics Inc. Rochester

VITROS XT7600
Model: 6844461
SW-Version: Version 3.7.2 and below

VITROS XT3400
Model: 6844458
SW-Version: Version 3.7.2 and below

IVD: Multiple clinical chemistry analyser IVD, laboratory, automated

IVD: Dry clinical chemistry analyser IVD, automated

DE-1
EN-1

Vk_20220726_13

08.08.2022

Olympus Medical Systems Corp.

OLYMPUS DUODENOVIDEOSCOPE
Model: TJF-Q170V & TJF-Q190V & TJF-Q290V Duodenovideoscopes; N5992960, N5992950, N5425051, N5993260, N5993250, N6000360
S/N: All

MD: Flexible video duodenoscope, reusable

DE-1
FR-1
EN-1

Vk_20211214_01

08.08.2022

Datex-Ohmeda Inc.

Carestation 750, Carestation 750c

MD: Anaesthesia workstation, general-purpose

DE-1
FR-1
EN-1

Vk_20211210_16

08.08.2022

Philips Medical Systems Nederland B.V

BV Pulsera und BV Endura (Chirurgie Bildverstärker)
Model: BV Endura – 718075 , BV Pulsera – 718095
S/N: See FSN

Veradius
Model: Veradius Unity – 718132
S/N: See FSN

BV Vectra
Model: 718400
S/N: See FSN

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

MD: C-arm, diagnostic x-ray unit, mobile

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

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

Vk_20211208_28

05.08.2022

Barco

Barco
Model: MNA-240 ENC DP, MNA-240 ENC DP MQ, MNA-240 ENC DP OL, MNA-240 ENC DP KS

MD: Image display monitor, colour

DE-1
DE-1-Karl Storz
DE-2
FR-1
FR-1-Karl Storz
FR-2
IT-1
IT-1-Karl Storz
IT-2

Vk_20220725_21

15.03.2022

(Updated 04.08.2022)

DNA Genotek Inc

ORAcollect DNA
Model: OCR-100
Lot: Multiple

ORAcollect Dx/ ORAcollect RNA
Model: OCD-100; OCD-100A; ORE-100
Lot: Multiple

MD: Oral/respiratory tract specimen container IVD, additive/medium

MD: Oral/respiratory tract specimen container IVD, additive/medium

DE-1_ORAcollect DNA
DE-2_ORAcollect DNA
FR-1_ORAcollect DNA
FR-2_ORAcollect DNA
IT-1_ORAcollect DNA
IT-2_ORAcollect DNA
EN-1_ORAcollect DNA
EN-1_ORAcollect Dx_RNA
EN-2_ORAcollect DNA

Vk_20220315_06

03.08.2022

Medtronic Inc.

Vanta LT Clinician Programmer Application
Model: A71200
S/N: All
SW-Version: 2.0.2455

AIMD: Multiple active implantable device programmer

DE-1
FR-1
EN-1

Vk_20220729_03

03.08.2022

Medtronic Inc.

Vanta LT Clinician Programmer Application
Model: A71200
S/N: All
SW-Version: 2.0.2455

AIMD: Multiple active implantable device programmer

DE-1
FR-1
EN-1

Vk_20220729_02

26.07.2022

(Updated 03.08.2022)

Alere San Diego, Inc

Cholestech LDX Cassette
Model: 10-987, 10-989 , 10-990, 10-991, 99021, 14-531

IVD: Lipid peroxide IVD, reagent

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

Vk_20220721_13

03.08.2022

Metrax GmbH

PRIMEDIC HeartSave
Model: 73943100000 – 73943100367, 73944100000 – 73944100594, 73945100000- 73945100928, 73946100000 – 73946100569

MD: Defibrillators, External, Automated

DE-1
FR-1
EN-1

Vk_20220712_13

02.08.2022

DiaSys Diagnostic Systems GmbH

NEFA FS
Model: 1 5781
Lot: 31731

IVD: Non Esterified Fatty Acids

DE-1
EN-1

Vk_20220729_21

02.08.2022

GE Healthcare IITS USA Corporation

Centricity Universal Viewer
S/N: Software Versions, 6.0 SP9 through 6.0 SP10.4, 7.0 SP0 through SP0.0.4.9, 7.0 SP0.0.5, 7.0 SP0.1.0, 7.0 SP1, 8.0 SPB through SP0.1.1
SW-Version: Refer to field “Serial numbers)

MD: Medical image management system

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

Vk_20220728_01

29.07.2022

Fresenius Kabi AG

COMPOFLEX 1F 63 ml CPDA1 – PDS – V
Model: PS11150
Lot: Within shelf live

COMPOSTOP FLEX 2F PLT PROC. LEUKO RED
Model: PD51600
Lot: Within shelf live

COMPOFLEX 1F 63CPDA-1 LUER-M
Model: PS111EA
Lot: Within shelf live

CompoStop Flex 3F T&B – 7-PLT pool
Model: PT52600
Lot: Within shelf live

COMPOFLEX 1F EMPTY 600 PD-V
Model: T2131
Lot: Within shelf live

MD: Blood donor set, single-pack

MD: Blood donor set, double-pack

MD: Blood donor set, double-pack

MD: Blood donor set, triple-pack

MD: Blood donor set, single-pack

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

Vk_20220722_15

19.07.2022

(Updated 28.07.2022)

OCULUS Optikgeräte GmbH

Pentacam AXL
Model: 70100
S/N: Software Version 1.26r26 & 1.26r27
SW-Version: 1.26r26 & 1.26r27

Pentacam HR
Model: 70900
S/N: Software Version 1.26r26 & 1.26r27
SW-Version: 1.26r26 & 1.26r27

Pentacam AXL Wave
Model: 70020
S/N: Software Version 1.26r26 & 1.26r27
SW-Version: 1.26r26 & 1.26r27

MD: Anterior segment analysis device

MD: Corneal topography system

MD: Corneal topography system

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

Vk_20220715_20

27.07.2022

MAQUET Cardiopulmonary GmbH

HLS Set Advanced 7.0
Model: 701069073; 701069083
Lot: See FSN

HLS Set Advanced 5.0
Model: 701069076
Lot: See FSN

MD: Cardiopulmonary bypass system tubing set

MD: Cardiopulmonary bypass system tubing set

DE-1
FR-1
EN-1

Vk_20220722_14

27.07.2022

Cook Incorporated

Roadrunner PC Hydrophilic Wire Guide
Model: see FSN
Lot: see FSN

Roadrunner UniGlide Hydrophilic Wire Guide
Model: see FSN
Lot: see FSN

MD: Peripheral vascular guidewire, manual

MD: Peripheral vascular guidewire, manual

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

Vk_20220720_09

21.03.2022

(Updated 27.07.2022)

Gelita Medical GmbH

GELITA-SPON RAPID3
Model: GR-010; GR-310; GR-610; GR-005; GR-007
Lot: All

GELITA-SPON Standard
Model: GS-010 DP; GS-015; GS-030; GS-060; GS-110; GS-003; GS-325; GS-004; GS-610; GS-950; GS-010 SP; GS-210; GS-310; GS-002
Lot: All

GELITA-SPON POWDER
Model: GS-265
Lot: All

GELITA ENT X-PASTE
Model: GE-2165
Lot: All

GELITA ENT X-DENSE
Model: GE-6385; GE-6311
Lot: All

GELITA ENT X-BLOD
Model: GE-8382; GE-8385
Lot: All

GELITA ENT X-PAND
Model: GE-6382
Lot: All

MD: Gelatin haemostatic agent

MD: Gelatin haemostatic agent

MD: Gelatin haemostatic agent

MD: Gelatin haemostatic agent

MD: Gelatin haemostatic agent

MD: Gelatin haemostatic agent

MD: Gelatin haemostatic agent

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

Vk_20220314_02

26.07.2022

GE Medical Systems, LLC

SIGNA Premier
Model: 00840682135269, 00195278010797

MD: Full-body MRI system, superconducting magnet

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

Vk_20220725_17

26.07.2022

Thermo Fisher Scientific Microbiology Basingstoke

RapID NF PLUS System 20/KT
Model: R8311005
Lot: 3364798, 3364799, 3364800, 3381406, 3390383, 3442256 and 3442431

IVD: Multiple non-glucose fermenting bacteria species culture isolate identification IVD, kit

DE-1
FR-1
EN-1

Vk_20220722_05

26.07.2022

Laboratoires Chemineau

BENTRIO
Model: 7649998266062
Lot: CH113

MD: Nasal mucosa dressing, non-antimicrobial

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

Vk_20220720_28

26.07.2022

Albino Dias de Andrade

Gauze dressings with X-ray contrast thread, steril
Model: 22221.1
Lot: 0053922ES
S/N: 005165

MD: Cotton Gauzes, Folded, With X-ray Detectable Thread, Sterile

DE-1
FR-1

Vk_20220720_16

26.07.2022

Siemens Healthcare Diagnostics Inc

Dimension Vista CA 15-3 Flex reagent cartridge
Model: Dimension Vista; SMN 10464344
Lot: see FSN
S/N: N/A
SW-Version: N/A

IVD: Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20220720_03

22.07.2022

Messer Schweiz AG

Kohlendioxid med RPV
Model: 103020102
Lot: see FSN
S/N: See FSN

MD: Clinical/therapeutic Applications Carbon Dioxide

DE-1
FR-1

Vk_20220722_03

22.07.2022

Axon Biotech GmbH

Mueller-Hinton-Agar
Model: AL0901
Lot: see FSN

IVD: Other Prepared Media in Plates

DE-2
FR-1
EN-2

Vk_20220715_19

22.07.2022

Intuitive Surgical, Inc

Generator, E-100
Model: 374848-09
S/N: see FSN

MD: Electrosurgical system generator

DE-1
FR-1
EN-1

Vk_20220714_17

21.07.2022

Haemonetics S.A.

TEG 6s Hemostasis Analyzer
Model: 07-690
Lot: N/A
S/N: N/A
SW-Version: 1.7.2

IVD: Coagulation analyser IVD, laboratory, automated

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

Vk_20220715_03

12.07.2022

(Updated 21.07.2022)

KERI MEDICAL SA

KeriLock(R) – Screwed suture anchor kits 2.0 and 4.0
Model: 2.0 and 4.0; 500-B20001 and 500-B20002
Lot: KeriLock 2.0 : 20-0627 – 20-0628 – 20-0629, KeriLock 4.0 : 20-0631

MD: Tendon/ligament bone anchor, non-bioabsorbable

FR-1
EN-1

Vk_20220707_10

20.07.2022

GE Hangwei Medical Systems Co., Ltd

CT, PET, or NM table
Model: see FSN
Lot: see FSN

MD: X-Ray System, Diagnostic, Computed Tomography

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

Vk_20220713_15

20.07.2022

Datex-Ohmeda Inc.

Carestation 750, Carestation 750c
Lot: UNK

MD: Anaesthesia workstation, general-purpose

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

Vk_20220713_09

20.07.2022

bioMérieux SA

VIDAS FT4
Model: 30459
Lot: 1009142040, 1009140070, 1009168620, 1009384040, 1009434270
S/N: N/A
SW-Version: N/A

IVD: Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20220713_06

20.07.2022

Cardiac Pacemaker Inc

EMBLEM MRI S-ICD
Model: Model A219
Lot: N/A
S/N: To determine if a device is included in this Field Safety Notice, enter the model/serial number at www.BostonScientific.com/lookup, or review the customer list provided.
SW-Version: Model 3877 v1.03 and Model 2877 v4.09

Emblem S-ICD
Model: Model A209
Lot: N/A
S/N: To determine if a device is included in this Field Safety Notice, enter the model/serial number at www.BostonScientific.com/ lookup, or review the customer list provided.

MD: Subcutaneous Implantable Defibrillators

AIMD: Single-chamber implantable defibrillator

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

Vk_20220708_04

13.07.2022

(Updated 20.07.2022)

Smith & Nephew, Inc.

Werewolf Flow 90° Wand
Model: 72290038
Lot: 2086510, 2087447, 2087448, 2087450, 2087451, 2087452, , 2087449, 2087969, 2087970 and 2087986

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

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

Vk_20220706_08

19.07.2022

ev3

EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
Model: all
Lot: all

MD: Peripheral artery stent, bare-metal

DE-1
FR-1
IT-1

Vk_20220714_26

19.07.2022

Medicina Ltd

ENFit Enteral Syringe
Model: LHE01LD, LHE25LD, LHE05, OT005, OT01, OT25, OT05, OTH01, OTH25, OTH05; LHE01LD, LHE25LD, LHE05, OT005, OT01, OT25, OT05, OTH01, OTH25, OTH05

MD: ENFit oral/enteral syringe, single-use; ENFit oral/enteral syringe, reusable

DE-1
FR-1
IT-1

Vk_20220714_25

15.07.2022

(Updated 19.07.2022)

Siemens Healthcare GmbH

Axiom Sensis
Model: See FSN

AXIOM Sensis XP
Model: See FSN

AXIOM Sensis Lite
Model: See FSN

AXIOM Sensis Vibe Combo
Model: See FSN

MD: Cardiac catheterization laboratory computer

MD: Cardiac catheterization laboratory computer

MD: Cardiac catheterization laboratory computer

MD: Cardiac catheterization laboratory computer

DE-1
FR-2
EN-1

Vk_20220711_22

29.06.2022

(Updated 19.07.2022)

Maquet Critical Care AB

SERVO-air
Model: 6682000
SW-Version: N/A

MD: Neonatal/adult intensive-care ventilator

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

Vk_20220628_04

29.06.2022

(Updated 19.07.2022)

Maquet Critical Care AB

SERVO
Model: 6694800 Servo-u; 6688600 Servo-n; 6888800 Servo-u MR; 6682000 Servo-air

MD: General-purpose intensive-care ventilator

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

Vk_20220623_10

17.05.2022

(Updated 19.07.2022)

BECTON DICKINSON INFUSION THERAPY AB

BD Connecta Stopcock Without Extension Tube
Model: 394600; 394601; 394602
Lot: See FSN

BD Nexiva Closed IV Catheter System
Model: 383682; 383687
Lot: See FSN

MD: Intravenous line stopcock

MD: Intravenous line stopcock

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

Vk_20220512_09

15.07.2022

Renishaw Mayfield SARL

Neuroinpsire
SW-Version: All software versions

MD: Image segmentation application software

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

Vk_20220707_07

14.07.2022

DePuy Ireland

ATTUNE Measured Sizing & Rotation Guide Instrument
Model: 254400525
Lot: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, AB5034303
S/N: 10603295434061

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1
EN-1

Vk_20220629_25

13.07.2022

Siemens Healthcare Diagnostics Inc

Atellica CH Iron_2
Model: 11097601
Lot: All lots
S/N: N/A
SW-Version: N/A

IVD: Iron IVD, kit, spectrophotometry

DE-1
FR-1
EN-1

Vk_20220701_05

07.07.2022

(Updated 13.07.2022)

Mallinckrodt Manufacturing LLC

INOmax DSIR
S/N: All

MD: Nitric oxide delivery unit, system-based

DE-1
IT-1
EN-1

Vk_20220629_01

12.07.2022

GE Healthcare Finland Oy

Centricity High Acuity Critical Care
SW-Version: CHA Critical Care and Anesthesia 5.2 to 5.8

MD: Patient health record information system

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

Vk_20220711_26

12.07.2022

Cardiac Pacemaker Inc

Zoom Latitude Programmer
Model: 3120
S/N: To determine if a device is included in this Field Safety Notice, enter the model/serial number at www.BostonScientific.com/lookup
SW-Version: Model 2868

AIMD: Cardiac pulse generator programmer

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

Vk_20220708_02

05.07.2022

(Updated 12.07.2022)

OphthalmoPro GmbH

Optyluron NHS

MD: Shields, Mechanical, Eye

DE-1
EN-1

Vk_20220705_09

12.07.2022

Stryker Instruments-a division of Stryker Corp

2.3MM TAPERED ROUTER
Model: 5820071023
Lot: 22011017 , 21330017 , 20216017 , 20140017, 20139027

MD: Cranial bur, single-use

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

Vk_20220701_04

14.06.2022

(Updated 12.07.2022)

Covidien LLC

PALINDROME
Lot: 17144xxxxx through 22038xxxxx.
S/N: see FSN
SW-Version: N/A

MD: Double-lumen haemodialysis catheter, implantable

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

Vk_20220608_15

22.03.2022

(Updated 12.07.2022)

Respironics California, LLC

V60 Ventilator

V60 Plus Ventilator

V680 Ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: General-purpose intensive-care ventilator

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

Vk_20220314_28

05.07.2022

(Updated 11.07.2022)

HeartWare Inc.

HeartWare Ventricular Assist System
Model: 1650DE
S/N: All
SW-Version: N/A

AIMD: Implantable ventricular circulatory assist system

DE-1A
DE-1B
EN-1A
EN-1B

Vk_20220629_24

01.12.2021

(Updated 08.07.2022)

Qiagen GmbH

QIAcube Connect MDx
Model: 9003070
Lot: n/a
S/N: All
SW-Version: n/a

IVD: Nucleic Acid Testing Extraction Instruments

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

Vk_20211126_06

07.07.2022

Hegewald Medizinprodukte GmbH

MIB Infusionsmischbeutel
Model: 1021700, 1021720, 1021705
Lot: BMH70012, BLH70011, BMH72004, CCH70502

MD: Medical Bags

DE-1

Vk_20220629_16

08.06.2022

(Updated 07.07.2022)

3M ESPE Dental Products

3M ESPE Filtek Supreme Flowable Restorative Caps.
Model: 6033A1, 6033A2, 6033A3, 6033A3.5, 6033B1, 6033B2, 6033C2, 6033OA3
Lot: NF15043, NE98405, NF05501, NF10756, NF11091, NF10945, NE99885, NE88238, NE87132, NE87133

MD: Dental composite resin

DE-1
FR-1
IT-1

Vk_20220601_15

06.07.2022

GE Healthcare IITS USA Corporation

Centricity PACS
SW-Version: Centricity PACS 7.0 SP0.0.4.7

MD: Radiology picture archiving and communication system

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

Vk_20220704_25

06.07.2022

GE Healthcare IITS USA Corporation

Centricity Universal Viewer Zero Footprint Client
SW-Version: Versions 6.0 SP6 through 6.0 SP11.4

MD: Medical image management system

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

Vk_20220628_06

05.07.2022

Getinge Disinfection AB

ED-FLOW, ED-FLOW SD
Model: ED-FLOW, ED-FLOW SD
S/N: All ED-FLOW AER-models manufactured since start 2010 until 2022-05-05

MD: Endoscope washer/disinfector

DE-1
EN-1

Vk_20220704_27

05.07.2022

Dynex Technologies

Agility Automated ELISA System
Model: 67800 (Software)
SW-Version: 1.4.3

IVD: Multiple clinical chemistry analyser IVD, laboratory, automated

EN-1

Vk_20220704_04

05.07.2022

Biomerieux

NucliSENS easyMAG Magnetic Silica
Model: 280133
Lot: See FSN

IVD: Nucleic acid extraction/isolation kit IVD

DE-1
FR-1
EN-1

Vk_20220704_02

02.06.2022

(Updated 01.07.2022)

Waldemar Link GmbH & Co. KG

Endo-Model-M
Model: tibial components, see FSN
Lot: All after manufacturing date 2021-08 until manufacturing date 2022-05

Endo-Model SL
Model: tibial components, see FSN
Lot: All after manufacturing date 2021-08 until manufacturing date 2022-05

MD: Uncoated knee tibia/insert prosthesis

MD: Rotating hinged total knee prosthesis

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

Vk_20220523_16