Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2023 – 30.09.2023  

28.09.2023

GE Healthcare Finland Oy

Frame F2-01
Lot: see FSN

MD: Patient monitoring system module rack

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

Vk_20230920_09

19.09.2023 

(Updated 28.09.2023)

Weinmann Emergency Medical Technology GmbH + Co. KG

Einweg-Patientenschlauchsysteme VENTcirc-MMT
Model: see FSN
Lot: Produktionsdatum 2022-10-04 bis 2023-05-25

MD: Anaesthesia breathing circuit, single-use

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

Vk_20230919_02

27.09.2023

RaySearch Laboratories AB (publ)

RayCare
Model: 5B and 6A including service packs
S/N: 5.1.1.60246, 5.1.3.60023, 6.0.0.60553
SW-Version: 5B SP1, 5B SP3, 6A

MD: Various Radiotherapy And Radiosurgery Instruments – Software Accessories

EN-1

Vk_20230921_07

26.09.2023

Olympus Medical Systems Corp.

Thunderbeat Type – S
Model: TB-0535FCS for Thunderbeat Type S, 35 cm and TB-0545FCS for Thunderbeat Type S, 45 cm; EGTB-0535FCS for Thunderbeat Type S, 35 cm / TB-0535FCS and EGTB-0545FCS for Thunderbeat Type S, 45 cm / TB-0545FCS
Lot: see FSN

MD: Soft-tissue ultrasonic surgical system holder/tip, single-use

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

Vk_20230922_01

26.09.2023

Zimmer Surgical, Inc.

Zimmer Dermatome Blades
Model: 00-8800-000-10
Lot: see FSN

MD: Dermatome blade, single-use

DE-1
IT-1

Vk_20230920_01

23.11.2022 

(Updated 26.09.2023)

Leica Microsystems (Schweiz) AG

PROvido
Model: 10448950, 10448976
S/N: 91221002, 190122001, 290622001, 80822001, 101221002, 250122002, 261122001, 71222001, 270623001

Leica M530 OHX
Model: 10448737, 10734920, 10745322, 10449088
S/N: 121221001, 41122001, 150423001

PROVEO 8
Model: 10449039, 10449058, 10448808
S/N: 210122001, 310522001, 20922001, 11222001, 101022001

MD: General-purpose surgical microscope

MD: Neurosurgical microscope

MD: Ophthalmic slit lamp, surgical

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

Vk_20221116_05

25.09.2023

Topro Industri AS

TOPRO Hestia
Model: 815500; 119010
Lot: 0000217232 to 0000224525, 0000225043 to 0000225709
S/N: 0000217232001 to 0000224525120, 0000225043001 to 0000225709135
SW-Version: /

MD: Wheeled Walker

DE-1
FR-1
IT-1

Vk_20230919_01

25.09.2023

Roche Diabetes Care GmbH

Accu-Chek Solo reservoir
Model: 07858850001

MD: Portable Microinfusion Instruments – Consumables

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

Vk_20230905_19

25.09.2023

Roche Diabetes Care GmbH

Accu-Chek Solo Cann&P-hold 6mm
Model: 08928495001

Accu-Chek Solo Cann&P-hold 9mm
Model: 08928517001

Accu-Chek Solo Insertion Device
Model: 07835540001

MD: Kit For Continuous Subcutaneous Insulin Infusion

MD: Kit For Continuous Subcutaneous Insulin Infusion

MD: Needle Introducers

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

Vk_20230905_18

14.09.2023 

(Updated 25.09.2023)

Hamilton Medical AG

In2Flow Nasal cannula
Model: 10076606, 10076605, 10076604
Lot: all

MD: Air/oxygen Masks And Nasal Cannulas

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

Vk_20230828_16

29.08.2023 

(Updated 22.09.2023)

Techno-path Manufacturing Ltd.

Multichem controls
Model: see FSN
Lot: see FSN
S/N: N/A
SW-Version: N/A

IVD: Multiple-type clinical chemistry analyte profile IVD, control

DE-1 (Abbott)
DE-1 (LGC)
FR-1 (Abbott)
FR-1 (LGC)
IT-1 (Abbott)
IT-1 (LGC)
EN-1 (Abbott)
EN-1 (LGC)

Vk_20230825_10

21.09.2023

Shimadzu Corporation

FDR Visionary Suite
S/N: MP95A9C89008

MD: Stationary basic diagnostic x-ray system, digital

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

Vk_20230913_17

20.09.2023

Cardiac Pacemaker Inc

EMBLEM S-ICD
Model: A209
S/N: All

EMBLEM S-ICD Programmer
Model: 3200
SW-Version: 2877 v4.10

LATITUDE Programmer
Model: 3300
SW-Version: 3877 v1.04

EMBLEM MRI S-ICD
Model: A219
S/N: All

AIMD: Single-chamber implantable defibrillator

AIMD: Cardiac pulse generator programmer

AIMD: Cardiac pulse generator programmer

MD: Subcutaneous Implantable Defibrillators

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

Vk_20230914_02

20.09.2023

NEXUS / DIS GmbH

NEXUS / PDMS
SW-Version: 2.9

MD: Vital Signs Monitoring Instruments – Medical Device Software

DE-1

Vk_20230912_22

19.09.2023

Datascope Corp.

Intra-aortic Balloon Catheter
Model: see attached with descriptions; see attached with descriptionssee attached with descriptions
Lot: All
S/N: device is not serialized
SW-Version: N/A

MD: Intra-aortic balloon catheter

DE-1
FR-1
IT-1

Vk_20230913_24

19.09.2023

Siemens Healthcare GmbH

Cios VA30-Systeme

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

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

Vk_20230913_03

19.09.2023

Beckman Coulter , Inc.

DxI 9000 Access Immunoassay Analyzer
Model: C11137
SW-Version: 1.15 or prior

IVD: Chemiluminescent immunoassay analyser IVD

DE-1
EN-1

Vk_20230913_02

19.09.2023

Siemens Healthcare Diagnostics Inc.

Atellica IM Free Beta Human Chorionic Gonadotropin (FBHCG), ADVIA Centaur Free Beta Human Chorionic Gonadotropin (FBHCG)
Model: 10733009, 10994996
Lot: 52211034, 54264037, 52212035, 54265036
S/N: n/a

IVD: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20230906_24

15.09.2023

Becton Dickinson Diagnostic Systems

BD BACTEC Plus Aerobic/F Culture Vials
Model: 442023
Lot: 3062843, 3062846, 3062849, 3062847, 3067489, 3067488

IVD: Culture medium antimicrobial supplement IVD

DE-1
FR-1
EN-1

Vk_20230908_18

30.08.2023 

(Updated 15.09.2023)

Philips Medical Systems Nederland B.V

MultiDiagnost Eleva

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

DE-1
EN-1

Vk_20230828_10

17.02.2023 

(Updated 15.09.2023)

Nidek & Co Ltd

SZ-1C, SZ-1
S/N: See FSN

Preloaded EyeCee One IOL
Model: EYEC1CRYPRE, EYEC1PRE
S/N: See FSN

MD: Posterior-chamber intraocular lens, pseudophakic

MD: Posterior-chamber intraocular lens, pseudophakic

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

Vk_20230209_11

14.09.2023

ResMed PTY LTD

Astral 100, Astral 150
Model: 27033 (Model: 100, 150)
S/N: 20142483483 – 22191006942

MD: Portable electric ventilator

DE-1
FR-1

Vk_20230912_01

14.09.2023

Philips Medical Systems DMC GmbH

Essenta DR Compact
Model: 712072

MD: Computed radiography digital imaging scanner

DE-1
FR-1

Vk_20230817_06

12.09.2023

GE Healthcare

Centricity Enterprise Archive; Enterprise Archive
SW-Version: See FSN

MD: Radiological PACS software

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

Vk_20230911_03

12.09.2023

Joimax GmbH

joimax, Versicon Spine Pump
Model: JISP3000
SW-Version: C1.3

MD: Surgical irrigation pump

DE-1
FR-1
EN-1

Vk_20230830_18

15.08.2023 

(Updated 12.09.2023)

Accuray Incorporated

Single Energy Linear Accelerators
S/N: See consignment list

MD: Single Energy Linear Accelerators

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

Vk_20230814_06

07.03.2022 

(Updated 12.09.2023)

Siemens Healthcare GmbH

Artis zee

Artis Q

Artis Q.zen

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

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

Vk_20220224_16

02.06.2023 

(Updated 11.09.2023)

Roche Diabetes Care GmbH

Accu-Chek Solo Diabetes Manager
Model: 07859481001, 07859490001
Lot: All Accu-Chek Solo Data Managers with firmware versions 20.33 or 20.55

MD: General Medicine Therapeutic Treatment Instruments

DE-1.1
DE-1.2
DE-2.1a
DE-2.1b
DE-2.1c
DE-2.2
FR-1.1
FR-1.2
FR-2.1a
FR-2.1b
FR-2.1c
FR-2.2
IT-1.1
IT-1.2
IT-2.1a
IT-2.1b
IT-2.1c
IT-2.2

Vk_20230531_33

08.09.2023

Balt Extrusion

HYBRID
Model: HYBRID 12D300
Lot: see FSN

MD: Cardiac/peripheral vascular guidewire, single-use

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

Vk_20230905_17

06.09.2023

Serres Oy

Pre-gelled bag 2000 ml
Model: 57567-0
Lot: 1109986

MD: Collection Bags And Other Containers For Drainages And Fistulas, Single Use

DE-1
FR-1
IT-1

Vk_20230901_12

04.09.2023

Smiths Medical ASD, Inc.

24G Jelco IV Catheter
Model: 4013
Lot: 4306605

MD: Peripheral intravenous cannula

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

Vk_20230904_14

04.09.2023

Philips Medizinsysteme Böblingen GmbH

Patient Information Center iX
Model: 866389, 866390, 867093, 867154

MD: Centralized patient monitor

DE-1
FR-1
EN-1

Vk_20230824_19

04.09.2023

Mediprema

Incubator NITE
Model: 5020
S/N: 5020-3082
SW-Version: 1.5 / 1.4 / 1.2

MD: Mobile Neonatal Incubators

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

Vk_20230822_20

01.07.2022 

(Updated 01.09.2023)

Integra LifeSciences Corp

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

CereLink ICP Extension cable
Model: 826845
Lot: All lot number available in the market

MD: Intracranial pressure monitor

MD: Intracranial/compartmental-pressure monitor calibrator/cable

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

Vk_20220628_01

22.12.2020 

(Updated 01.09.2023)

HeartWare Inc.

HeartWare Ventricular Assist System – HVAD Pump Implant Kit
Model: 1104
S/N: all

AIMD: Implantable ventricular circulatory assist system

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

Vk_20201218_18

31.08.2023

Perouse Medical

POLYFILM
Model: PF121401; VPEPF121401
Lot: A200006, A210007, A210008, A220009, A220010

MD: Synthetic polymer semi-permeable film dressing, adhesive

DE-1

Vk_20230811_29

30.08.2023

Siemens Healthcare GmbH

Over-ear Headphones for Magnetom Systems
Model: 11060845
Lot: 7981 to 32200

MD: Magnetic resonance imaging (MRI) unit, full-body

DE-1
FR-1
IT-1

Vk_20230828_06

30.08.2023

B. Braun Melsungen AG

Original Perfusor Line
Model: 8255490
Lot: 23D12E8SM3

MD: Intravenous administration tubing extension set

DE-1

Vk_20230824_21

30.08.2023

Thommen Medical AG

SPI ELEMENT impl. RC INICELL
Model: 4.23.142
Lot: 31265

MD: Screw endosteal dental implant, two-piece

DE-1
EN-1

Vk_20230824_05

30.08.2023

DH Healthcare GmbH

ORBIS Medication 3.x

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20230822_25

30.08.2023

PHARMAOUEST INDUSTRIES

ARPEGIA, AUXILIA

MD: Belts, Seats And Armrests For Wheelchairs

FR-1

Vk_20230822_18

22.08.2023 

(Updated 30.08.2023)

QuidelOrtho (Ortho-Clinical Diagnostics Inc.)

VITROS XT7600
Model: 6844461
SW-Version: Not Applicable

VITROS Systems
Model: see FSN
SW-Version: Not Applicable

IVD: Multiple clinical chemistry analyser IVD, laboratory

IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE

DE-1
EN-1

Vk_20230817_04

16.08.2023 

(Updated 30.08.2023)

DePuy Ireland

Attune Cementless Cruciate Retaining (CR) Femur
Model: 1504-01-204
Lot: 3883327

MD: Coated knee femur prosthesis

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

Vk_20230814_04

17.05.2022 

(Updated 30.08.2023)

MAQUET Cardiopulmonary GmbH

Heater Unit HU35
Model: 70103.5259; 70104.9090; 70107.2162; 70107.2163
S/N: All HU 35 units are affected since production start up to serial number 90039999 (HU 35, 230 V) and up to serial number 90035999 (HU35, 115 V)

MD: Cardiopulmonary bypass system heat exchanger, reusable

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

Vk_20220510_20

29.08.2023

Thoratec Corporation

HeartMate 3 LVAS
Model: 1050; 106524INT; 1050; 106524INT

AIMD: Implantable ventricular circulatory assist system

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

Vk_20230823_16

29.08.2023

Ulrich AG

Elektrochirurgische Pinzetten
Lot: all
S/N: all

MD: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

DE-1
FR-1
IT-1

Vk_20230821_17

02.08.2023 

(Updated 29.08.2023)

Covidien llc

Hugo RAS Arm Cart Assembly
Model: MRASC0002
S/N: All
SW-Version: 1.2

MD: Robot-assisted Endoscopic Surgery Systems

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

Vk_20230731_14

28.08.2023

DH Healthcare GmbH

ORBIS Medication 3.x

MD: General Medicine Instruments – Other

DE-1

Vk_20230818_04

25.08.2023

Chromsystems Instruments & Chemicals GmbH

MassCheck Drugs of Abuse Testing Urine Control Level I
Model: 0410 / 0410
Lot: 0623

IVD: Multiple drugs of abuse IVD, control

DE-1
FR-1
IT-1

Vk_20230816_12

24.08.2023

Medline International France SAS

Magnetic Instrument Drape MDL1CE
Model: MDL1CE
Lot: GMD22W02

MD: Sharp surgical instrument counting tray/pad, single-use

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

Vk_20230822_14

24.08.2023

St. Jude Medical Cardiac Rhythm Management Division

Gallant, Neutrino, Entrant ICD and CRT-D
Model: CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA600Q, CDDRA600Q, CDHFA600Q, CDVRA300Q, CDDRA300Q, CDHFA300Q
S/N: Serial numbers manufactured between Dec. 2019 and April 2022
SW-Version: 25.8.2 rev. 1 or higher and 1.8.2 rev. 1 or higher

AIMD: Dual-chamber implantable defibrillator

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

Vk_20230817_17

24.08.2023

Johnson & Johnson International

VICRYL Polyglactin 910 Suture
Model: W9378, W9287, V908E, V755G
Lot: TEBBPPT0, TEBBDJT0, TEBBCGQ0, TDBBGHR0

MD: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

FR-1

Vk_20230811_26

02.08.2023 

(Updated 24.08.2023)

Nouvag AG

Dispenser DP30
Model: 4180, 4180-230ang, 4180cov, 4180int, 4180med
Lot: All devices on market before 31.06.2023

MD: Bedside infusion pump, single-channel

DE-2
FR-2
EN-3

Vk_20230731_10

23.08.2023

B. Braun Melsungen AG

Infusomat Space
Model: 8713050
S/N: see FSN

MD: Bedside infusion pump, single-channel

DE-1
FR-1
IT-1

Vk_20230818_26

23.08.2023

B. Braun Melsungen AG

Spaceplus Infusomat
Model: 8719050
S/N: see FSN

MD: Bedside infusion pump, single-channel

DE-1
FR-1
IT-1

Vk_20230818_25

23.08.2023

CamDiab Ltd

mylife CamAPS
SW-Version: 1.4(172).101 and earlier

MD: General Medicine Therapeutic Treatment Instruments – Software Accessories

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

Vk_20230811_30

03.08.2023 

(Updated 23.08.2023)

Ethicon LLC

PDS II Suture
Model: N/A; Attachment – Product details
Lot: Attachment – Product details
S/N: N/A
SW-Version: N/A

MD: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

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

Vk_20230731_22

03.08.2023 

(Updated 23.08.2023)

Ethicon Endo-Surgery, LLC

PDS Plus Antibacterial Suture
Model: N/A; Attachment – Product details
Lot: Attachment – Product details
S/N: N/A
SW-Version: N/A

MD: Polyester suture, bioabsorbable, monofilament, antimicrobial

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

Vk_20230731_21

22.08.2023

Siemens Healthcare Diagnostics Inc.

ADVIA Chemistry Iron_2 (IRON_2) Reagents
Model: see FSN
Lot: All lots affected

IVD: Iron IVD, kit, spectrophotometry

DE-1
EN-1

Vk_20230821_13

22.08.2023

Medacta International SA

Humeral reverse metaphysis +0mm/0°
Model: 04.01.0110
Lot: 2300354

MD: Reverse shoulder prosthesis body

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

Vk_20230816_11

15.08.2023 

(Updated 21.08.2023)

Tosoh Corporation

AIA-CL 300 Immunoassay Analyzer
Model: 0024450
SW-Version: 1.04

IVD: Automated Immunochemistry Analysers – Low Routine (throughput <= 100 Test/h)

DE-1
EN-1

Vk_20230814_11

04.01.2023 

(Updated 21.08.2023)

MAQUET Cardiopulmonary GmbH

PLS Set
Model: 701068386, 701068389, 701076706, 701068390
Lot: see Annex I of FSN

HLS Set Advanced
Model: 701069073, 701069076, 701069083, 701069079
Lot: see Annex I of FSN

MD: Cardiopulmonary bypass system blood tubing set

MD: Cardiopulmonary bypass system blood tubing set

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

Vk_20230103_01

15.08.2023 

(Updated 18.08.2023)

Diagnostic Grifols SA

Erytra Eflexis
Model: 210600
Lot: NA
SW-Version: 3.0.1

IVD: Blood group/antibody screening analyser IVD

DE-1
FR-1
EN-1

Vk_20230810_21

09.08.2023 

(Updated 18.08.2023)

Olympus Medical Systems Corp.

Disposale EMR Kit
Model: See FSN
Lot: See FSN

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

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

Vk_20230807_11

17.08.2023

CooperSurgical Inc.

H/S ELLIPTOSPHERE CATH, H/S CATHETER SET FR 5 WITH
Model: 61-4005S, 61-4005, 61-3005
Lot: 61-4005S – 309967, 61-4005 – 313121, 313568, 61-3005 -312868

MD: Intrauterine imaging medium catheterization kit

DE-1

Vk_20230809_14

17.08.2023

ACUTRONIC Medical Systems AG

Acutronic Medical Systems AG TV1 Ventilator
Model: 7050.IB; 7250.IB, 122011
S/N: All
SW-Version: All

MD: Neonatal/paediatric Pulmonary Ventilators

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

Vk_20230727_07

16.08.2023

Paul Hartmann AG

Protect Plus Patient drapes CombiSet and Foliodrape
Model: See FSN
Lot: See FSN

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

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

Vk_20230809_22

08.08.2023 

(Updated 16.08.2023)

Löwenstein Medical SE & Co. KG

elisa 300
Model: ag-480300, ag-480310
SW-Version: < 1.11.3, 2.04.7, 2.09.14, 2.10.6 or 2.13.2

elisa 500
Model: ag-480500, ag-480510
S/N: 0520073
SW-Version: < 1.11.3, 2.04.7, 2.09.14, 2.10.6 or 2.13.2

elisa 600
Model: 400600, ag-370600, ag-370605
S/N: 0400600hul06184472, 0400600hul06174042
SW-Version: < 1.11.3, 2.04.7, 2.09.14, 2.10.6 or 2.13.2

elisa 800
Model: 400810, ag-370830, ag-370835
S/N: 0400810hul08184084, 0400810hul08184085, 0400810hul08184077, 0400810hul08184078, 0400810hul08184082, 0400810hul08184083, 0400810hul08174055, 0400810hul08215608
SW-Version: < 1.11.3, 2.04.7, 2.09.14, 2.10.6 or 2.13.2

elisa 800 vit
Model: 400800, ag-370830-vit, ag-370835-vit, ag-370836-vit
S/N: 0400800hul08150086, 0400800hul08189033, 0400800hul08179006, 0400800hul08179017, 08230551
SW-Version: < 1.11.3, 2.04.7, 2.09.14, 2.10.6 or 2.13.2

MD: Intensive care ventilator

MD: Intensive care ventilator

MD: Intensive care ventilator

MD: Intensive care ventilator

MD: Intensive care ventilator

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

Vk_20230807_19

16.08.2023

Olympus Medical Systems Corp.

BF-Series Endoscopes
S/N: all

MD: Flexible video bronchoscope, reusable

DE-1
FR-1
IT-1

Vk_20230803_07

15.08.2023

MAQUET Cardiopulmonary GmbH

MEERA operating table with autodrive
Model: 7200.01B2, 7200.01F2, 7100.01B2
S/N: 720001B2 – SN 6 – 11046, 720001F2 – SN 3 – 599, 710001B2 – SN 1 – 252

MD: Universal operating table, electrohydraulic

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

Vk_20230814_23

15.08.2023

GeneProof a.s.

myCROBE Fully Automated Instrument
Model: MC100
Lot: N/A
SW-Version: 2.2.2

IVD: Nucleic acid sample preparation instrument IVD

EN-1

Vk_20230814_22

15.08.2023

Covidien llc

McGRATH MAC2 Video Laryngoscope Blade
Model: 350-017-000, 350-084-000
Lot: 22082207, 22083101, 22102001

MD: Laryngoscope blade, single-use

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

Vk_20230811_18

15.08.2023

Arthrex INC

Knee Scorpion
Model: AR-12990
Lot: 15089076, 15089069, 15095444, 15095447, 15095450, 15095547, 15096955, 15096951, 15096956, 15103245, 15104165, 15104167, 15112381, 15112380

MD: Suturing unit, reusable

DE-1
FR-1
IT-1

Vk_20230811_17

14.08.2023

Berlin Heart GmbH

EXCOR Cannula
Model: all
Lot: all

MD: External ventricular circulatory assist system

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

Vk_20230814_14

28.07.2023 

(Updated 14.08.2023)

Sartorius Stedim Biotech GmbH

Sartorius Minisart NML
Model: 16596-HYK, 16596-ZSK, 17575-ACK, 17575-ZSK, 16596-HYQ, 16599-HYQ
Lot: see FSN

MD: Laboratory syringe filter

DE-01
FR-01
IT-01
EN-01
EN-02
EN-03

Vk_20230724_42

06.06.2023 

(Updated 14.08.2023)

bioMérieux

EBV R-GENE
Model: 69-002B
Lot: see FSN
S/N: N/A
SW-Version: N/A

BK Virus R-GENE
Model: 69-013B
Lot: see FSN

IVD: Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20230531_05

03.08.2023 

(Updated 14.08.2023)

Boston Scientific Corporation

Guider Softip XF Guide Catheter
Model: see FSN
Lot: see FSN

MD: Vascular guide-catheter, single-use

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

Vk_20230221_01

03.08.2023 

(Updated 11.08.2023)

OBA AG

Anti-Decubitus Mattresses
Model: 5001, Motus; 3008, Hospisoft; 3020 Evoba, EvoPore, Evosoft; 3010, Memoba; 3001 Airsoft, Airsoft Duo
Lot: Manufacturing date from 2023-02 to 2023-07

MD: Non Active Anti-decubitus Medical Mattresses

DE-2
FR-2

Vk_20230728_32

10.08.2023

EQUIMEDICAL

Equitamp Equicel Equispon

MD: Plant polysaccharide haemostatic agent, bioabsorbable

EN-1

Vk_20230808_03

07.08.2023 

(Updated 10.08.2023)

Hamilton Medical AG

HAMILTON-MR1
Model: 161010
S/N: See FSN

HAMILTON-T1
Model: 161006; 161009
S/N: See FSN

HAMILTON-C1
Model: 161001
S/N: See FSN

MD: Respiratory And Anaesthesia Devices – Other

MD: Respiratory And Anaesthesia Devices – Other

MD: Respiratory And Anaesthesia Devices – Other

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

Vk_20230727_01

25.07.2023 

(Updated 10.08.2023)

Getinge Disinfection AB

APERLAN POKA-YOKE Agent A & Agent B
Model: APERLAN PY AGENT A, APERLAN PY AGENT B
Lot: All Batches of Aperlan poka yoke agent A and Aperlan poka yoke agent B produced until 2023-07-04.

MD: Peroxy acid device disinfectant, organic

DE-1
EN-1

Vk_20230719_02

26.07.2021 

(Updated 10.08.2023)

ACUTRONIC Medical Systems AG

fabian +nCPAP evolution
Model: 122001, 122012

fabian Therapy evolution
Model: 121001, 121012

Fabian HFO
Model: 111001, 111001.01, 112001, 113001

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

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

Vk_20210712_10

09.08.2023

Henke-Sass Wolf GmbH

Henke-Ject
Model: 4100.000V0
Lot: see FSN
S/N: n/a

MD: Metered-delivery hypodermic syringe

DE-EN-1

Vk_20230725_02

02.08.2023 

(Updated 09.08.2023)

Shimadzu Corporation

CEILING TUBE SUPPORT
Model: CH-200; CH-200M

RADspeed
Model: PRO; safire

MD: Stationary basic diagnostic x-ray system, digital

MD: Stationary basic diagnostic x-ray system, digital

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

Vk_20230720_10

08.08.2023

OCULUS Optikgeräte GmbH

Myopia Master – Optiswiss
Model: 10010728
S/N: see FSN
SW-Version: n/a

MD: Corneal topography system

DE-1
FR-1
IT-1

Vk_20230807_10

03.08.2023 

(Updated 08.08.2023)

Thoratec Corporation

HeartMate Touch Communication System
Model: HMT1150
S/N: All serial numbers

AIMD: Multiple active implantable device programmer

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

Vk_20230802_02

08.08.2023

Haiyan Kangyuan Medical Instrument Co.,Ltd.

Silicone Foley Catheter with Temperature Probe for single use
Model: three cavity, four cavity; specification: 6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr
Lot: all

MD: Temperature-monitoring indwelling urethral drainage catheter

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

Vk_20230627_19

06.08.2023

astraia software GmbH

NEXUS / Geburtshilfe – CTG-Überwachung
SW-Version: 7.1.8.100

MD: Central Information Computing Systems

DE-1

Vk_20230802_01

06.08.2023

Drägerwerk AG & Co. KGaA

HME TwinStar Plus

MD: Heat/moisture exchanger/microbial medical gas filter

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

Vk_20230728_24

06.08.2023

Wassenburg Medical B.V

WASSENBURG WD4200 washer-disinfector

MD: Endoscope washer/disinfector

DE-1
FR-1
IT-1

Vk_20230726_10

28.07.2023 

(Updated 04.08.2023)

Waldemar Link GmbH & Co. KG

Link OptiStem, Rasp Handle Stainless Steel
Model: 17-5220/01
Lot: C010108, C151519

MD: Surgical instrument handle, non-torque-limiting

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

Vk_20230725_01

04.08.2023

RaySearch Laboratories AB (publ)

RayCare
Model: RayCare 6A
S/N: 6.0.0.60553
SW-Version: 6A

MD: Various Radiotherapy And Radiosurgery Instruments – Software Accessories

EN-1

Vk_20230719_11

04.08.2023

RaySearch Laboratories AB (publ)

RayCare
Model: RayCare 5A, 5B, 6A
S/N: 5.0.0.60390, 5.0.1.60052, 5.1.1.60246, 5.1.2.60028, , 5.1.3.60023, 6.0.0.60553
SW-Version: 5A, 5B, 6A

MD: Various Radiotherapy And Radiosurgery Instruments – Software Accessories

EN-1

Vk_20230718_14

06.03.2023 

(Updated 04.08.2023)

St. Jude Medical

Trifecta Valve
Model: TF-19A, TF-21A, TF23A, TF25A, TF-27A, TF-29A, TFGT-19A, , TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, and TFGT-29A
S/N: All serial numbers
SW-Version: N/A

MD: Aortic heart valve bioprosthesis

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

Vk_20230227_28

03.08.2023

Medtronic Navigation Inc.

O-arm O2 Imaging System
Model: BI70002000
S/N: C2841, C2781, C2918, C3290

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

FR-1
EN-1

Vk_20230725_15

02.08.2023

Siemens Medical Solutions USA, Inc.

Symbia Pro.specta

MD: SPECT/CT system

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

Vk_20230725_26

31.07.2023

BIOTRH s.r.o

Los Deline
Lot: See FSN

MD: Dermal tissue reconstructive material, synthetic polymer, bioabsorbable

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

Vk_20230731_03

31.07.2023

Abbott Medical

Proclaim XR SCS and Proclaim Elite SCS System
Model: 3660; 3662

Infinity Deep Brain Stimulation (DBS) IPG
Model: 6660; 6662

Proclaim DRG Neurostimulation System
Model: 3664

AIMD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

AIMD: Deep brain electrical stimulation system

AIMD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

DE-1
FR-1
IT-1

Vk_20230720_11

31.07.2023

International Biomedical

NxtGen Infant Transport Incubator
Model: 732-0000
S/N: NX 100 / NX101 / NX104 / NX105 / NX 111

MD: Transport infant incubator

EN-1

Vk_20230703_01

27.07.2023 

(Updated 29.07.2023)

Edwards Lifesciences LLC

Edwards PASCAL Precision
Model: 20000IS and 20000ISM
S/N: 20000IS: 10875150; 20000ISM: 10809849, 10809852, 10903936, 10903937, 10921752, 10921754, 10700424, 10864947, 10844564

MD: Vascular And Cardiac Prostheses – Other

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

Vk_20230726_08

28.07.2023

W.O.M. World of Medicine GmbH

Aquilex Fluid Control System
Model: AQL-100PBS, AQL-100P
S/N: see FSN

MD: Hysteroscopic irrigation/insufflation system

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

Vk_20230718_17

01.02.2023 

(Updated 28.07.2023)

Siemens Healthcare Diagnostics Inc.

Atellica CH Total Bilirubin_2; Atellica CH LDL Cholesterol; Atellica CH Gamma-Glutamyl Transferase; Atellica CH HDL Cholesterol
Model: SMN 11097531; SMN 11537214; SMN 11097597; SMN 11537213
Lot: all

Atellica CH LDL Cholesterol Direct (DLDL)
Model: SMN 11097632
Lot: all
S/N: N/A

Atellica CH Total Protein II (TP)
Model: SMN 11097604
Lot: all
S/N: N/A

Atellica CH Triglycerides (Trig)
Model: SMN 11097591
Lot: all
S/N: N/A

Atellica CH Triglycerides_2 (Trig)_2
Model: SMN 11537222
Lot: all
S/N: N/A

IVD: CLINICAL CHEMISTRY

IVD: Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry

IVD: Total protein IVD, kit, enzyme spectrophotometry

IVD: Triglyceride IVD, kit, enzyme spectrophotometry

IVD: Triglyceride IVD, kit, enzyme spectrophotometry

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

Vk_20230127_24

29.06.2022 

(Updated 28.07.2023)

Meridian Bioscience, Inc.

Revogene
Model: 610210 (Meridian-branded); 130840 (GenePOC-branded)
S/N: All

IVD: NA Integrated Extraction/Amplification/Detection Hardware + accessories + consumables + software

EN-1
EN-2

Vk_20220624_24

27.07.2023

Extrudan Sp. z o.o.

Oxygen Catheters
Model: 3300.0400.10
Lot: 220531/33, 220614/20, 220809/31, 221012/2, 221208/56, 221210/21, 230214/25, 230411/67, 230411/79, 230425/31

MD: Oxygen Therapy Nasal Cannulas

DE-1
FR-1
IT-1

Vk_20230727_03

27.07.2023

B. Braun Melsungen AG

Exadoral syringe
Model: 4608667
Lot: 22N19C8

Injekt syringe
Model: 4606728V, 4606108V
Lot: 22M21C8, 22N08C8, 22N12C8, 22N19C8, 23A02C8, 23A16C8

MD: Metered-delivery hypodermic syringe

MD: Metered-delivery hypodermic syringe

DE-1
FR-1
IT-1

Vk_20230721_01

12.04.2023 

(Updated 27.07.2023)

TRUSETAL VERBANDSTOFFWERK GMBH

TRU-PACK surgical procedure kits
Model: see enclosed list
Lot: see enclosed list

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

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

Vk_20230317_10

18.07.2023 

(Updated 26.07.2023)

GeneProof a.s.

croBEE Real-Time PCR System
SW-Version: 1.0.02

IVD: Nucleic acid sample preparation instrument IVD

DE-1
EN-1

Vk_20230717_09

18.07.2023 

(Updated 26.07.2023)

GeneProof a.s.

myCROBE Fully Automated Instrument
S/N: TR05376, TR05161, TR05381
SW-Version: 1.0.02

IVD: Nucleic acid sample preparation instrument IVD

DE-1
EN-1

Vk_20230717_06

20.07.2023 

(Updated 26.07.2023)

Cook Vascular Incorporated

Lead Clippers
Model: LR-CLP001
Lot: See FSN
SW-Version: N/A

MD: General-purpose surgical scissors, single-use

DE-01
FR-01
IT-01
EN-01

Vk_20230717_01

26.07.2023

EUROSETS S.R.L.

ECMOLIFE ECMO TUBING SET
Model: 14AG70232
Lot: 009208608

MD: Extracorporeal membrane oxygenation system circuit

DE-1
FR-1
IT-1

Vk_20230714_09

11.07.2023 

(Updated 26.07.2023)

Scewo AG

Scewo Bro

MD: Electric Wheelchairs

DE-1
FR-1
EN-1

Vk_20230706_05

25.07.2023

Siemens Medical Solutions USA Inc.

ACUSON Redwood ultrasound system
Model: 11503314

MD: General-purpose ultrasound imaging system

DE-1
IT-1
EN-1

Vk_20230719_01

25.07.2023

Waldemar Link GmbH & Co. KG

MP Monoblock Hip System, Trial Stem
Model: see FSN
Lot: see FSN

MD: Femoral stem prosthesis trial

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

Vk_20230703_14

25.07.2023 

(Updated 25.07.2023)

BioIntegral Surgical, Inc.

BioIntegral Surgical No-React
Model: see FSN
Lot: NR200830 and NR201115

MD: Heart valve bioprosthesis, animal-derived

EN-1

Vk_20220414_23

18.07.2023 

(Updated 24.07.2023)

Smith & Nephew Medical Limited

SECURA No-Sting Skin-Prep/Barrier Film
Model: 59420600, 59420700, 66800712, 66800787, 66800788
Lot: 71430, 71660, 71860, 72090, 72210, 72330, 72780, 73020, , 73030, 73320, 73420, 73600, 73850, 74020, 74240, 74640, , 74890, 75220, 75340, 65630, 65850, 65980, 66210, 66520, , 66670, 72790, 65350, 67340, 67660, 67750, 67770, 67860, 73460, 73820, 66790

MD: Synthetic-polymer liquid barrier dressing, sterile

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

Vk_20230713_20

14.07.2023 

(Updated 24.07.2023)

GE Healthcare Finland Oy

TruSignal AllFit sensor
Model: TS-AF-10; TS-AF-25

TruSignal Ear sensor
Model: TS-E-D; TS-E2-GE; TS-E4-GE; TS-E4-N; TS-E4-H

TruSignal Adult/Pediatric sensor
Model: TS-AP-10; TS-AP-25

TruSignal Sensitive Skin sensor
Model: TS-SE-3

TruSignal Wrap sensor
Model: TS-W-D

MD: Pulse oximeter probe, single-use

MD: Pulse oximeter probe, single-use

MD: Pulse oximeter probe, single-use

MD: Pulse oximeter probe, single-use

MD: Pulse oximeter probe, single-use

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

Vk_20230706_10

18.07.2023 

(Updated 24.07.2023)

Agilent Technologies Singapore Pte Ltd.

FLEX monoclonal Mouse Anti-human MSH2, clone FE11 (ready-to-use)
Model: GA08561-2
Lot: 41484959, 11401467, 11434475, 11463885, 11487459, 11511367, 11538685

FLEX monoclonal Rabbit Anti-human MSH6, clone EP49 (ready-to-use)
Model: GA08661-2
Lot: 41484960, 11412823, 11441903, 11473343, 11502384, 11511369, 11538687

FLEX monoclonal Rabbit Anti-human PMS2, clone EP51 (ready-to-use)
Model: GA08761-2
Lot: 41484961, 11406976, 11434477, 11460770, 11490249, 11511371, 11538689

IVD: MSH2 antigen IVD, antibody

IVD: MSH6 antigen IVD, antibody

IVD: Postmeiotic segregation increased 2 (PMS2) IVD, antibody

DE-1
EN-1

Vk_20230628_12

20.07.2023

Waldemar Link GmbH & Co. KG

MobileLink Acetabular Cup System
Model: 183-610/05
S/N: See FSN

MD: Acetabular shell

DE-1
EN-1

Vk_20230714_23

20.07.2023

Kimetec GmbH

CBC NUCOS
Model: 500580
Lot: 40848/202204 and 41090/202205

MD: Limb tourniquet, manual, reusable

DE-1
FR-1
EN-1

Vk_20230712_23

11.07.2023 

(Updated 20.07.2023)

Quidel Cardiovascular Inc

Triage Cardiac Panel
Model: 97000HS, 97000HSEU, 97000QIL, 97021HS
Lot: See FSN

IVD: Troponin I IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20230710_03

19.07.2023

Cook Endoscopy

Fusion Lithotripsy Extraction Basket
Model: FS-LXB-2X4, FS-LXB-3X6
Lot: See attached 2023FA0007 Global Affected Lots List

MD: Biliary/urinary stone retrieval basket, single-use

DE-1
FR-1
IT-1

Vk_20230630_33

19.07.2023

Ambu A/S

Ambu aView 2 Advance
Model: 405011000
S/N: Version no. 054, 055, 056, 058, , Manufacturing date before 2020-10-30

MD: Endoscopic video image display unit

DE-1
FR-1
IT-1

Vk_20230629_14

05.04.2022 

(Updated 19.07.2023)

Getinge – Maquet GmbH

Advanta V12 Covered Stent System
Model: see FSN
Lot: All
SW-Version: NA

MD: Peripheral artery endovascular stent-graft, non-medicated

DE-2
FR-2
IT-2

Vk_20220308_04

11.07.2023 

(Updated 18.07.2023)

CompuGroup Medical Software GmbH

CGM CLINICAL Medication

MD: Medication calculation software

DE-1
FR-1
IT-1

Vk_20230705_11

18.07.2023

Karl Storz SE und Co. KG

FIVE S 5.3×65, sterile, for single use
Model: 0915612-01, 0915612-06
Lot: all batch numbers with remaining shelf life of the affected model numbers

MD: Flexible video intubation laryngoscope, single-use

DE-1
FR-1
IT-1

Vk_20230705_09

10.07.2023 

(Updated 18.07.2023)

Ortho Clinical Diagnostics

ORTHO VISION Analyser
Model: 6904579

ORTHO VISION Max Analyser
Model: 6904578

IVD: Blood group/antibody screening analyser IVD

IVD: Immunohaematology/blood bank analyser IVD

DE-1
FR-2

Vk_20230628_03

21.03.2023 

(Updated 18.07.2023)

Draeger Medical Systems, Inc.

Infinity Central Station
Model: MS26800
SW-Version: VG3.0.1 and lower

Infinity M300/M300+
Model: MS18501, MS33950
SW-Version: VG2.4 and lower

MD: Centralized patient monitor

MD: Centralized patient monitor

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

Vk_20230320_03

11.07.2023 

(Updated 17.07.2023)

Beckman Coulter , Inc.

Access TSH (3rd IS) reagent pack
Model: B63284
Lot: see FSN

Access Folate (Reagent Pack)
Model: A98032
Lot: see FSN

IVD: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IVD: Folate (vitamin B9) IVD, reagent

DE-1
EN-1

Vk_20230705_05

06.10.2021 

(Updated 14.07.2023)

Siemens Healthcare Diagnostics Inc

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

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

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Chemiluminescent immunoassay analyser IVD

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

Vk_20210928_28

11.07.2023 

(Updated 12.07.2023)

Olympus Medical Systems Corp.

PowerSpiral Intestinal Videoscope PSF-1
Model: PSF-1; N5788540, N5788550
S/N: All

MD: Flexible video enteroscope

DE-1
FR-1
EN-1

Vk_20230704_23

11.07.2023

Philips Medizinsysteme Böblingen GmbH

IntelliVue MX400-550
Model: 866060, 866062, 866064, 866066
SW-Version: P.01.01

MD: Multiple vital physiological parameter monitoring system, clinical

EN-1

Vk_20230710_16

11.07.2023

DiaSys Diagnostic Systems GmbH

CRP FS
Model: 1 7002
Lot: see FSN

IVD: C-Reactive Protein IC RT/POC => 12.70.11.01

EN-1

Vk_20230710_12

11.07.2023

Alcon Laboratories, Inc.

Phaco tips and procedure packs containing phaco tips
Model: See FSN

MD: Phacoemulsification system handpiece tip, single-use

DE-1
FR-1
IT-1

Vk_20230707_12

04.07.2023 

(Updated 11.07.2023)

Randox Laboratories Ltd

Liquid Urine Control Level 2
Model: UC5074
Lot: 1209UC

IVD: Multiple urine analyte IVD, control

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

Vk_20230703_20

05.12.2022 

(Updated 11.07.2023)

Philips Electronics Nederland B.V.

Philips Ingenia Elition
Model: 781357, 782106, 782137, 781358, 782107, 782119, 782136
S/N: see FSN

MD: Full-body MRI system, superconducting magnet

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

Vk_20221123_04

10.07.2023

Philips Medical Systems Nederland B.V

Philips Allura Xper
S/N: 459800772231, 459800772233, 459800772261, 459800772263, 459800415531, 459800415532, 459800415533, 459800415534, 459800415535, 459800415571, 459800415572, 459800415573, 459800415574, 459800415575

Philips Azurion system
S/N: 459800772231, 459800772233, 459800772261, 459800772263, 459800415531, 459800415532, 459800415533, 459800415534, 459800415535, 459800415571, 459800415572, 459800415573, 459800415574, 459800415575

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

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

DE-1
FR-1
IT-1

Vk_20230628_02

07.07.2023

Aesculap AG

MINOP TROCAR outer diameter 6 mm 4 channels
Model: FF399R
Lot: see FSN
S/N: see FSN

MD: Laparoscopic access cannula, reusable

DE-1
FR-1
EN-1

Vk_20230703_11

07.07.2023

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.16.02.03

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20230628_17

07.07.2023

Covidien llc

Mahurkar Acute High Pressure Triple Lumen Catheters
Model: 8888345611HP; 8888345637HP
Lot: 2113300288, 2203300175, 2021000109; 2102600094

Mahurkar Acute Triple Lumen Catheters
Model: 8888340629
Lot: 1921300069

MD: Triple-lumen haemodialysis catheter

MD: Triple-lumen haemodialysis catheter

DE-1
EN-1

Vk_20230628_16

07.07.2023

iMDsoft Ltd

MetaVision
Model: MetaVision 6; 6.20, 6.18, 6.17, 6.16, 6.15, 6.14, 6.12, 6.11, 6.10, 6.9, 6.8, 6.7, 6.0

MD: Patient health record information system application software

IT-1
EN-1

Vk_20230623_26

05.07.2023

BD Switzerland Sàrl

Alaris Gateway Workstation (AGW)
Model: see FSN

MD: Infusion pump management unit, mobile

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

Vk_20230626_21

05.07.2023

Datex-Ohmeda Inc.

Giraffe OmniBed Carestation
Model: 2082844-001-XXX
S/N: all

MD: Conventional infant incubator

DE-1
FR-1
IT-1

Vk_20230626_09

04.07.2023

Drägerwerk AG & Co. KGaA

Carina
Model: 5704110
S/N: All

MD: Neonatal/adult intensive-care ventilator

DE-1
FR-1
IT-1

Vk_20230703_04

04.07.2023

GE Medical Systems Israel Ltd.

Vivid S60, Vivid S70
SW-Version: v203, v204, v205, v206

MD: Cardiovascular ultrasound imaging system

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

Vk_20230628_10

03.07.2023 

(Updated 04.07.2023)

HOYA Medical Singapore Pte.Ltd.

Vivinex multiSert IOL
Model: XY1-SP, XC1-SP

MD: Iols, Aphakic

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

Vk_20230616_03

20.06.2023 

(Updated 04.07.2023)

EVOLUTIS SAS

Reusable intruments
Model: see FSN
Lot: All batch

MD: reusable instruments

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

Vk_20230616_01

16.01.2023 

(Updated 04.07.2023)

SD Biosensor Inc.

STANDARD F C.difficile Toxin A/B FIA
Model: 10CDT10D
Lot: 6082CX1AC

IVD: C.difficile Toxin A/b Detection

DE-1
DE-2

Vk_20230103_05

28.06.2023 

(Updated 03.07.2023)

Vygon

Kocher forceps in delivery sets
Model: See FSN

MD: Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

FR-1
EN-1

Vk_20230627_28

03.07.2023

Integra LifeSciences Corp

Codman Cranial Access Kit without drugs
Model: 82-6617
Lot: All unexpired lots

MD: Intracerebral cannula, nonimplantable, reusable

DE-1
FR-1
IT-1

Vk_20230619_11

02.06.2023 

(Updated 03.07.2023)

Medline International France SAS

Turkuaz Ultrasound Gel included in Medline Sterile Procedure Trays
Model: Gel: 126590; Kit: ZGZAN012B, ZGZBA133E, ZGZBA152A, ZGZBA174A, ZGZCV010E, ZGZMA073A
Lot: all

Turkuaz Sterile Ultrasound Gel included in Medline Probe Covers Kit
Model: Gel: 126590; Kit: ICE5900, ICE5910, ICE5920, ICE5930
Lot: all

MD: Topical coupling gel, sterile

MD: Topical coupling gel, sterile

DE-1-OP
DE-2-MS
FR-1-OP
FR-2-MS
EN-1-OP
EN-2-MS

Vk_20230522_43