Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2021 – 30.09.2021

09.2021 

(Updated 05.10.2021)

Cook Incorporated

Flexor Check-Flo Introducer
Model: KCFW-6.0-35-45-RB
Lot: 13861362

MD: Vascular catheter introduction set, nonimplantable

DE-1
EN-1

Vk_20210924_05

04.08.2021 

(Updated 05.10.2021)

Welch Allyn Inc

Braun ThermoScan PRO 6000
Model: All
S/N: All

MD: Infrared patient thermometer, ear

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

Vk_20210728_05

04.10.2021

Schiller AG

FRED Easyport
Model: 0.900000
S/N: see list attached to the FSN
SW-Version: 03.14B6

MD: Non-rechargeable public semi-automated external defibrillator

DE-1
IT-1
EN-1

Vk_20210928_09

21.09.2021 

(Updated 04.10.2021)

Ophtec BV

Artiflex
Model: 40114SW, 4A0**SW, 4C0**SW

Artisan
Model: 130**1W, 140**1W, 203001W, 204001W, 206001W

MD: Anterior-chamber intraocular lens, phakic

MD: Anterior-chamber intraocular lens, phakic

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

Vk_20210920_10

01.10.2021

ZOLL Circulation

Cool Line Catheter CL-2295 AE
Model: 8700-0781-40 (model: CL-2259AE)

Quattro IVTM Catheter
Model: 8700-0783-40 (MODEL: IC-4593AE)

Solex 7 Catheter
Model: 8700-0793-40 (model: SL-2593AE)

ZOLL IVTM ICY Catheter
Model: 8700-0782-40 (model: IC-3893-AE)

MD: Intravascular heating/cooling system catheter

MD: Intravascular heating/cooling system catheter

MD: Intravascular heating/cooling system catheter

MD: Intravascular heating/cooling system catheter

DE-1
FR-1
IT-1

Vk_20210927_13

29.09.2021

VIRCELL

TETANUS VIRCLIA IgG MONOTEST
Model: VCM004
Lot: 21C004002

IVD: Tetanus (Clostridium T.)

EN-1

Vk_20210924_23

21.09.2021 

(Updated 29.09.2021)

Medtronic Inc.

Activa Clinician Programmer Application
Model: A610
Lot: n/a
S/N: all
SW-Version: 3.0.1048, 3.0.1057 and 3.0.1062

AIMD: Multiple active implantable device programmer

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

Vk_20210916_11

28.09.2021

MEDTECH

ROSA One
Model: ROSAS00201 (model: ROSA One 3.1 Brain Application)
SW-Version: 3.1.3.1494 and following versions

MD: Multi-purpose stereotactic surgery system

FR-1

Vk_20210924_07

28.09.2021

ResMed Ltd.

AcuCare hospital full face masks
Model: F1-0, F1-1, F1-4.; 60759, 60760, 60761, 60786, 60787, 60788, 60762, 60763, 60764, 60789, 60790, 60791, 60765, 60766, 60767, 60792, 60793, 60794.
Lot: All
S/N: N/A
SW-Version: N/A

MD: CPAP/BPAP face mask, single-use

DE-1
FR-1
IT-1

Vk_20210922_16

08.09.2021 

(Updated 27.09.2021)

Agilent Technologies Singapore Pte Ltd.

EnVision FLEX Hematoxylin (Link)
Model: K8008
Lot: 41246596

IVD: Biological stain IVD

FR-1
EN-1

Vk_20210903_21

21.09.2021 

(Updated 24.09.2021)

Advanced Surgical Concepts Ltd.

PneumoLiner
Model: WA90500A
Lot: 649135

MD: Trocars, Abdominal; Cavity Liners

DE-1
EN-1

Vk_20210921_01

17.09.2021 

(Updated 24.09.2021)

Datascope Corp.

Cardiosave Hybrid/Rescue IABP
Model: 0998-XX-0800-XX
Lot: All
S/N: All Cardiosave serial numbers distributed since March 6, 2012 to present and ongoing.

MD: Intra-aortic balloon pump

DE-1
FR-1
IT-1

Vk_20210913_06

08.09.2021 

(Updated 24.09.2021)

DJO, LLC

CHATTANOOGA ultrasound gel and lotions
Model: 4238, 4248, 4266, 4262, 4260, 4210, 4208
Lot: all
S/N: all

MD: Coupling gel, non-sterile

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

Vk_20210830_19

14.09.2021 

(Updated 23.09.2021)

RaySearch Laboratories AB (publ)

RayStation
Model: RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A and Service packs
Lot: see FSN
S/N: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.

MD: Radiation therapy software

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

Vk_20210913_19

21.09.2021 

(Updated 23.09.2021)

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
FR-1
IT-1
EN-1

Vk_20210906_17

22.09.2021

Herdegen SAS

Advance
Model: 200913, 205917, 205917
Lot: see FSN

EVOLUTION, FUN
Model: 200000, 200017
Lot: see FSN

MD: Elbow crutch

MD: Elbow crutch

FR-1
EN-1

Vk_20210916_07

21.09.2021

William Cook Europe ApS

Inferior Vena Cava (IVC) Filter
Model: See attached list
Lot: All lot numbers

MD: Vena cava filter, temporary/permanent

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

Vk_20210915_11

21.09.2021

Elekta Limited

Linear Accelerator
Lot: All Digital Linear Accelerators

MD: Linear accelerator system

DE-1
FR-1
EN-1

Vk_20210915_10

20.09.2021

William A. Cook Australia Pty Ltd.

Single Lumen and Double Lumen Ovum Pick-Up Needles
Model: See FSN

MD: Body aspiration needle, single-use

DE-1
FR-1
IT-1

Vk_20210908_21

01.09.2021 

(Updated 15.09.2021)

MAQUET Cardiopulmonary GmbH

HCU40
Model: 70104.4054; 70105.4917; see model number
Lot: N/A
S/N: all serial numbers since production start
SW-Version: N/A

MD: Cardiopulmonary bypass system heat exchanger, reusable

DE-1
FR-1
EN-1

Vk_20210825_03

14.09.2021

bioMerieux Inc

MYLA
Model: 423270 ; 423434
SW-Version: V4.7 ; V4.7.1 ; V4.8 ; V4.8.1 ; V4.8.2

IVD: Laboratory instrument/analyser application software IVD

EN-1

Vk_20210913_16

14.09.2021

Philips Medical Systems

Infant/Child SMART Pads Cartridge
Model: M5072A
Lot: Y111220-01

MD: External defibrillator electrode, paediatric, single-use

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

Vk_20210909_05

14.09.2021

Atrium Medical Corporation

Atrium Pneumostat Chest Drain Valve
Model: 16100
Lot: All-see attachment

MD: Closed-wound/centesis drainage receptacle

DE-1
FR-1

Vk_20210901_05

13.09.2021

Inpeco S.A.

Aptio Automation

IVD: Specimen processing instrument IVD, automated

DE-1
FR-1
IT-1

Vk_20210913_09

06.09.2021 

(Updated 13.09.2021)

Abbott Molecular Inc.

Alinity m Resp-4-Plex Amplification Reagent Kit
Model: 09N79-090

Alinity m SARS-CoV-2 Amplification Reagent Kit
Model: 09N78-090; 09N78-091

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

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

DE-1
FR-1
EN-1

Vk_20210906_01

13.09.2021

Laboratoire CCD

1ml IVF and AI Syringes
Model: 1323101

MD: General-purpose syringe, single-use

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

Vk_20210903_28

10.09.2021

GE Healthcare

Centricity Universal Viewer

MD: Medical image management system

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

Vk_20210903_26

07.09.2021 

(Updated 10.09.2021)

Thermo Fisher Scientific Microbiology Basingstoke

ThermoScientificTM OxoidTM Egg Yolk Emulsion
Model: SR0047C
Lot: 3281762

IVD: Culture medium supplement, enriched

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

Vk_20210901_11

25.08.2021 

(Updated 10.09.2021)

Chalice Medical Ltd

Paratherm
Model: 54-00-16, 54-00-18
S/N: All Serial Numbers

MD: Extracorporeal cardiopulmonary support system heating/cooling unit

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

Vk_20210820_20

08.09.2021 

(Updated 10.09.2021)

Roche Diagnostics GmbH

TDM parameters on cobas c 503 analytical unit
Model: VANC3 (08445605190, 08058849190), GENT2 (08057770190), PHNY2 (08445567190, 08058601190), THEO2 (08253153190), PHNO2 (08058580190)
Lot: all

IVD: Multi-modality clinical specimen analysis system IVD

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

Vk_20201127_04

08.09.2021

Datex-Ohmeda, Inc (GE Healthcare)

Flow Sensors used in the GEHC anesthesia machines
Model: See FSN

MD: Anaesthesia workstation, general-purpose

DE-1
FR-1
IT-1

Vk_20210901_10

08.09.2021

Medtronic Xomed

Sterile Blade Single-Use Accessories
Model: See FSN
Lot: See FSN

MD: Orthopaedic bur, single-use

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

Vk_20210831_19

02.09.2021

Baxter Healthcare SA

PrisMax, V2, ROW
Model: 955558
S/N: 100339, 100626, 104907, 104945, 105380, 106984

PrisMax V2 TO PrisMax V3 UPGRADE KIT
Model: SC8010
S/N: A2210003

MD: Haemodialysis system, institutional

MD: Haemodialysis system, institutional

DE-1
FR-1

Vk_20210826_12

17.08.2021 

(Updated 02.09.2021)

HeartWare Inc.

HeartWare Ventricular Assist System – HVAD Pump Implant Kit
Model: 1102, 1104, 1205, MCS1705PU
S/N: HW1110, HW1173, HW1475, HW1542, HW1798, HW271, HW472, HW544, HW1319, HW20280, HW20446, HW20870, HW20916, HW20918, HW21216, HW2496, HW29329, HW32470, HW32520, HW34806, HW35284, HW35644, HW1857
SW-Version: n/a

AIMD: Implantable ventricular circulatory assist system

DE-1_other
DE-1_repaired
FR-1
EN-1_other
EN-1_repaired

Vk_20210816_15

23.08.2021 

(Updated 02.09.2021)

Beckman Coulter , Inc.

Access hsTnI Reagent (High Sensitivity Troponin I)
Model: B52699
Lot: All

IVD: Troponin I IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
EN-1

Vk_20210809_09

01.09.2021

SEBIA

CAPI 3 IMMUNOTYPING
Model: 2600
Lot: 11021/01 -11021/02

IVD: Multiple clinical chemistry protein IVD, reagent

DE-1
FR-1
EN-1

Vk_20210830_09

01.09.2021

Chromsystems Instruments & Chemicals GmbH

96 Deep Well Filter Plates of MassTox Immunosuppressants in whole blood – ONEMINUTE Test
Model: 93957
Lot: 1120, 0121

IVD: Microplate IVD

DE-1

Vk_20210830_02

01.09.2021

Roche Diagnostics GmbH

cobas EGFR Mutation Test, v2 IVD
Model: 07248563190

IVD: Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

EN-1

Vk_20210827_15

31.08.2021 

(Updated 01.09.2021)

Dräger Medical GmbH

Atlan
Model: A300 (8621300), A300XL (8621400), A350 (8621500), A350XL (8621600)
SW-Version: 1.01

MD: Anesthesia Units

DE-1
FR-1
IT-1

Vk_20210827_10

01.09.2021

Medtronic Inc.

DLP Left Heart Vent
Model: 12116, 12118
Lot: All
S/N: n/a

MD: Cardiopulmonary bypass cannula, arterial

DE-1
EN-1

Vk_20210824_08

31.08.2021

W. L. Gore & Associates

GORE CARDIOFORM Septal Occluder
Model: GSXE0020, GSXE0025, GSXE0030
S/N: Starting with 22689696 and ending with 23569078

MD: Cardiac occluder

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

Vk_20210831_04

31.08.2021

Drägerwerk AG & Co.KGaA

Babylog VN500
SW-Version: 2.60 and lower

Evita
Model: V300, V500
SW-Version: 2.60 and lower

MD: Neonatal/adult intensive-care ventilator

MD: Ventilators, Intensive Care

DE-1
FR-1
IT-1

Vk_20210827_07

31.08.2021

GE Healthcare

Centricity PACS-IW with Universal Viewer
Model: see FSN
Lot: see FSN

MD: Medical image management system

DE-1
FR-1
IT-1

Vk_20210826_24

31.08.2021

Philips Medical Systems Nederland BV

Ingenia & SmartPath to dStream MRI
Model: 781341, 781396, 781315, 781347, 781261, 781262, 781260, 781359, 781342, 781377, 781357, 781358, 781271, 781270, 781356
S/N: see FSN

MD: Full-body MRI system, superconducting magnet

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

Vk_20210824_10

27.08.2021 

(Updated 30.08.2021)

CAIR LGL

Polyurethane enteral feeding tubes
Model: NCE…PU, NCE…AU, NCE…G

MD: Nasogastric/orogastric tube

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

Vk_20210811_01

10.08.2021 

(Updated 27.08.2021)

GS Elektromedizinische Geräte G. Stemple GmbH

corpuls3
Model: 04301
S/N: See FSN

corpuls3 Touch
Model: 04302
S/N: See FSN

MD: Physiologic-monitoring defibrillation system

MD: Physiologic-monitoring defibrillation system

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

Vk_20210804_25

08.06.2021 

(Updated 27.08.2021)

Medtronic Inc.

LINQ II Insertable Cardiac Monitor
Model: LNQ22
Lot: all

AIMD: Implantable cardiac monitor

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

Vk_20210602_17

26.08.2021

Caesarea Medical Electronics Limited

BodyGuard Infusion Pumps Systems (LVP)
Model: see FSN
Lot: see FSN

MD: Multichannel general-purpose infusion pump

DE-1
FR-1
EN-1

Vk_20210823_05

25.08.2021

Siemens Healthcare GmbH

syngo.via RT Image Suite
SW-Version: see FSN

MD: CT system application software

DE-1 (CT042)
DE-1 (SY052)
FR-1 (CT042)
FR-1 (SY052)
IT-1 (SY052)

Vk_20210820_22

25.08.2021

A.M.I. Agency for Medical Innovations GmbH

i-Cut
Model: ICT5011
Lot: 210166; 191878; 200319; 201885; 201944; 210153

MD: Tissue morcellation system handpiece, line-powered

DE-1
EN-1

Vk_20210820_15

25.08.2021

Karl Storz SE & Co.KG

FIVE S 3, 5×65, steril zum Einmalgebrauch
Model: 091361-06
Lot: All LOTs with remaining shelf life
S/N: n/a
SW-Version: n/a

MD: Flexible video intubation laryngoscope, single-use

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

Vk_20210817_13

24.08.2021

Medline Industries Inc.

Namic Sterile Stopcock and Manifolds
Model: see FSN
Lot: see FSN

MD: Stopcock

DE-1
FR-1
EN-1

Vk_20210819_18

23.08.2021

Henry Schein Inc.

Peripheral venous catheter set with and without safety
Model: see FSN

MD: Winged needle infusion set, I.V. catheter with port and with and without wings, Obturator

DE-1

Vk_20210811_05

20.08.2021

Hillrom

OctoStretch with Stretch Leveler
Model: 3156056

FlexoStretch
Model: 3156057

Stretch Leveller
Model: 3156200

LikoStretch 1900
Model: 3156051

LikoStretch Mod 600 IC
Model: 3156065

MD: Patient lifting system stretcher

MD: Patient lifting system stretcher

MD: Accessory

MD: Patient lifting system stretcher

MD: Patient lifting system stretcher

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

Vk_20210810_12

19.08.2021 

(Updated 20.08.2021)

Laboratoires ANIOS (ECOLAB)

Module Endoscopique HDAI and HDE

MD: sink

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

Vk_20210803_15

19.08.2021

CareFusion

Illinois Bone Marrow Aspiration/ Intraosseous Needle, 15G x 79mm
Model: TIN3015
Lot: all lots

MD: Bone marrow biopsy needle, single-use

DE-1
EN-1

Vk_20210812_19

13.07.2021 

(Updated 19.08.2021)

Xstrahl Ltd

Xstrahl
Model: X150
S/N: serial numbers GM0055 (2002) to GM0533 (2020).

MD: Stationary orthovoltage therapeutic x-ray system

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

Vk_20210709_01

24.06.2021 

(Updated 19.08.2021)

Fritz Stephan GmbH

Eve In
Model: 107061410, 107061411

Eve Tr
Model: 107061400, 107061401

Eve Neo
Model: 107061420, 107061421

MD: Adult And Paediatric/neonatal Pulmonary Ventilators

MD: Adult And Paediatric/neonatal Pulmonary Ventilators

MD: Adult And Paediatric/neonatal Pulmonary Ventilators

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

Vk_20210617_18

18.08.2021

Beckman Coulter Biomedical GmbH

DxA 5000
Model: DxA 5000; DxA 5000 (B87352) with B57634
Lot: Not applicable
S/N: All DxA Systems with B57634
SW-Version: All DxA Systems with B57634

IVD: Automated sample handling system

DE-1
EN-1

Vk_20210811_14

18.08.2021

Thermofisher Scientific

RapID NF PLUS System
Model: R8311005
Lot: 158548, 143096, 158586, 168222, 168235

IVD: Bacteria identification

DE-1
EN-1

Vk_20210811_09

25.06.2021 

(Updated 18.08.2021)

G. Heinemann Medizintechnik GmbH

MODULA

MD: ENT cabinet

DE-1
FR-1
IT-1

Vk_20210615_21

17.08.2021

HOYA Corp.

PENTAX Video Duodenoscope
Model: ED34-i10T2
S/N: All

MD: Flexible video duodenoscope, reusable

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

Vk_20210812_20

03.08.2021 

(Updated 16.08.2021)

SSI Diagnostica A/S

Immuview S. pneumoniae and L. pneumophila urinary antigen test
Model: 95389
Lot: PL20210526
S/N: –
SW-Version: n/a

IVD: Bacteriology (Infect. Immunology)

DE-1
EN-1

Vk_20210729_21

26.07.2021 

(Updated 16.08.2021)

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

Vk_20210712_10

13.08.2021

Disposan AG

Saliva Ersatz Kit Disposan
Model: T 4005
Lot: see FSN

IVD: Sampling Kits

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

Vk_20210813_14

13.08.2021

Brightwake Limited

Activon Tube
Model: CR3830
Lot: WO028513, WO028510

Algivon Honey Dressing
Model: CR3831, CR3659
Lot: WO027891, WO027894

MD: Wound-nonadherent dressing, permeable, antimicrobial

MD: Wound-nonadherent dressing, permeable, antimicrobial

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

Vk_20210810_19

06.02.2019 

(Updated 12.08.2021)

Philips Medical Systems

Philips PageWriter TC Cardiographs (TC20/30/50/70)
Model: TC20/30/50/70
Lot: NA
SW-Version: All with software revisions up to and including A.07.05.22.

MD: Electrocardiograph, professional, multichannel

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

Vk_20190123_09

11.08.2021

Philips Medical Systems DMC GmbH

CombiDiagnost R90
Model: 709030
SW-Version: R1.0 / R1.1

MD: Radiographic/fluoroscopic unit, mobile

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

Vk_20210809_08

11.08.2021

Philips Medical Systems DMC GmbH

CombiDiagnost R90 R1.1, Upgrades for CombiDiagnost R90
Model: 709031 and 709130
SW-Version: R1.1.1 / R1.1.2

MD: Radiographic/fluoroscopic unit, mobile

FR-1
IT-1
EN-1

Vk_20210809_07

11.08.2021

Elekta, Inc.

Monaco RTP System
SW-Version: Version 5.40.00, 5.40.01, 5.40.02, 5.51.10

MD: Radiation therapy software

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

Vk_20210806_10

11.08.2021

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_20210805_03

03.08.2021 

(Updated 11.08.2021)

Olympus Medical Systems Corp.

Forceps/Irrigation Plug (Isolated Type)
Model: MAJ-891; N6149350, 028537, A02917A
Lot: all LOT numbers distributed within the last 3 years (since 01.07.2018)

MD: Endoscopic procedure air/water valve, reusable

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

Vk_20210729_25

11.08.2021

Promedon S.A.

Metal semi rigid injection needle
Model: 3, 6 Fr metal semi rigid injection needle facette tip; RINS
Lot: EST0000598
S/N: 5000119

MD: Submucosal injection needle

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

Vk_20210726_18

10.08.2021

Altomed Limited

Damato Ruthenium Plaque Template
Model: A7078
Lot: 00702

MD: Eye brachytherapy plaque-/applicator-positioning template

EN-1

Vk_20210805_11

10.08.2021

bioMérieux SA

VIDAS EBV VCA IGM
Model: 30237
Lot: 1008591990
S/N: N/A
SW-Version: N/A

IVD: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20210803_04

10.08.2021

Fresenius Kabi Deutschland GmbH

Exelia Combox
Model: Z086710
S/N: all

Exelia Therapy Manager
Model: Z086810
S/N: all

Exelia VP
Model: Z085010
S/N: all

MD: Syringe pump

MD: Infusion pump management unit, mobile

MD: General-purpose infusion pump, line-powered

FR-1

Vk_20210802_04

10.08.2021

Verathon Medical Inc.

GlideScope Go Monitor
Model: 0570-0368; 0570-0366
S/N: See FSN

MD: handheld video monitor

DE-1

Vk_20210729_09

10.08.2021 

(Updated 10.08.2021)

HS Doms GmbH

HSM 600
Model: 3320087, 3320088, 3320089, 3320090

MD: Tables, Instrument

DE-1
FR-1
IT-1

Vk_20210727_14

15.07.2021 

(Updated 10.08.2021)

Nobel Biocare AB

Full Contour Zirconia (FCZ) Implant Crown
Model: 77352, 77363, 77387, 77339, 77364
Lot: 173939852, 173940027, 173940107, 173940346, 173940844, 173940845, 173940852, 173942662, 173942675, 173943674, 173943711, 173943753
S/N: 173939852, 173940027, 173940107, 173940346, 173940844, 173940845, 173940852, 173942662, 173942675, 173943674, 173943711, 173943753
SW-Version: N/A

MD: Dental implant suprastructure, permanent, preformed

FR-1
EN-1

Vk_20210623_02

04.08.2021 

(Updated 09.08.2021)

Abbott Laboratories

Alinity ci-series System Control Module
Model: 03R70-01
S/N: see FSN
SW-Version: 3.2.0, 3.2.1, 3.2.3

IVD: Chemiluminescent immunoassay analyser IVD, automated

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

Vk_20210729_15

10.03.2021 

(Updated 09.08.2021)

B. Braun Surgical, S.A.

HISTOACRYL BLUE/ LAPFIX/PROSET OFX
Model: 1050044; 1050052; 1050165; 1052008; 1052007; 1051007
Lot: see FSN

MD: Surgical adhesive/sealant, synthetic polymer

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

Vk_20210304_05

27.07.2021 

(Updated 05.08.2021)

HemoSonics, LLC

Qplus Cartridges
Model: KT-0010
Lot: 3000000028

IVD: Other Haemostasis RT & POC

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

Vk_20210722_23

24.03.2021 

(Updated 05.08.2021)

Medtronic Inc.

Activa Clinician Programmer Application
Model: A610
S/N: All
SW-Version: 2.0.4584, 2.0.4594, 2.0.4605, 3.0.1057

AIMD: Multiple active implantable device programmer

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

Vk_20210316_15

04.08.2021

Leica Biosystems Newcastle Ltd

BOND Ready-to-Use Primary Antibody CDX2 (EP25)
Model: PA0375
Lot: 69909

IVD: Homeobox protein CDX-2 IVD, antibody

DE-1
FR-1
IT-1

Vk_20210802_14

04.08.2021

Dräger Medical AG & Co. KGaA

Zeus Infinity Empowered
Model: MK04000
SW-Version: 2.02

MD: Anaesthesia unit

DE-1
FR-1
IT-1

Vk_20210730_04

04.08.2021

SEBIA

CAPI 3 IMMUNOTYPING
Model: 2600
Lot: 04021/01 – 04021/02

IVD: Immunotyping

EN-1

Vk_20210729_02

12.05.2021 

(Updated 04.08.2021)

RaySearch Laboratories AB (publ)

RayStation
Model: See FSN

MD: Radiation therapy software

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

Vk_20210510_35

08.10.2019 

(Updated 04.08.2021)

Elekta, Inc.

Monaco RTP System
SW-Version: 5.40, 5.50, 5.51

MD: Radiation therapy software

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

Vk_20191001_12

03.08.2021

Respironics, Inc

Trilogy Evo
Model: see FSN
SW-Version: see FSN

Trilogy Evo O2
Model: see FSN
SW-Version: see FSN

Trilogy EV300
Model: see FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

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

Vk_20210803_11

03.08.2021

Biocompatibles UK Ltd. (a subsidiary of Boston Scientific Corporation)

TheraSphere Administration Sets
Model: See FSN
Lot: See FSN

AIMD: Manual-afterloading brachytherapy system source delivery procedure kit

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

Vk_20210730_05

27.07.2021 

(Updated 03.08.2021)

Normand-Info S.A.S.U subsidiary of Beckman Coulter International S.A.

Remisol Advance
Model: see FSN
Lot: Not applicable
S/N: Not applicable
SW-Version: Version 2.0 and 2.1

IVD: Clinical laboratory information system application software

DE-1
FR-1

Vk_20210727_02

03.08.2021

William A. Cook Australia Pty Ltd

MINC MINI INCUBATOR
Model: K-MINC-1000; G20079
Lot: see FSN
S/N: see FSN
SW-Version: N/A

MD: Carbon dioxide laboratory incubator

DE-1
FR-1
IT-1

Vk_20210723_20

27.07.2021 

(Updated 03.08.2021)

BD Switzerland Sàrl

SmartSite Needle Free Valve
Model: 2000E7D
Lot: 1016762, 1017152, 1018579, 1019886

MD: Negative-Pressure Needleless Valve Connector, Extension sets & gravity sets, Intravenous Fluid Bag Spike, Electric infusion pump administration set, single-use

DE-2
EN-1
EN-2

Vk_20210629_13

02.06.2021 

(Updated 03.08.2021)

bioMérieux SA

VIDAS Anti-HBs Total II
Model: 30318
Lot: See FSN

IVD: Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)

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

Vk_20210528_12

02.08.2021

Micro Therapeutics, Inc.

Pipeline Flex Embolization Device & Pipeline Flex with Shield Technology
Model: see FSN
Lot: see FSN

MD: Bare-metal intracranial vascular stent

DE-1
FR-1
EN-1

Vk_20210722_24

26.07.2021 

(Updated 02.08.2021)

Roche Diabetes Care GmbH

Accu-Chek Aviva, Performa and Inform II test strip
Lot: All non-expired lot numbers

IVD: Glucose IVD, reagent

DE-1_DIST
DE-1_HCP
DE-1_INFORM
DE-1_PATIENT
FR-1_DIST
FR-1_HCP
FR-1_INFORM
FR-1_PATIENT
IT-1_DIST
IT-1_HCP
IT-1_INFORM
IT-1_PATIENT
EN-1_DIST
EN-1_HCP
EN-1_PATIENT

Vk_20210720_16

02.08.2021

Edwards Lifesciences LLC

PediaSat Oximetry Catheter
Model: XT3515SP; XT358SP
Lot: 62420335, 62452820, 62661574, 62685549, 62704126, 62728568, 62728569, 63677093, 63677094, 62685542, 62704123, 63608316, 63316354, 62836958, 62836959

MD: Oximeter catheter, single-use

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

Vk_20210716_25

23.06.2021 

(Updated 02.08.2021)

HeartWare Inc.

HeartWare Ventricular Assist System (HVAD)
Model: 1104
S/N: All

AIMD: Implantable ventricular circulatory assist system

DE-1
DE-2
FR-1

Vk_20210603_18

29.07.2021

PROCEPT BioRobotics Corporation

AQUABEAM Handpiece
Model: HP2000
Lot: 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, 21C00527
SW-Version: N/A

MD: Water jet knife system handpiece, single-use

DE-1
FR-1
EN-1

Vk_20210721_22

27.07.2021 

(Updated 28.07.2021)

Cordis Cashel

SABER PTA Dilatation Catheter
Model: 48004010X
Lot: 82219442

MD: Peripheral angioplasty balloon catheter, basic

DE-1
EN-1

Vk_20210727_01

27.07.2021

Wassenburg Medical B.V.

WASSENBURG WD4200 washer-disinfector
S/N: all

MD: Endoscope washer/disinfector

DE-1
FR-1
EN-1

Vk_20210723_05

27.07.2021 

(Updated 27.07.2021)

Ethicon Endo-Surgery LLC

Harmonic HD 1000i Shears
Model: see FSN
Lot: see FSN

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

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

Vk_20210719_28

20.07.2021 

(Updated 27.07.2021)

DiaMed GmbH

NA
Model: 50380; 008610
Lot: 50380 29 01

IVD: Column agglutination IVD

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

Vk_20210716_01

27.07.2021

W. L. Gore & Associates

GORE Molding and Occlusion Balloon Catheter
Model: MOB37
S/N: between 22982051 and 23516741

MD: Peripheral angioplasty balloon catheter, basic

DE-1
FR-1
IT-1

Vk_20210712_30

26.07.2021

Stryker Medical

LIFEPAK 15 KEYPAD ASSY-MAIN CONTROL
Model: V15-2-XXXXXX
Lot: See FSN

MD: LIFEPAK 15 Keypad

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

Vk_20210721_21

01.06.2021 

(Updated 26.07.2021)

ADRIA S.R.L.

B. Needle
Model: COW 2015
Lot: AD0400/20, AD0677/20

Vertebroplasty
Model: T060430, T060431, T060435, 49225
Lot: AD0109/20, ZU0214, ZU0377, ZV0227, AD0614/20, ZU0168, ZV0262, AD0208/20, ZU0475, ZV0697

Kit of Cement Injection cannulas
Model: 495041123
Lot: ZU0146, ZV0500

MD: Needles for biopsy

MD: Vertebroplasty needles for the infusion of cements

MD: Kit of Cement Injection cannulas for kyphoplasty

DE-1
DE-2
FR-1
FR-2
IT-1
EN-/IT-2
EN-1
EN-product list

Vk_20210527_16

20.07.2021 

(Updated 23.07.2021)

Olympus Medical Systems Corp.

GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500
Model: N6129030, N6129050
S/N: all

COLONOVIDEOSCOPE CF-EZ1500DI
Model: N6022430, N6022450
S/N: all

COLONOVIDEOSCOPE CF-EZ1500DL
Model: N6022530, N6022550
S/N: all

EVIS X1 VIDEO SYSTEM CENTER CV-1500
Model: N6011250
S/N: The third digit of the affected serial number is “0” or “1” as follows; 7#0####, 7#1#### and a part of 7#2#### (Software version before version 2.0)

MD: Flexible video gastroduodenoscope

MD: Flexible video colonoscope, reusable

MD: Flexible video colonoscope, reusable

MD: Endoscopic video image processing/light source system

DE-1
FR-1
EN-1

Vk_20210716_24

21.07.2021 

(Updated 23.07.2021)

Suzhou Yuno Biotechnology Co. Ltd; Tai Zhou Sun Trine Biotechnology Co.

Viral Transport Medium Tube – Saliva sample collector
Model: see FSN
Lot: see FSN

IVD: Sampling Kits

DE-1-Suzho Yuno
DE-1-Tai Zhou Sun Trine
FR-1-Suzho Yuno
FR-1-Tai Zhou Sun Trine
IT-1-Suzho Yuno
IT-1-Tai Zhou Sun Trine
EN-1-Suzho Yuno
EN-1-Tai Zhou Sun Trine

Vk_20210707_07

15.04.2020 

(Updated 23.07.2021)

Elekta, Inc.

Monaco RTP System
Model: N/A
Lot: N/A
S/N: N/A
SW-Version: Version 5.40 and 5.40.1

MD: Radiation therapy software

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

Vk_20200407_09

28.11.2019 

(Updated 23.07.2021)

Elekta, Inc.

Monaco RTP System
Model: N/A
Lot: N/A
S/N: N/A
SW-Version: Version 5.40 and higher

MD: Radiation therapy software

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

Vk_20191120_17

20.07.2021 

(Updated 22.07.2021)

Teleflex Medical SND BHD

Endotracheal Tube – with cuff – Murphy – Sterile pack
Model: see FSN

Flexiset SUPER SAFETY CLEAR TRACHEALTUBUS
Model: see FSN

Ruschelit Safety Clear Plus Tracheal Tube, oral/nasal, cuffed
Model: see FSN

Flexi-Set Cuffed Endotracheal Tube and Stylet Set and Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
Model: see FSN

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Artificial airway stylet, single-use

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

Vk_20210719_27

20.07.2021 

(Updated 22.07.2021)

Teleflex Malaysia

PERCUQUICK ONE-STEP SET, PDT
Model: see FSN
Lot: see FSN

PERCUQUICK ONE-STEP DILATOR
Model: see FSN
Lot: see FSN

MD: Tracheostomy kit, single-use

MD: Tracheostomy kit, single-use

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

Vk_20210719_12

13.07.2021 

(Updated 22.07.2021)

Gyrus ACMI Inc.

SOLTIVE PREMIUM LASER & SOLTIVE PRO LASER
Model: Premium EGTFL-PLS, Pro EGTFL-SLS

MD: The Soltive Laser is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery.

DE-1
EN-1

Vk_20210708_16

08.06.2021 

(Updated 22.07.2021)

Smith & Nephew Medical Ltd.

JELONET
Model: 7403
Lot: 202018; 202019; 202020; 202021 ; 202022 and 202036

MD: Wound-nonadherent dressing, permeable, non-antimicrobial

DE-1
FR-1
FR-2

Vk_20210602_06

21.07.2021

B. Braun Melsungen AG

Combitrans Monitoring Set with Hämofix reservoir
Model: 5200181, 5200182, 5200183, 5200184, 5201428, 5201432, 5201819, 5204781, 5208388, 5210349, 5213505, 5213516, 5213527, 5218347, 5218655, 5219655, 5319553, 5770063, 5770064, 5770543, 5770544, 5770546

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

DE-1
IT-1

Vk_20210713_20

20.07.2021

GE Healthcare

Centricity Critical Care

MD: Patient health record information system

FR-1
EN-1

Vk_20210719_29

20.07.2021

Respironics California, LLC

V60 Ventilator
Model: V60, V60 Plus
Lot: NA
S/N: See UAL86600059
SW-Version: 3.00 and 3.01

V60 Plus Ventilator
Model: V60, V60 Plus
S/N: See UAL86600059
SW-Version: 3.00 and 3.01

MD: Portable electric ventilator

MD: Portable electric ventilator

DE-1
EN-1

Vk_20210715_02

20.07.2021

Apollo Endosurgery Inc

Orbera Intragastric Balloon System
Model: B-50000

BIB Intragastric Balloon System
Model: B-40800

Orbera365 Intragastric Balloon System
Model: B-50012

MD: Appetite-suppression gastric balloon

MD: Appetite-suppression gastric balloon

MD: Appetite-suppression gastric balloon

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

Vk_20210714_07

05.05.2021 

(Updated 20.07.2021)

N.G.C. Medical srl

Prontopac
Model: PP/CH-PFSZ-EMO1; PP/CH-PFSZ-PMK1
Lot: see FSN

PERICARDIOCENTESIS KIT
Model: LMP004P6
Lot: see FSN

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

MD: Pericardiocentesis catheter

DE-1
DE-2
FR-2
IT-1
EN-Product List

Vk_20210426_23

19.07.2021

Schwarzer Cardiotek GmbH

Evolution core
Model: see FSN
SW-Version: 4.3.0 up to 4.3.9

MD: Cardiac catheterization laboratory computer

DE-1
EN-1

Vk_20210712_37

19.07.2021

Philips Goldway (Shenzhen) Industrial Inc.

HeartStart Intrepid Monitor/Defibrillator
Model: 867172
Lot: NA
S/N: see UAL86199999A
SW-Version: NA

MD: Rechargeable professional automated external defibrillator

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

Vk_20210702_20

19.07.2021

CooperSurgical Inc.

Oxygen Sensors
Model: K54019-2 – Oxygen Sensor

MD: Oxygen electrode

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

Vk_20210701_12

29.03.2021 

(Updated 19.07.2021)

Medtronic Inc.

Activa Clinician Programmer Application
Model: Modell A610
S/N: all
SW-Version: Versionen 2.0.4584, 2.0.4594, 2.0.4605 und 3.0.1057

AIMD: Multiple active implantable device programmer

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

Vk_20210310_25

07.04.2021 

(Updated 18.07.2021)

Radiometer Medical ApS

ABL90 FLEX
Model: 393-090
S/N: ABL90 FLEX analyzers with a E3800 PC unit installed.

ABL90 FLEX PLUS
Model: 393-092
S/N: ABL90 FLEX PLUS analyzers with a E3800 PC unit installed.

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

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

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

Vk_20210331_12

11.12.2020 

(Updated 15.07.2021)

Cardiac Pacemaker Inc

EMBLEM S-ICD Subcutaneous Electrode (Lead)
Model: Model 3501
Lot: N/A
S/N: All
SW-Version: N/A

AIMD: Endocardial defibrillation lead

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_20201203_08

14.07.2021

Thommen Medical AG

VARIOflex abutment set for crown
Model: 1.04.831
Lot: 24986

MD: Dental implant suprastructure kit

EN-1

Vk_20210708_08

13.07.2021

Merit Medical Systems, Inc.

basixALPHA(TM)
Lot: all

MD: Catheter/overtube balloon inflator, single-use

DE-1

Vk_20210709_15

13.07.2021

Medtronic Inc.

Vectris SureScan Lead Kit
Model: 977A260, 977A275, 977A290
Lot: n/a
S/N: 977A20024V, 977A20025V , 977A20028V
SW-Version: n/a

AIMD: Neural-tissue electrical stimulation lead

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

Vk_20210708_10

13.07.2021

Illumina, Inc

VeriSeq NIPT Solution v2
Model: 20030577; VeriSeq NIPT Sample Prep Kit (24 Sample): 20025895, VeriSeq NIPT Sample Prep Kit (48 Sample): 15066801, VeriSeq NIPT Sample Prep Kit (96 Sample): 15066802
Lot: A162301, A162261, A161869, A162106, A162522, A162609

IVD: Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

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

Vk_20210708_02

13.07.2021

GE / OEC Medical Systems Inc.

OEC Elite

OEC 3D

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

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

DE-1
FR-1
IT-1

Vk_20210706_21

13.07.2021

GE Healthcare

SIGNA PET/MR
SW-Version: see FSN

SIGNA Pioneer, SIGNA Premier
SW-Version: see FSN

SIGNA Voyager
SW-Version: see FSN

Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist
SW-Version: see FSN

1.5T Signa HDxt, SIGNA Creator, SIGNA Explorer
SW-Version: see FSN

MD: PET/MRI system

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

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

Vk_20210702_19

12.07.2021

TORNIER SAS

Inspyre Interpositional Shoulder Implant
Model: All sizes; DWE130, DWE132, DWE134, DWE136, DWE138, DWE140, DWE142, DWE144, DWE146, DWE148, DWE150
Lot: ALL
S/N: /
SW-Version: N/A

MD: Stem-fixed humeral head prosthesis

DE-1
FR-1

Vk_20210621_02

12.07.2021

Arcoma AB

Precision
Model: 0072 (T3, T4)
Lot: N/A
S/N: 2001-2224, 2226-2232, 2234-2238, 2240-2245, 2247, 2251-2253, 2255, 2260
SW-Version: N/A

MD: Stationary basic diagnostic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20210616_09

29.06.2021 

(Updated 09.07.2021)

Roche Diagnostics GmbH

cobas u pack
Model: 06334601001

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

DE-1
FR-1
EN-1

Vk_20210623_22

09.07.2021

TORNIER SAS

Aequalis Pyrocarbon Humeral Head
Model: All sizes; DWH039, DWH041, DWH043, DWH046, DWH048, DWH050, DWH051, DWH052, DWH053, DWH054, DWH139, DWH141, DWH143, DWH146, DWH148, DWH150, DWH151, DWH152, DWH153, DWH154
Lot: ALL

MD: Stem-fixed humeral head prosthesis

DE-1
FR-1

Vk_20210621_01

08.07.2021

B. Braun Melsungen AG

Combidyn Druckschlauch PE 120 CM, TRANSPARENT
Model: 5201281
Lot: 21E05E8SKA

MD: Invasive blood pressure monitoring tubing set

DE-1

Vk_20210705_02

08.07.2021

Baxter Healthcare SA

EASYGRIP FLO-41 Precision MIS Delivery System
Model: ADS201865
Lot: 0000345821, 0000350308, 0000357425, 0000366117, 0000368579, 0000379816
S/N: NA
SW-Version: N/A

MD: Haematological concentrate system applicator, endoscopic

EN-1

Vk_20210621_05

07.07.2021

Pall Medical – A Division of Pall International Sàrl

Pall Nanodyne ELD Filter
Model: ELD96LLCE
Lot: 21-674, 21-683

Pall Lipipor TNA-Filter
Model: TNA1E
Lot: 21-678, 21-716, 21-727

MD: Intravenous line filter

MD: Intravenous line filter

DE-1
FR-1
EN-1

Vk_20210705_01

07.07.2021

Angiomed GmbH & Co. Medizintechnik KG

Gastrotop Bile Endoprosthesis Set
Model: see FSN
Lot: refer to Appendix 1 of the FSN

High Flex Basket
Model: see FSN
Lot: refer to Appendix 1 of the FSN

Ecoflex Basket
Model: see FSN
Lot: refer to Appendix 1 of the FSN

MD: Bile duct prosthesis

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

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

DE-1

Vk_20210630_21

05.07.2021 

(Updated 07.07.2021)

Beckman Coulter , Inc.

Kaluza C Software
Model: C10574, C10575, C10576, C10577, C10578, C10579, C10580, C10581, C21166
SW-Version: 1.0*, 1.1.1, 1.1.2

IVD: Laboratory instrument/analyser application software IVD

DE-1
FR-1
EN-1

Vk_20210628_22

06.07.2021

Siemens AG Healthcare

Artis zee/Q/Q.zen systems
Model: see enclosure; see enclosure
S/N: Artis zee / Q / Q.zen Systeme mit SW VD12, ———————————————, Artis zee / Q / Q.zen systems with SW VD12

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20210705_21

06.07.2021

Mentor Medical Systems B.V.

Siltex Round High Profile
Model: 354-4150
Lot: 9522528

MD: Silicone gel-filled breast implant

DE-1

Vk_20210702_23

06.07.2021

GE Medical Systems Information Technologies, Inc.

Patient Data Module
Model: See FSN

MD: Patient monitoring system module, multifunction

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

Vk_20210629_10

06.07.2021

NVT GmbH

ALLEGRA Delivery System TF
Model: DSL-AO18G1RE1150
Lot: see FSN

MD: Transcatheter heart valve bioprosthesis implantation catheter

DE-1
EN-1

Vk_20210629_01

05.07.2021

Meyra GmbH + Co

Scooter CL409/CL510
Model: 1.254, 1.264
S/N: 8928128000036 / 8931468000154

MD: Scooters, Powered

DE-1
FR-1
IT-1

Vk_20210625_15

05.07.2021

SONY Corporation

SONY LMD-1951MD MONITORS
Model: LMD-X2700MD, LMD-X2705MD, LMD-X2705N; LMD-X2700MD, LMD-X2705MD, LMD-X2705N
S/N: LMD-X2700MD: 3000002-3000091, LMD-X2705MD: 3000096-3001806, 3100001-3100804, LMD-X2705N: 3000003-3000108

MD: Image display monitor, colour

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

Vk_20210623_06

30.06.2021 

(Updated 02.07.2021)

bioMérieux SA

ETEST IMIPENEM RELEBACTAM
Model: 420925, 420927
Lot: See FSN
S/N: N/A
SW-Version: N/A

IVD: Antibacterial minimum inhibitory concentration (MIC) IVD

FR-1
EN-1

Vk_20210628_27

02.07.2021 

(Updated 02.07.2021)

Sengewald Klinikprodukte GmbH

Custom Procedure Trays containing syringes and needles from BD

MD: Infusion And Irrigation Syringes, 2-piece Luer Cone, Single-use

DE-1
EN-1

Vk_20210617_19

14.06.2021 

(Updated 02.07.2021)

Medtronic Inc.

Deep Brain Stimulation (DBS) Lead Kits
Model: 3387S, 3389S, 3391S
Lot: see FSN
S/N: N/A
SW-Version: N/A

Stimloc Spares Kit
Model: 3550S-01
Lot: see FSN

Stimloc Burr Hole Cover
Model: 924256
Lot: see FSN

StimLoc Support Clips
Model: DB5000
Lot: see FSN

AIMD: Deep brain electrical stimulation system

AIMD: Craniofacial fixation plate, non-bioabsorbable

AIMD: Deep brain electrical stimulation system

AIMD: Deep brain electrical stimulation system

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

Vk_20210602_15

01.07.2021

W. L. Gore & Associates

GORE PROPATEN Vascular Graft
Model: GORE® PROPATEN® Vascular Graft; HPT050010/HPT060015
S/N: see Attachment 1
SW-Version: not applicable

MD: Synthetic vascular graft

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

Vk_20210628_07

01.06.2021 

(Updated 01.07.2021)

Roche Diagnostics GmbH

cobas 6500 urine analyzer series
Model: see FSN
SW-Version: see FSN

cobas u 701 microscopy analyzer
Model: see FSN
SW-Version: see FSN

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

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

Vk_20210527_28