Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2023 – 31.12.2023

(Updated )

Medtronic Navigation Inc.

StealthStation S8 Software App
Model: 9735762
S/N: All
SW-Version: 2.0, 2.0.1

MD: Multi-purpose stereotactic surgery system

DE-1
DE-2.1
DE-2.2
FR-1
FR-2.1
FR-2.2
IT-1
IT-2.1
EN-1
EN-2.1
EN-2.2

Vk_20230928_19

(Updated )

William A. Cook Australia Pty. Ltd.

MINC+ Benchtop Incubator
Model: K-MINC-2000; G44429

MD: Assisted reproduction heater/incubator

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

Vk_20231206_02

(Updated )

Ecolab Deutschland GmbH

Incidin OxyWipe S
Model: 3082240; 3116020; 3092040; 3116100;
Lot: all Lots
S/N: all S/N

Incidin OxyFoam S
Model: 3115790; 3115900; 3082060; 3087450
Lot: all Lots
S/N: all S/N

MD: Medical device cleaning/disinfection wipe

MD: Medical device disinfection agent

DE-1
FR-2
IT-1

Vk_20231127_06

(Updated )

icotec ag

icotec Torque Wrench
Model: REF 42-702
Lot: n.a.
S/N: all Serial Numbers

MD: Neurosurgery And Spinal Surgery Instrument Kits, Reusable

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

Vk_20231219_01

(Updated )

Covidien llc

Sofsilk Wax/silicone Coated Braided Silk
Model: affected devices in Switzerland: S-303 SOFSILK* 4-0 BLK 12x75CM PCT X36; SS-681 SOFSILK 6-0 BLK 45CM C12 X36
Lot: affected devices in Switzerland: S303: D2D2120RY; SS-681: D2G0795FRY

MD: Silk suture

DE-1
DE-2
EN-2

Vk_20231221_06

(Updated )

Philips Medical Systems Nederland B.V.

BrightView
Model: 882480

BrightView X
Model: 882478

BrightView XCT
Model: 882482

MD: Stationary gamma camera system

MD: Stationary gamma camera system

MD: PET/CT system

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

Vk_20231204_25

(Updated )

Philips Medical Systems Nederland B.V.

Spectral CT 7500
Model: 728333, 728340
SW-Version: 5.0.0.X

MD: Full-body CT system

DE-1
FR-1
EN-1

Vk_20231204_27

(Updated )

Philips Respironics, Inc

Trilogy Evo
Model: See FSN
Lot: Not Applicable
SW-Version: Not Applicable

Trilogy Evo O2
Model: See FSN
Lot: Not Applicable

MD: Portable electric ventilator

MD: Portable electric ventilator

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

Vk_20231130_13

(Updated )

Drägerwerk AG & Co. KGaA

Atlan
Model: 8621300, 8621400, 8621500, 8621600
S/N: all

MD: Anesthesia Units

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

Vk_20231204_01

(Updated )

Remote Diagnostic Technologies Ltd.

Tempus Pro Patient Monitor
Model: 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R

MD: Multiple vital physiological parameter monitoring system, clinical

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

Vk_20230828_17

(Updated )

Löwenstein Medical Technology GmbH + Co. KG

LM150TD
Model: LUISA, TIVAN LS, Life One
S/N: all

MD: Portable electric ventilator

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

Vk_20231220_28

(Updated )

Cristalens Industrie

Clare

Quatuorevo

Cristal

Artis

Lucis

MD: Posterior-chamber intraocular lens, pseudophakic

MD: Posterior-chamber intraocular lens, pseudophakic

MD: Posterior-chamber intraocular lens, pseudophakic

MD: Lens

MD: Lens

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

Vk_20231222_36

(Updated )

Cordis Cashel

OPTEASE Retrieval Catheter
Model: 466C210F
Lot: All unexpired lots

OptEase Retrievable Vena Cava Filter
Model: 466F210AF, 466F210AJ, 466F210BJ
Lot: All unexpired lots

MD: Intravascular extraction catheter-snare

MD: Vena cava filter, temporary/permanent

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

Vk_20231222_25

Philips Medical Systems Nederland B.V.

Philips Azurion 7 M20 FlexArm system with Maquet M
Model: 722224
S/N: 2057
SW-Version: Azurion – 2.x, Maquet Magnus Table 05.02.12

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

DE-1

Vk_20231214_06

Ecolab Deutschland GmbH

Incidin Rapid
Model: 3025510, 3028700, 3040230, 3041970, 3096580, 3097310, 3097420, 3097480, 3601440
Lot: All

MD: Medical device disinfection agent

DE-1
FR-1
IT-1

Vk_20231218_36

MAQUET Cardiopulmonary GmbH

Tubing Sets with Hemoconcentrator
Model: 701005142
Lot: 3000242892; 3000273199
S/N: N/A
SW-Version: N/A

MD: Cardiopulmonary bypass system blood tubing set

DE-1
EN-1

Vk_20231222_24

B. Braun Melsungen AG

Pencan
Model: 4502043-13; 4502116-13
Lot: 23E24H8B05; 23E30H8B04

Introducer Needle
Model: 4505000-13
Lot: 22G28G8841

MD: Needle guide, single-use

MD: Introducer, syringe needle

DE-1
FR-1
IT-1

Vk_20231222_05

Fresenius Medical Care AG & Co. KGaA

multiFiltratePRO
Model: M205001
SW-Version: SW version 6.02 now available

MD: Haemodialysis system, institutional/home-use

DE-1
FR-1
IT-1

Vk_20231228_14

Siemens Healthcare Diagnostics Inc.

Atellica CH Immunoglobulin M_2 (IgM_2)
Model: 11097620
Lot: 221764 and above
S/N: N/A

IVD: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

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

Vk_20231227_18

Welch Allyn, Inc.

Q-Stress
Model: Q-Stress version 6 or higher
Lot: See FSN

Xscribe
Model: XScribe version 6 or higher, Xscribe CP
Lot: See FSN

MD: Cardiopulmonary stress exercise monitoring system computer

MD: Cardiopulmonary stress exercise monitoring system computer

DE-1
FR-1
IT-1

Vk_20231213_12

B-K Medical AS

Ultrasound system type 2300
Model: See FSN
Lot: See FSN
SW-Version: 5.16.8 / 5.16.12 / 5.16.14

MD: General-purpose ultrasound imaging system

DE-1
FR-1
IT-1

Vk_20231219_29

OrthoSpace Ltd.

InSpace Medium
Model: 0128
Lot: see FSN

MD: Tendon spacer

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

Vk_20231227_16

(Updated )

Medtronic Navigation Inc.

Synergy Cranial, StealthStation Cranial
Model: 9735585, 9735586, 9735587
S/N: All
SW-Version: 3.1.4

MD: Neurological stereotactic surgery system

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

Vk_20230413_08

(Updated )

LifeGlobal Group, LLC

global Medium
Model: LGGG-020, LGGG-050, LGGG-100
Lot: LGGG-020: 231020-018741 , LGGG-050: 231020-018742 , LGGG-100: 231020-018743

MD: IVF medium

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

Vk_20231218_11

Shimadzu Corporation

SPD-40 CL
Model: SPD-40 CL; 228-65312-55

IVD: High performance liquid chromatography analyser IVD

EN-1

Vk_20231222_32

Philips Medical Systems Nederland B.V.

Philips BrightView, X, XCT
Model: 882480, 882478, 882482; N/A
S/N: 6000059, 6000097, 6000192, 6000258, 6000259, 6000278, 6000376, 6000379

MD: Full-body CT system

DE-1
FR-1
EN-1

Vk_20231219_21

(Updated )

Mikrogen GmbH

recomLine HIV Rev001 Build001.stc, recomLine HIV Rev001 Build002.stc
SW-Version: recomScan 3.4

IVD: In Vitro Diagnostic Medical Devices

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

Vk_20231123_02

Randox Laboratories Ltd

COPPER (Cu)
Model: CU2340
Lot: see FSN

IVD: Copper IVD, kit, spectrophotometry

FR-1
IT-1
EN-1

Vk_20231215_01

(Updated )

Stryker Orthopaedics

Scorpio Total Knee System
Model: see FSN
Lot: see FSN

Duracon
Model: see FSN
Lot: see FSN

PCA
Model: see FSN
Lot: see FSN

TRIDENT Poly Inserts
Model: see FSN
Lot: see FSN

MD: Unicondylar knee prosthesis

MD: Knee prosthesis, internal, total

MD: Tibial insert

MD: Acetabulum prosthesis

DE-1
FR-1
EN-1

Vk_20231213_10

MAQUET Cardiopulmonary GmbH

HLS Set Advanced 5.0
Model: 701069073, 701069076
Lot: See Annex I of FSN

MD: Cardiopulmonary bypass system blood tubing set

DE-1
FR-1
EN-1

Vk_20231222_13

(Updated )

Randox Laboratories Ltd

Calibration Serum Level 3
Model: CAL2351
Lot: see FSN

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

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

Vk_20231206_19

(Updated )

Medex

Secufill
Model: 218684 (SECU002); 240134 (SECU005)
Lot: LX221001, LX2212-01, LX2213-01, LX2214-01, LX222901, LX223601, LX223701, LX223801, LX223901, LX224001, LX224101, LX224201, LX233601, LX233701
SW-Version: N/A

MD: Radiographic procedure tubing

DE-1
FR-1
FR-2

Vk_20231219_02

(Updated )

Olympus Medical Systems Corp.

Single Use Distal Cover
Model: MAJ-2315, N6192000
Lot: All

MD: Endoscope patient protection cap, single-use

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

Vk_20231215_27

(Updated )

DH Healthcare GmbH

DeepUnity Diagnost
Model: all versions

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20231213_24

DH Healthcare GmbH

DeepUnity Diagnost

MD: Picture Archiving And Communication Systems

DE-1
EN-1

Vk_20231213_23

(Updated )

Abbott Ireland Diagnostic Division

Alinity i HBsAg Reagent Kit
Model: 08P0852
Lot: 51503FN00

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

DE-1
EN-1

Vk_20231213_22

(Updated )

Ortho Clinical Diagnostics

ORTHO VISION Max Analyser
Model: 6904578

ORTHO VISION Analyser
Model: 6904579

IVD: Immunohaematology/blood bank analyser IVD

IVD: Blood group/antibody screening analyser IVD

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

Vk_20231117_11

(Updated )

Philips Medizinsysteme Böblingen GmbH

Patient Information Center iX
Model: 866389, 866390

Care Event
Model: 866435, 866436

PIC iX Hardware
Model: 866424

MD: Centralized patient monitor

MD: Hospital-administration information system

MD: Centralized patient monitor

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

Vk_20231206_01

Mölnlycke Health Care AB

Mölnlycke Procedure trays
Model: 97016566-17
Lot: 23428217, 23428292, 23386936, 23428291

MD: GMDN code not available

DE-1
EN-1

Vk_20231207_06

(Updated )

Siemens Healthcare GmbH

ARTIS icono biplane

ARTIS icono floor

ARTIS pheno

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

Vk_20221219_01

(Updated )

Medtronic Navigation Inc.

Sterile Percutaneous Reference Pin
Model: 9733235, 9733236
Lot: Model 9733235: 2023010549, 2023041134, 2023051138. Model 9733236: 2022030438, 2023041141, 2023051457

MD: Orthopaedic stereotactic surgery system

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

Vk_20231206_15

Bio-Rad Medical Diagnostics GmbH

Anti-Dia (DI1)
Model: 808270
Lot: 3125010-00, exp. date: 06-Jun-2024, 3149050-00, exp. date: 03-Jan-2025, 3215020-00, exp. date: 26-Mar-2025, 3248070-00, exp. date: 15-Nov-2025, 3332050-00, exp. date: 24-Jul-2026

IVD: Anti-Di^a red blood cell grouping IVD, antibody

EN-1

Vk_20231213_02

Philips Medical Systems Nederland B.V.

Spectral CT 7500
Model: 728334, 728333, 728340
S/N: 10042, 10065, 10075, 10077, 10120, 10143, 10156
SW-Version: V5.1.0.X (728334) and V5.X (728333 728340)

MD: Full-body CT system

DE-1
FR-1
EN-1

Vk_20231218_24

(Updated )

Samsung Electronics Co., Ltd

GM85
Model: GM85
S/N: 5149M3U100001F

MD: Mobile basic diagnostic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20231208_18

Tulip Medical Products

Tulip Cannulas & Accessories
Model: BENXXYYZZCF, CARXXYYZZCF, CBBXXYYZZCF, FLPXXYYZZCF, INFXXYYZZCF, MERXXYYZZCF, MILXXYYZZCF, PYRXXYYZZCF, SORXXYYZZCF, SPOXXYYZZCF, STDXXYYZZCF, STDXXYYZZCF, TSHXXYYZZCF, INJXXYYZZCF

MD: Liposuction system cannula, reusable

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

Vk_20231101_12

ALTER ECO SANTE

DEBARLI90

DEBARCOUL90

DEBARCOUL90.02

DEHAUBAR90

DECLIBAR90

ZSANVELNC

MD: Aids, Furniture And Home Aids For Persons With Disabilities

MD: Aids, Furniture And Home Aids For Persons With Disabilities

MD: Aids, Furniture And Home Aids For Persons With Disabilities

MD: Aids, Furniture And Home Aids For Persons With Disabilities

MD: Aids, Furniture And Home Aids For Persons With Disabilities

MD: Aids, Furniture And Home Aids For Persons With Disabilities

FR-1

Vk_20231208_03

Olympus Medical Systems Corp.

EZDilate Fixed Wire Balloon
Model: EGBD-400P-1080, EGBD-400P-1380, EGBD-400P-1580, EGBD-400P-1880, EGBD-400P-2080
Lot: see FSN

EZDilate Wire Guided
Model: EGBD-410X-0855, EGBD-410X-1055, EGBD-410X-1355, EGBD-410X-1555, EGBD-410X-1855, EGBD-410X-2055
Lot: see FSN

MD: Gastrointestinal/biliary dilation balloon catheter

MD: Gastrointestinal/biliary dilation balloon catheter

DE-1

Vk_20231129_07

(Updated )

Bio-Rad

Monolisa HCV Ag-Ab ULTRA V2
Model: 72561 and 72562
Lot: 2J0063, 2L0064, 3A0065, 3B0066, 3B1066, 3C0067, 3H0068, 3K0069, 2J0579, 2L0580, 3A0581, 3B0582, 3D0583, 3F0584, 3H0585, 3K0586

IVD: Hepatitis C virus antibody/antigen IVD, kit, enzyme immunoassay (EIA)

DE-1
EN-1

Vk_20231201_26

(Updated )

MAQUET Cardiopulmonary GmbH

CARDIOHELP-i
Model: 701048012, 701072780 (US Variant); see model number
S/N: All devices delivered between production start and 2023-03-09

MD: Cardiopulmonary bypass system, roller type

DE-1
FR-1
EN-1

Vk_20231030_05

Medivators Inc

Hookup (accessory)
Model: See FSN
Lot: See FSN

MD: Luer/non-ISO80369-standardized linear connector, reusable

EN-1

Vk_20231121_14

Renishaw Mayfield SARL

Neuromate
SW-Version: V6.2.2 and above

MD: neuromate stereotactic surgery system

EN-1

Vk_20231208_19

(Updated )

GME German Medical Engineering GmbH

LinScan
Model: 1050

TwinScan
Model: 1060

MD: Photoepilation Equipment

MD: Photoepilation Equipment

DE-1
FR-1
EN-1

Vk_20231129_15

(Updated )

The Insides Company Limited

THE INSIDES Driver
Model: see FSN
Lot: see FSN
S/N: see FSN

MD: Diverting enterostomy re-feeding pump

DE-2
FR-2
EN-2

Vk_20231016_13

Alpha Bio Tec

MultiNeO NH Implant
Model: 9300, 9301, 9303, 9306, 9308, 9320, 9321, 9323, 9326, 9328, 9330, 9331, 9333, 9336, 9338, 9340, 9341, 9343, 9346, 9348, 9350, 9351, 9353, 9358
Lot: see FSN
SW-Version: NA

MD: Screw endosteal dental implant, two-piece

EN-1

Vk_20231204_05

(Updated )

GeneProof a.s.

GeneProof Enterovirus PCR Kit
Model: EV/ISEX/025; EV/ISEX/100
Lot: see FSN

IVD: Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)

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

Vk_20231127_03

Gyrus ACMI, Inc.

SOLTIVE Single-use Laser Fibers

MD: General/multiple surgical laser system beam guide, single-use

DE-1
FR-1
EN-1

Vk_20231207_19

Maquet Critical Care AB

Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
Lot: 07325710001349

MD: Anaesthesia workstation, general-purpose

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

Vk_20231211_29

Olympus Medical Systems Corp.

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
Model: LTF-S190-5, LTF-S190-10; N3828050, N3828060, N3828150, N3828160
S/N: All

MD: Rigid video laparoscope

FR-1
IT-1

Vk_20231201_13

(Updated )

Wassenburg Medical B.V

WASSENBURG WD4200 washer-disinfector
S/N: all

MD: Endoscope washer/disinfector

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

Vk_20230726_10

Stihler Electronic GmbH

ASTOPAD
Model: COV, SOF
Lot: see FSN

MD: Patient Warming System

DE-1
FR-1
IT-1

Vk_20231208_12

bioMérieux

VIDAS DENGUE NS1 Ag
Model: 423077
Lot: 1010033400, 1010098270, 1010150640, 1010208490
S/N: N/A
SW-Version: N/A

IVD: Dengue virus antigen IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20231207_13

Megadyne Medical Products, Inc

MEGADYNE MEGA SOFT Universal Patient Return Electrode
Model: 0845
Lot: see FSN

MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode
Model: 0846
Lot: see FSN

MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode
Model: 0847
Lot: see FSN

MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode
Model: 0848
Lot: see FSN

MD: Electrosurgical return electrode, reusable

MD: Electrosurgical return electrode, reusable

MD: Electrosurgical return electrode, reusable

MD: Electrosurgical return electrode, reusable

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

Vk_20231211_34

(Updated )

Philips Medical Systems Nederland B.V.

MultiDiagnost Eleva

Allura Xper

Allura Centron

Philips Azurion system

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

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

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

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

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

Vk_20230818_24

(Updated )

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

Vk_20230720_11

Olympus Medical Systems Corp.

Olympus Flexible Endoscopes
Model: See FSN

MD: Flexible video bronchoscope, colonoscope, cystonephroscope, gastroduodenoscope, duodenoscope, enteroscope

DE-1
FR-1
IT-1

Vk_20231127_19

Olympus Medical Systems Corp.

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

MD: Flexible video duodenoscope, reusable

DE-1
FR-1
IT-1

Vk_20231121_19

Karl Storz SE und Co. KG

BEYER Antrum Punch
Model: 615000
Lot: all

Antrum Punch
Model: 615010
Lot: all

Sphenoid Punch
Model: 615025; 648500; 648523
Lot: all

Galea Spring Hook
Model: 662797
Lot: all

Uvula Retractor
Model: 723014
Lot: all

Optical Biopsy and Grasping Forceps
Model: 723400
Lot: all

Grasping Forceps, flexible
Model: 11003MB
Lot: all

Optical Scissor
Model: 11540OS
Lot: all

Working Insert, with steering lever
Model: 26161UH
Lot: all

MD: Bone punch, reusable

MD: Bone punch, reusable

MD: Bone punch, reusable

MD: Hand-held surgical retractor, reusable

MD: Soft-tissue surgical hook, reusable

MD: Flexible endoscopic tissue manipulation forceps, reusable

MD: Surgical soft-tissue manipulation forceps, scissors-like, reusable

MD: Gynaecological scissors, reusable

MD: Rigid endoscope working guide

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

Vk_20231204_02

Nova Biomedical

Stat Profile Prime Plus Analyzer
Model: 63368, 63369, 5740, 59508
SW-Version: W1.17.1129.0, W3.2.1129.0

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

DE-1
EN-1

Vk_20231130_11

(Updated )

Becton Dickinson Diagnostic Systems

BD BACTEC MicroMGIT Calibration Vial
Model: 441049
Lot: 2067938, 2209320

IVD: Blood culture analyser IVD

DE-1
DE-2
EN-2

Vk_20231108_30

Integra LifeSciences Corp

CODMAN VPV SYSTEM
Model: 823192R
S/N: V11598

MD: Cerebrospinal fluid shunt valve programmer

FR-1
EN-1

Vk_20231204_12

ArcRoyal uc, an Owens and Minor Company

CHA229 HERZ – SET / ECC
Model: CHA229
Lot: 790728, 785541, 786805, 787717, 788551

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

DE-1
EN-1

Vk_20231205_01

Cardiac Pacemaker Inc

ZOOM Programmer Model 3120
Model: 3120
S/N: all serial numbers
SW-Version: Model 2892

AIMD: Cardiac pulse generator programmer

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

Vk_20231201_16

Cardiac Pacemaker Inc

INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps)
Model: See FSN
S/N: See FSN

AIMD: Pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) GMDN 47265, 47263

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

Vk_20231201_17

Siemens Healthcare GmbH

Sensis
Model: see enclosure; see enclosure
S/N: Sensis / Sensis Vibe systems with software version VD15B

MD: Cardiac catheterization laboratory computer

DE-1
FR-1

Vk_20231201_24

(Updated )

Medtronic Inc.

SynchroMed II
Model: 8637-20, 8637-40
S/N: All

MD: General-purpose implantable infusion pump, programmable

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

Vk_20231122_31

CapnoPharm GmbH

Capnopen
Model: CP-001k
Lot: 94977

MD: Nebulizers

DE-1
FR-1

Vk_20231123_04

Hubert De Backer nv

Dosing Pipette
Model: T2023+T2024; WEPA Product Reference: 032401
Lot: 22-2084/00, 22-2493/00, 22-2570/00
S/N: Not Applicable
SW-Version: Not Applicable

MD: Reusable Syringes – Other

EN-1

Vk_20231116_23

Caesarea Medical Electronics Limited

BodyGuard Infusion Pumps Systems (LVP)
Model: See FSN

MD: Bedside infusion pump, multichannel

DE-1

Vk_20231124_10

(Updated )

Illumina, Inc

NextSeq 550Dx
Model: 20005715

MiSeqDx Instrument
Model: DX-410-1001 / 15036706 / 20014053

IVD: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

IVD: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

DE-1
DE-2 (MiSeq)
DE-2 (NextSeq)
FR-1
FR-2 (MiSeq)
FR-2 (NextSeq)
IT-1
IT-2 (MiSeq)
IT-2 (NextSeq)
EN-1
EN-2 (MiSeq)
EN-2 (NextSeq)

Vk_20220509_16

(Updated )

Beckman Coulter Biomedical GmbH

DxA 5000
Model: B50516
S/N: All

IVD: Specimen processing instrument IVD

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

Vk_20230614_21

(Updated )

HUMAN Gesellschaft für Biochemica und Diagnostica mbH

Autocal
Model: 13160
Lot: 0018 to 0018P, 0019 to 0019C

HumaTrol N, HumaTrol P, SERODOS, SERODOS PLUS, ACID PHOSPHATASE, ALKALINE PHOSPHATASE opt. liquicolor, LDH SCE mod. liquiUV, PHOSPHORUS liquirapid
Model: see FSN
Lot: see FSN

IVD: Calibrators Multicomponent (CC)

IVD: CLINICAL CHEMISTRY

DE-1
FR-1
EN-1

Vk_20231114_04

VOSTRA GmbH

RHINOTAMP latexfrei
Model: see FSN
Lot: see FSN

RHINOTAMP
Model: see FSN
Lot: see FSN

MD: Nasal Balloons

MD: Nasal Balloons

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

Vk_20231124_13

Actim Oy

Actim PROM, Actim PROM 1ngeni
Model: 30830ETAL, 30831ETAL, 30832ETAL, 30832RETAL
Lot: Not lot specific
SW-Version: NA

IVD: Rapid Tests & Point Of Care – Immunochemistry – Other

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

Vk_20231116_20

Actim Oy

Actim Partus
Model: 31930ETAL, 31931ETAL
Lot: Not lot specific
SW-Version: NA

IVD: Bedside rapid test to estimate the risk of preterm delivery

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

Vk_20231116_21

Covidien llc

Valleylab FT10
Model: VLFT10GEN
S/N: all
SW-Version: 4.0.1, 4.0.2 and 4.0.3

MD: Electrosurgical system generator

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

Vk_20231121_25

bioMérieux

VIDAS CK-MB
Model: 30421
Lot: 1009900940

IVD: Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20231123_09

Bard Peripheral Vascular Inc.

Bard Mission Disposable Core Biopsy Kit
Model: see FSN
Lot: see attachment

MD: Side-notch biopsy gun handpiece/needle

DE-1
FR-1
IT-1

Vk_20231117_10

(Updated )

Olympus Medical Systems Corp.

HIGH FLOW INSUFFLATION UNIT
Model: UHI-4 / N3829650, N3829660, N3829670
S/N: All

MD: Laparoscopic insufflator

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

Vk_20230928_18

B. Braun Melsungen AG

Combitrans Monitoring Set
Model: see FSN
Lot: all

Combidyn Monitoring Set
Model: see FSN
Lot: all

MD: Invasive blood pressure transducer set

MD: Invasive blood pressure transducer set

DE-1
FR-1
IT-1

Vk_20231127_16

Leica Biosystems Nussloch GmbH

Leica Biosystems Tissue processor
Model: 14048858005, 14048858007
S/N: HistoCore Pegasus: G0061-G0701, HistoCore Pegasus Plus: P0061-P0211

IVD: Tissue processor IVD, automated/semi-automated

DE-1
FR-1
EN-1

Vk_20231115_22

Abbott Molecular Inc.

Alinity m BKV AMP Kit
Model: 09N85-090
Lot: 391674

IVD: Bk Virus – Na Reagents

DE-1
EN-1

Vk_20231122_23

(Updated )

MAQUET Cardiopulmonary GmbH

Heater-Cooler Unit HCU 40 High Voltage
Model: 701044054
S/N: all

MD: Cardiopulmonary bypass system heat exchanger, reusable

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

Vk_20230306_19

DiaSys Diagnostic Systems GmbH

GLDH FS DGKC
Model: 1 2411
Lot: see FSN

IVD: Glutamatdehydrogenase

DE-1
EN-1

Vk_20231123_11

Smiths Medical ASD, Inc.

Medfusion Syringe Infusion pump
Model: See FSN
Lot: See FSN
SW-Version: See FSN

MD: Bedside syringe pump

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

Vk_20231127_13

(Updated )

Bort GmbH

Bort X-Walker
Model: 101300, 101320, 101350
Lot: 20230313-001, 20230313-002, 20230313-003

MD: Ankle/foot orthosis

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

Vk_20231027_10

(Updated )

Intuitive Surgical, Inc

Da Vinci X / Xi Surgical System
Model: see FSN
S/N: see FSN
SW-Version: Not applicable

MD: Robotic surgical arm system

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

Vk_20230309_12

Ambu A/S

Ambu aView 2 Advance
Model: 405011000
S/N: see FSN

MD: Endoscopic video image display unit

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

Vk_20231106_32

Olympus Winter & Ibe GmbH

Video Telescope ENDOEYE HD II
Model: WA50040A (0°); WA50042A (30°)

MD: Flexible video laparoscope

DE-1
FR-1
IT-1

Vk_20231115_18

Medical Precision B.V.

Comfort Marker 2.0 Safety Needle
Model: 2022
Lot: 20220525001

MD: Tattoo needle

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

Vk_20231116_14

Merit Medical Systems, Inc.

Merit Maestro , Merit Pursue, Fountain Infusion
Model: See attached FSN enclosure
Lot: See attached FSN enclosure

MD: Peripheral vascular intervention infusion catheter

DE-1

Vk_20231116_11

ResMed PTY LTD

AirFIt F20
Lot: all, see FSN

AirTouch F20
Lot: all, see FSN

MD: CPAP/BPAP face mask, reusable

MD: CPAP/BPAP nasal mask, reusable

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_20231115_17

(Updated )

Cepheid

Xpert Xpress Strep A
Model: XPRSTREPA-10; XPRSTREPA-CE-10
Lot: see FSN

IVD: Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
FR-1
IT-1

Vk_20231115_16

Philips Electronics Nederland B.V.

Philips Panorama 1.0T HFO
Model: 781250, 781350

MD: Full-body MRI system, superconducting magnet

DE-1
FR-1
EN-1

Vk_20231120_33

Ardo medical AG

MASTER
Model: Switzerland: 30.00.33 / Master, 230V, Swiss plug; worldwide: 30.00.31 / Master, 230V, Schuko; 30.00.36 / Master, 230V, with foot switch, Schuko; 30.00.39 / Master, 230V, Schuko, RAL9002; 30.00.40 / Master, 230V, with foot switch, Schuko, RAL9002
S/N: Switzerland: 2315233; worldwide: Master SN range: 2315180 to 2315317

MD: Electrosurgery Instruments – Other

EN-1

Vk_20231108_33

Siemens Healthcare Diagnostics Inc.

RAPIDPoint 500 Systems Measurement Cartridge
Model: see FSN
Lot: N/A
S/N: all

IVD: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

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

Vk_20231116_03

B. Braun Melsungen AG

COROFLEX ISAR NEO
Model: 1) 2.5×19 mm, 2) 2.75×24 mm; 1) 5028933, 2) 5028941
Lot: 1) 23F03809, 2) 23F03809

MD: Drug-coated-metal coronary artery stent

DE-1

Vk_20231113_30

Abbott Laboratories

ARCHITECT c4000
Model: 03R65

Alinity i Processing Module
Model: 03R67

Alinity c Processing Module
Model: 02P24-01; 02P24-40

IVD: Multiple clinical chemistry analyser IVD, laboratory

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Multiple clinical chemistry analyser IVD, laboratory

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

Vk_20231025_15

Drägerwerk AG & Co. KGaA

Gas Management System
Model: DWAQ 4-11, DWAQ 6-10, AWAQ 11-13, DWAQ 11-10, AWAQ 6-13, AWAQT 22-13, DWAQT 18-10, DWAQ 45-10, DWAQ 8-10

MD: Medical Gas/Vacuum Systems

DE-1
FR-1

Vk_20231107_19

(Updated )

Medtronic Inc.

LINQ II Insertable Cardiac Monitor
Model: LNQ22
S/N: RLB288426G, RLB297018G, RLB348117G, RLB338402G, RLB325756G, RLB353306G, RLB370027G, RLB361890G, RLB373851G, RLB373437G, RLB336198G, RLB332569G, RLB327888G, RLB326056G, RLB364656G, RLB358018G, RLB353085G

AIMD: Implantable cardiac monitor

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

Vk_20231102_21

(Updated )

Medtronic MiniMed

Guardian 4 Sensor
Model: MMT-7040C, MMT-7040D, MMT-7040QC
Lot: see FSN

MD: Percutaneous interstitial-fluid glucose monitoring system needle electrode

DE-1-HCP
DE-1-Patient
DE-2-HCP
DE-2-Patient
FR-1-HCP
FR-1-Patient
FR-2-HCP
FR-2-Patient
IT-1-HCP
IT-1-Patient
IT-2-HCP
IT-2-Patient
EN-1-HCP
EN-1-Patient
EN-2-HCP
EN-2-Patient

Vk_20231113_16

(Updated )

BioFire Diagnostics, LLC

BIOFIRE FILMARRAY TORCH
Model: HTFA-ASY-0104
S/N: all

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory

DE-1
FR-1
EN-1

Vk_20231031_12

MAQUET Cardiopulmonary GmbH

CARDIOHELP-i
Model: 701048012; 701072780
S/N: All Cardiohelps until 2021-03

MD: Cardiopulmonary bypass system, roller type

DE-1
FR-1
EN-1

Vk_20231113_35

Medtronic Xomed Inc

NIM TriVantage EMG Endotracheal Tube
Model: 8229706, 8229707, 8229708, 8229736, 8229737, and 8229738
Lot: See FSN

MD: Basic endotracheal tube, single-use

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

Vk_20231107_10

CamDiab Ltd

mylife CamAPS
SW-Version: 1.4(174) and earlier

MD: General Medicine Therapeutic Treatment Instruments – Software Accessories

DE-1.1
DE-1.2
FR-1.1
FR-1.2
IT-1.1
IT-1.2
EN-1.1
EN-1.2

Vk_20231106_08

B. Braun Melsungen AG

SeQuent Please NEO
Model: 3.5×25 mm, 3.5×30 mm; 5023236, 5023246
Lot: 22H13809, 22H10809

MD: Coronary angioplasty balloon catheter, drug-coated

DE-1
FR-1

Vk_20231113_34

Philips Medical Systems Nederland B.V.

Philips Allura Xper
S/N: see FSN

Azurion
S/N: see FSN

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

MD: Stationary angiographic x-ray system, digital

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

Vk_20231102_07

GE Hualun Medical Systems Co Ltd

Definium Tempo
Model: all

Definium Tempo Pro
Model: all

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_20231113_04

(Updated )

Abbott Molecular Inc.

Alinity m HCV AMP Kit
Model: 08N50-090 (08N50-095 in USA and Hong Kong only)
Lot: 383203, 385720, 381581, and 382447

IVD: Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
EN-1

Vk_20231101_28

Medstrom Ltd

Medstrom Solo bed
Model: Solo
Lot: Not applicable
S/N: Not applicable

MD: Basic electric hospital bed

DE-1
FR-1

Vk_20231024_31

(Updated )

BioFire Diagnostics, LLC

BioFire BCID2 Panel
Model: RFIT-ASY-0147
Lot: All unexpired lots, if used with the specified MMQCI control panel

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

DE-1
FR-1
EN-1

Vk_20231030_02

(Updated )

Becton, Dickinson and Company, BD Biosciences

BD CD11b APC
Model: 333143
Lot: 3114710

IVD: Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

DE-1
EN-1

Vk_20231025_02

MAQUET Cardiopulmonary GmbH

Blood Monitoring Unit BMU 40
Model: 70104.0852

MD: Extracorporeal blood gas/pH monitor

EN-1

Vk_20200929_01

(Updated )

Medtronic Inc.

Cobalt
Lot: N/A
S/N: All

Claria MRI / Amplia MRI / Compia MRI / Viva / Brava CRT-Ds
S/N: All

Cobalt XT
S/N: All

Crome
S/N: All

Visia AF / Visia AF MRI / Evera / Evera MRI ICDs
S/N: All

Primo MRI ICD
S/N: All

Mirro MRI ICD
S/N: All

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Dual-chamber implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Single-chamber / Dual-chamber implantable defibrillator

AIMD: Single-chamber / Dual-chamber implantable defibrillator

AIMD: Single-chamber / Dual-chamber implantable defibrillator

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

Vk_20230510_21

HeartWare Inc.

HeartWare Ventricular Assist System (HVAD)
Model: 1104, MCS1705PU

AIMD: Implantable ventricular circulatory assist system

DE-1
EN-1

Vk_20231101_01

Ortho Clinical Diagnostics

ORTHO VISION Analyser
Model: 6904579

ORTHO VISION Max Analyzer
Model: 6904578

ORTHO Optix Reader
Model: 6842223

IVD: Blood group/antibody screening analyser IVD

IVD: Blood group/antibody screening analyser IVD

IVD: Agglutination assay digital imaging reader/analyser IVD

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

Vk_20231031_25

Cook Endoscopy

Quantum TTC Biliary Balloon Dilator
Model: QBD-10X3, QBD-10X3-E, QBD-4X3, QBD-6X3, QBD-6X3-E, QBD-8X3, QBD-8X3-E
Lot: W4723306, W4724322, W4746517, W4753813, W4754251, W4754849, W4743607, W4743193, W4744876, W4749235, W4749746, W4751772, W4751907, W4751510

MD: EMDN=45712

EN-1

Vk_20231030_03

exocad GmbH

exoplan
Model: exoplan ; 2.3 Matera, 3.0 Galway, 3.1 Rijeka
Lot: See FSN
SW-Version: 2.3 , 3.0 3.1

MD: Dental treatment application software

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

Vk_20231101_10

Olympus Medical Systems Corp.

Flexible video bronchoscope, reusable
Model: see FSN
S/N: All

MD: bronchoscope

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

Vk_20231025_01

Ambu A/S

AMBU SPUR II
Model: 325002000
Lot: 1000771640
S/N: 1000771640

MD: Pulmonary resuscitator, manual, single-use

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

Vk_20231102_02

(Updated )

Covidien llc

McGRATH MAC Video Laryngoscope
Lot: See PSN

MD: Video Laryngoscopes

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

Vk_20231003_18

Carestream Health Inc

DRX-Revolution Mobile X-Ray System
Model: 1019397, 8610180
S/N: See FSN

MD: Mobile basic diagnostic x-ray system, digital

DE-1
IT-1

Vk_20231027_08

Olympus Medical Systems Corp.

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Model: GIF-1TH190; N4505840, N4505850
S/N: All

MD: Flexible video gastroduodenoscope

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

Vk_20231025_19

Epocal Inc.

epoc NXS Host
Model: 11413497 (EU), 11413518 (ROW)
S/N: all
SW-Version: From 4.9.4 to the current version 4.11.11.

IVD: Metabolic profile clinical chemistry analyser IVD

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

Vk_20231024_25

Philips Electronics Nederland B.V.

Philips Intera, Achieva, Ingenia CX
Model: see FSN

MD: Full-body MRI system, superconducting magnet

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

Vk_20231025_18

MAQUET Cardiopulmonary GmbH

CARDIOHELP-i
Model: 701048012; 701072780; 701052044; s. Model number
S/N: all

MD: Cardiopulmonary bypass system, roller type

DE-1
FR-1
EN-1

Vk_20231030_21

synedra information technologies GmbH

synedra View
Model: 22 “Niobe”, 23 “Selene”
SW-Version: All, 23.0.0.0

MD: Radiology picture archiving and communication system

DE-1
FR-1

Vk_20231024_30

Cepheid

Xpert Xpress CoV-2/Flu/RSV plus
Model: XP3COV2/FLU/RSV-10
Lot: All

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

DE-1
FR-1
IT-1

Vk_20231031_04

(Updated )

Megadyne Medical Products, Inc

Electrosurgical return electrode, reusable
Model: see FSN
Lot: see FSN

MD: Electrosurgical return electrode, reusable

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

Vk_20230605_25

Edwards Lifesciences LLC

TruWave DPT
Model: see FSN
Lot: see FSN

FloTrac sensor
Model: see FSN
Lot: see FSN

Acumen IQ Sensor
Model: see FSN
Lot: see FSN

MD: Invasive-pressure external transducer, single-use

MD: Invasive-pressure external transducer, single-use

MD: Invasive-pressure external transducer, single-use

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

Vk_20231005_04

(Updated )

Philips Electronics Nederland B.V.

Brilliance CT Big Bore
Model: 728242, 728243, 728244
S/N: 763006

MD: Full-body CT system

FR-1
EN-1

Vk_20231018_13

(Updated )

DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.

Phosphorus Inorganic, Molybdate
Model: D00359B, D00361, D00362, D00363, D00364, D0435917, D85911, DA0840, DB20329, DE1840, DT1040
Lot: 2156/925247

IVD: Phosphate inorganic / Phosphorus

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

Vk_20231016_05

(Updated )

Carestream Health Inc

DRX-Revolution Mobile X-Ray System
Model: 1019397
S/N: See FSN

MD: Mobile basic diagnostic x-ray system, digital

DE-1
IT-1

Vk_20231016_22

Dentalpoint AG

ZERAMEX® WB Gingivaformer, 4mm
Model: WB37504
Lot: 3056235

MD: Dental implant suprastructure, temporary, preformed, single-use

DE-1

Vk_20231019_13

Siemens Healthcare GmbH

ARTIS icono ceiling
Model: 4056869295923

MD: Stationary angiographic x-ray system, digital

DE-1
EN-1

Vk_20231017_06

(Updated )

exocad GmbH

exoplan
Model: 3.1 Rijeka
Lot: N/A
S/N: 8009E804, F2D48C50, 802A6C31, 8010B827, D7D49268, 8010D03A, 802A340C, E2D48F58, 802A4C05, 8010C015, 8010AC1D, 80109813, 8009C822, 8009FC07, Serial Numbers of exoplan 3.1 dongles active in Switzerland
SW-Version: EB 8423 (Main Release), 8587 (Service Release 1)

MD: Dental treatment application software

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

Vk_20230906_23

GROUPE SEBBIN SAS

Fat Washer 800
Lot: N010306

MD: Autologous adipose tissue collection/washing set

DE-1
FR-1
IT-1

Vk_20231023_02

Reison Medical AB

Anesthesia frame Carbon
Model: 10-313; reison product catalogue-MM001 Ver.04
Lot: 32597

MD: Respiratory And Anaesthesia Devices – Other

EN-1

Vk_20230907_07

Mazor Robotics Ltd.

Mazor X System
Model: TPL0059
S/N: All
SW-Version: 4.2.2 and 5.0.1

MD: Multi-purpose stereotactic surgery system

FR-1
EN-1

Vk_20231018_08

Elekta Limited

Linear Accelerator
S/N: Digital Linear Accelerators with SN up to and including SN 154584

MD: Linear accelerator system

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

Vk_20231018_14

Olympus Medical Systems Corp.

EVIS X1 VIDEO SYSTEM CENTER CV-1500
Model: CV-1500; N6011250
S/N: All

MD: Endoscopic video image processing/light source system

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

Vk_20231020_24

Philips Goldway (Shenzhen) Industrial Inc.

Philips HeartStart Intrepid Monitor/Defibrillator
Model: 867172
S/N: See UAL86100238

MD: Physiologic-monitoring defibrillation system

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

Vk_20231019_08

(Updated )

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: ORBIS Medication 03.17.00.00 or higher

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20231010_30

(Updated )

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: ORBIS Medication 03.18.02.00 or higher

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20231010_31

Abbott Diagnostics Scarborough, Inc.

ID NOW Instrument
Model: NAT-000, NAT-000S
S/N: All serial numbers with software version 7.0.0.20
SW-Version: 7.0.0.20

IVD: Isothermal nucleic acid amplification analyser IVD, laboratory

EN-1-e d f i

Vk_20231017_20

CareDx Pty Ltd

AlloSeq Assign
SW-Version: v1.0.3, v1.0.4, v1.0.5

IVD: Human genomic analysis interpretive software IVD

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

Vk_20231013_17

TEI Biosciences Inc.

TissueMend
Model: 6495-9-001; 6495-9-004; 6495-9-006
Lot: all

MD: Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

DE-1
EN-1

Vk_20231016_02

Medtronic Inc.

Mo.Ma Ultra Cerebral Protection Device
Model: MOM0130069X6, MOM0130068X5
Lot: 226373365, 226388209, 226403314, 226460841

MD: Intravascular Embolic Protection Catheters And Systems – Other

DE-1
FR-1
EN-1

Vk_20231012_12

Neuromedex GmbH

Medistrip
Model: 01.3200
Lot: 205119, 208238, 211093, 211240, 301163, 303179

MD: Stripper, vein

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

Vk_20231016_01

Philips Medical Systems

Xper Flex Cardio Physiomonitoring System
Model: FC2010 & FC2020

MD: General-purpose multi-parameter bedside monitor

DE-1
FR-1

Vk_20230907_08

Feather Safety Razor Co., LTD.

Standard Incision Scalpel
Model: 200200700, 200200715, 200200722, 200200730, 200200745, 200500745
Lot: see FSN

MD: Ophthalmic knife, single-use

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

Vk_20231006_20

(Updated )

Siemens Healthcare Diagnostics Inc.

Atellica CH 930 Analyzer
SW-Version: V1.25.1 and prior

IVD: Multiple clinical chemistry analyser IVD, laboratory

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

Vk_20211119_17

(Updated )

SENTINEL CH. S.p.A.

ALINITY C IRON (2300T)
Model: 08P3920
Lot: 21046Y600, 21118Y600, 30227Y600, 30302Y600

MLTGNT IRON (3060T)
Model: 6K95-41
Lot: 30610Y600

MLTGNT IRON (918T)
Model: 6K95-30
Lot: 21058Y600, 21101Y600, 30918Y600

IVD: Iron IVD, kit, enzyme spectrophotometry

IVD: Iron IVD, kit, enzyme spectrophotometry

IVD: Iron IVD, kit, enzyme spectrophotometry

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

Vk_20231003_13

St. Jude Medical

CardioMEMS Patient Electronic System
Model: CM1100
S/N: All serial numbers

AIMD: Implantable pulmonary artery pressure monitoring system

DE-1
DE-1_Patient
FR-1
FR-1_Patient
EN-1
EN-1_Patient

Vk_20231004_15

MAQUET Cardiopulmonary GmbH

CARDIOHELP Emergency Drive
Model: 701048002, 701076205
S/N: see FSN

MD: Cardiopulmonary bypass system, roller type

DE-1
EN-1

Vk_20231006_25

EOS imaging

oneFIT Knee Guide
Model: KIT0010, KIT0002
Lot: 230505, 230597, 230608, 230689, 230724, 230741, 230742, 230754, 230766, 230769, 230778, 230781, 230782, 230810, 230811, 230826, 230837, 230838, 230848, 230861, 230871, 230876, 230946, 230950, 230957, 230958, 230972, 230980, 231016, 231068
S/N: N/A
SW-Version: N/A

MD: EMDN=61781

DE-1
FR-1

Vk_20231009_16

Intuitive Surgical, Inc

Instrument Arm Drape
Model: 470015-07
Lot: DM3223602

MD: Medical equipment drape, single-use

DE-1
IT-1

Vk_20231005_26

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Venue go cart
S/N: see FSN

MD: General-purpose ultrasound imaging system

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

Vk_20231005_29

(Updated )

Roche Molecular Systems, Inc.

cobas SARS-CoV-2 & Influenza A/B
Model: 09233474190; 09446125190

cobas Influenza A/B & RSV UC
Model: 09233962190

IVD: SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20221227_01

Fresenius Medical Care AG & Co. KGaA

stay safe Disinfection Cap
Model: 2845091
S/N: 2845091

MD: Vascular catheter protective cap

DE-1
FR-1
IT-1

Vk_20230926_22

(Updated )

Ludwig Bertram GmbH

laguna Duschstuhl, laguna Duschhocker
Model: 78700 400, 78700 500, 78700 600, 78700 700
S/N: 00001935 to 00002874, 00001635 to 00001954, 00014658 to 00024391, 00008149 to 00015961

MD: Fixed And Rotary Chairs For Bath And Shower

DE-1
EN-1

Vk_20230922_12

Siemens Healthcare Diagnostics Inc.

RAPIDPoint 500e Blood Gas System
Model: 11416751; 11416752; 11416754; 11416755

RAPIDPoint 500 Blood Gas System
Model: 10492730; 10696855; 10696857; 10697306

IVD: Blood gas/haemoximetry analyser IVD, point-of-care

IVD: Blood gas/haemoximetry analyser IVD, point-of-care

DE-1
FR-1
IT-1

Vk_20230928_20

Boston Scientific Corporation

EXALT Model D Single-Use Duodenoscope
Lot: See FSN

MD: Flexible video duodenoscope, single-use

DE-1

Vk_20231003_02

Cetro Medical AB

Hegenberger Retractor
Model: A1390
Lot: 4227

MD: Retractor

EN-1

Vk_20231002_22

GE Healthcare

Centricity PACS
SW-Version: See FSN

Centricity Universal Viewer
SW-Version: See FSN

MD: Radiological PACS software

MD: Medical image management system

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

Vk_20231003_01

(Updated )

Olympus Medical Systems Corp.

Various Olympus endoscope models
Model: see FSN
S/N: All

MD: Flexible endoscope

DE-1
FR-1
IT-1

Vk_20230918_14