Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2024 – 30.09.2024 Швейцарія

(Updated )

Philips Respironics, Inc

Trilogy EV300

Trilogy Evo O2

Trilogy Evo

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_20240923_28

(Updated )

GE Healthcare

Centricity PACS

MD: Radiological PACS software

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

Vk_20240906_38

(Updated )

Philips Respironics, Inc

BiPAP A40 Pro
Model: see FSN

BiPAP A40 EFL
Model: see FSN

BiPAP A30 EFL
Model: see FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

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

Vk_20240708_09

(Updated )

Actim Oy

Actim Partus Test
Model: 31931ETAL
Lot: 2005341

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

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

Vk_20240923_07

(Updated )

iSTAR Medical SA

MINIject S
Model: FG2001ZA; FG2001ZB

MD: Glaucoma supraciliary implant

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

Vk_20240909_01

(Updated )

MAQUET Cardiopulmonary GmbH

MEERA operating table with autodrive
Model: FSN
S/N: FSN

MD: Universal operating table, electrohydraulic

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

Vk_20240913_03

Elekta Instrument AB

Disposable Biopsy Needle Kit
Model: 911933
Lot: 873874875R

MD: Neurological stereotactic surgery system

DE-1
FR-1
EN-1

Vk_20240923_30

Gyrus ACMI, Inc.

SG PK CUTTING FORCEPS
Model: TPK-CF0533; PK-CF0533
Lot: see FSN

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

DE-1
FR-1
EN-1

Vk_20240923_25

Smiths Medical ASD, Inc.

CADD-Solis Li-ion Rechargeable Battery Packs
Model: 21-2160-XX

MD: Portable/mobile rechargeable battery pack

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

Vk_20240923_24

(Updated )

Fujifilm Corporation

FDR Nano
Model: DR-XD 1000
S/N: All devices

MD: Mobile basic diagnostic x-ray system, digital

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

Vk_20240131_11

B-K Medical AS

Ultrasound system type 2300
Model: bk3000, bk3500, bk5000, bkActiv
S/N: 2300-11, 2300-61, 2300-66

MD: General-purpose ultrasound imaging system

DE-1
FR-1
IT-1

Vk_20240919_20

Medtronic Inc.

Recharger Kit
Model: RS6230, RS7230
S/N: see FSN

MD: Cerebral Implantable Neurostimulators - Accessories; Spinal Implantable Neurostimulators - Accessories

DE-1
FR-1
EN-1

Vk_20240918_08

(Updated )

Bordier Affinity Products SA

Strongyloides ratti IgG ELISA
Model: 9450
Lot: 2419S

IVD: Parasitology - Other

FR-1
EN-1

Vk_20240905_01

Olympus KeyMed KeyMed House, Stock Road

Olympus OFP-2 Flushing pump
Model: K10001143
S/N: 222331548, 22331366, 22332334

MD: Surgical irrigation pump

DE-1
EN-1

Vk_20240918_15

ICU Medical

CADD-Solis AC Adapter
Model: 21-0270-25

MD: Basic power supply, reusable

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

Vk_20240923_20

(Updated )

Covidien LLC

McGRATH MAC Video Laryngoscope
Model: 300-000-000, 301-000-000
S/N: 300-000-000: All serial numbers between 366170 to 405673; , 301-000-000: All serial numbers

MD: Video Laryngoscopes

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

Vk_20240725_25

(Updated )

Boston Scientific CRM

PROPONENT MRI
Model: L231
S/N: See FSN

ACCOLADE MRI
Model: L331
S/N: See FSN

ESSENTIO MRI
Model: L131
S/N: See FSN

AIMD: Dual-chamber implantable pacemaker, rate-responsive

AIMD: Dual-chamber implantable pacemaker, rate-responsive

AIMD: Dual-chamber implantable pacemaker, rate-responsive

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

Vk_20240913_76

Illumina, Inc

NovaSeq 6000Dx Instrument with DRAGEN Server
Model: 20068232

Illumina DRAGEN Server for NextSeq 550Dx
Model: 20086130

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

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

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

Vk_20240916_23

(Updated )

Tosoh Corporation

501RP+
Model: 0023295
Lot: N/A
S/N: N/A
SW-Version: v2.42 and previous versions

IVD: High Performance Liquid Chromatography Systems - Ivd Medical Device Software

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

Vk_20240913_29

(Updated )

Proteomedix AG

Proclarix Risk Calculator
Model: PCLX RICALI
SW-Version: V2.1.1 and V2.2.1

IVD: Mixed Panel Multiparameter Analysers - Ivd Medical Device Software

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

Vk_20240618_02

Abbott Molecular Inc.

Alinity m STI Amplification Kit
Model: 09N17-090; 09N17-091; 09N17-095 (US only)
Lot: all within date lot numbers

Alinity m HR HPV Amplification Kit
Model: 09N15-090; 09N15-091 (Canada only); 09N15-095 (US only)

Alinity m System
Model: 08N53-002; 08N53-032

IVD: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

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

DE-1
FR-1
EN-1

Vk_20240916_26

B. Braun Melsungen AG

Spaceplus Perfusor (with TOM functionality)
Model: 8719030
SW-Version: C02, C03, C04

MD: Bedside syringe pump

DE-1
FR-1
IT-1

Vk_20240906_26

Ambu A/S

Ambu VivaSight 2 DLT
Model: 412351000 , 412371000, 412391000, 412411000
Lot: see FSN

MD: Endobronchial tube

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

Vk_20240830_15

Olympus Medical Systems Corp.

EVIS X1 Bronchovideoscope
Model: BF-H1100, BF-1TH1100; N6130950, N6130650
S/N: Please refer to the spreadsheet with affected Serial Numbers submitted as a separate file

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Model: GIF-H190N; N5780950

EVIS EXERA III Small Intestinal Videoscope
Model: SIF-H190; N6130350

EVIS X1 Gastrointestinal Videoscope
Model: GIF-1100; N6019450

MD: Data management system

MD: Flexible video gastroduodenoscope

MD: Flexible video enteroscope

MD: Flexible video gastroduodenoscope

DE-1
FR-1
EN-1

Vk_20240913_77

(Updated )

Hologic, Inc.

Horizon DXA System
Model: Horizon A / Horizon C / Horizon W / Horizon Ci / Horizon Wi
S/N: see FSN

MD: Bone absorptiometric x-ray system, dual-energy

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

Vk_20240614_29

CODAN pvb Critical Care GmbH

Monitoring set, single, 9003, 3 ml/h, ABSS
Model: Monitoring Set, single; 74.6641
Lot: 983820, 984372

MD: Invasive Blood Pressure Monitoring Instruments

DE-1

Vk_20240913_55

(Updated )

SAV Liquid Production GmbH

Formaldehyde solution 4% buffered
Model: FN-60180-4-1; 87-0980-00-10024 (LA-BS-FN-120180-4-1), 87-0980-00-Neutral-D (LA-BS-FN-120180-4-2), 87-0980-00-Unilabs (LA-BS-FN-120180-4-3), 87-0980-00-Neutral-F (LA-BS-FN-120180-4-4), 87-0980-00-Neutral-I (LA-BS-FN-120180-4-5)
Lot: 12489964; 12498554, 12482100, 1248554

Formaldehyde solution 4.5% buffered
Model: FN-60180-45-1
Lot: 12443377

IVD: Fixing reagents (Histology/Cytology)

IVD: Fixing reagents (Histology/Cytology)

DE-1
FR-1
EN-1

Vk_20240904_22

Croma Pharma GmbH

NuVisc Pro
Model: 37284, 37758
Lot: all lots

MD: Vitreous/aqueous humour replacement medium, intraoperative

DE-1
FR-1
IT-1

Vk_20240906_34

(Updated )

Semeda GmbH

ALFA-Flex and BETA-Flex Brace
Lot: all devices delivered in the last 3 years

MD: Ankle-foot orthosis

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

Vk_20240731_26

Cefaly Technology

Cefaly Enhanced
Model: 10606
S/N: 6C06DA339415800251 to 6C06DA339415800500

MD: Tens System Electrodes

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

Vk_20240906_05

(Updated )

Smiths Medical ASD, Inc.

Portex Blue Line Siliconised PVC Tracheotomy Tube
Model: 100/506/040, 100/506/045, 100/506/050
Lot: see FSN

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

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

Vk_20240411_11

(Updated )

DH Healthcare GmbH

DeepUnity Diagnost
Model: see FSN
Lot: see FSN

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20240829_20

Boston Scientific Corporation

AVVIGO+ Multi-Modality Guidance System
Model: See FSN
Lot: See FSN
SW-Version: 3.0.1

MD: Cardiovascular ultrasound imaging system

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

Vk_20240906_17

Gyrus ACMI Inc.

Soltive Laser System
Model: TFL-SLS, TFL-PLS
S/N: All

MD: General/multiple surgical solid-state laser system

DE-1
FR-1

Vk_20240909_16

Shimadzu Corporation

SIL-40C X3 CL
Model: SIL-40C X3 CL; 228-65120-55
S/N: L2C306051006

SIL-40C XR CL

IVD: High performance liquid chromatography analyser IVD

IVD: High performance liquid chromatography analyser IVD

FR-1

Vk_20240906_21

DEHAS Medical Systems GmbH

QualityFlow flow meter
Model: DIN-connector
Lot: see FSN
S/N: see FSN

Quality Mix Flowmeter
Model: O2 3, 2-32 LPM
Lot: see FSN
S/N: see FSN

MD: Medical gas flowmeter, Thorpe tube

MD: Medical gas flowmeter, Thorpe tube

DE-1
EN-1

Vk_20240910_03

Fritz Stephan GmbH

Ventilator, Infant

MD: Ventilator, infant

EN-1

Vk_20240905_19

(Updated )

DH Healthcare GmbH

DeepUnity Viewer 2.x
Model: See FSN
Lot: See FSN

MD: Picture Archiving And Communication Systems

DE-1
FR-1

Vk_20240829_21

Philips Medical Systems

IntelliVue MX400-550
Model: 866060, 866061, 866062, 866064, 866066
Lot: Only MX400-550 devices shipped after 26-April-2024
S/N: see FSN

MD: Multiple vital physiological parameter monitoring system, clinical

DE-1
IT-1
EN-1

Vk_20240905_26

Qualigen, Inc.

FastPack TSH Calibrator Kit
Model: 25000024; 25000024
Lot: 2405017-1
S/N: n/a

IVD: Hormones/Standards Calibrators

EN-1

Vk_20240829_17

(Updated )

Abiomed Inc.

Impella 5.5 SmartAssist Heart Pump
Model: 0550-0007; 2000193; 2000154.; 0550-0002; 1000482; 0048-0014.
Lot: see FSN
S/N: see FSN
SW-Version: see FSN

Impella CP SmartAssist
Model: 0550-0007; 2000193; 2000154.; 0550-0002; 1000482; 0048-0014.
Lot: see FSN
S/N: see FSN
SW-Version: see FSN

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

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

Vk_20240729_01

CODAN ARGUS AG

CODAN ARGUS 718 V
Model: 601349

CODAN ARGUS 717 V
Model: 601268
S/N: all

MD: Bedside infusion pump, single-channel

MD: Bedside infusion pump, single-channel

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

Vk_20240826_09

Smiths Medical ASD, Inc.

CADD Medication Cassette Reservoir
Model: 21-7001-24, 21-7002-24, 21-7301-24, 21-7302-24
Lot: see FSN

MD: Infusion pump cassette

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

Vk_20240902_14

(Updated )

Abbott Ireland Diagnostic Division

Alinity i HBsAg Controls
Model: 08P0810
Lot: 59044FZ00

ARCHITECT HBsAg Controls
Model: 6C36-10
Lot: 60109FZ00, 59039FZ00

IVD: Hepatitis B virus surface antigen IVD, control

IVD: Hepatitis B virus surface antigen IVD, control

DE-1
EN-1

Vk_20240828_27

Bohus BioTech AB

Minivisc Plus
Model: 1183, 1184
Lot: MPFX16100, MPFX17100

MD: Ophthalmology, Hyaluronic Acid And Derivatives

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

Vk_20240830_14

GE Healthcare GmbH

ViewPoint
SW-Version: v5, v6

MD: Radiological PACS software

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

Vk_20240827_09

Medtronic Navigation Inc.

Software App 9735762 Stealth S8 Application
Model: 9735762
S/N: All
SW-Version: 1.3.0 and 1.3.2

MD: Multi-purpose stereotactic surgery system

DE-1
EN-1

Vk_20240828_28

Paradigm Spine GmbH

HPS 2.0 Rod coupler
Model: HBI92527
Lot: 1321000344, 1321000352, 1322000026, 1322000072, 1322000073, 1322000074, 1322000075

MD: Spinal dynamic-stabilization system

DE-1
FR-1
IT-1

Vk_20240828_29

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur anti-TPO (aTPO) Assay anti-TPO (aTPO) Assay
Model: 10630886 (100T), 10630887 (500T)
Lot: 26053337, 26054337, 26051337, 26052337

Atellica IM Anti-Thyroid Peroxidase (aTPO) Assay
Model: 10995466 (100T), 10995467 (500T)
Lot: 26098336, 26099336

IVD: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

IVD: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

DE-1-AtellicaIM
FR-1-AdivaCentaur
FR-1-AtellicaIM
EN-1-AdivaCentaur
EN-1-AtellicaIM

Vk_20240827_11

BIOTRH s.r.o

Los Deline
Model: Los Deline 100g
Lot: See FSN

MD: Dermal tissue reconstructive material, synthetic polymer, bioabsorbable

EN-1

Vk_20240828_24

Immunotech S.A.S.

Access TSH (3rd IS) reagent pack
Model: C28643
Lot: 339117, 338724, 439341, 338367, 338057, 234251

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

DE-1
EN-1

Vk_20240830_10

Philips Medical Systems Nederland B.V.

Ingenia with Evolution Upgrade
Model: see FSN

Ingenia 1.5T and 3.0T
Model: see FSN

Ingenia Ambition S
Model: see FSN

Ingenia Ambition X
Model: see FSN

Philips Ingenia Elition
Model: see FSN

Ingenia & SmartPath to dStream MRI
Model: see FSN

MR 5300
Model: see FSN

MR 7700
Model: see FSN

SmartPath to Ingenia Elition X
Model: see FSN

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

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

MD: Full-body MRI system, superconducting magnet

DE-1
EN-1

Vk_20240902_18

(Updated )

Miltenyi Biotec B.V. & Co. KG

LIFE 21 apheresis unit
Model: 330-000-621, 330-000-622

MD: Apheresis system

DE-1
FR-1
EN-1

Vk_20240902_05

Waldemar Link GmbH & Co. KG

Universal Handle, Stainless Steel, straight
Model: 130-394/01
Lot: C204156, C204157, C204158, C208135, C208136, C219063, C219064, C233031, C233033, C233034, C332135, C332136, C332137, C335006

MD: Surgical instrument handle, non-torque-limiting

DE-1
FR-1
EN-1

Vk_20240902_19

Emo-Flüssigkeit A.G.

SQUID 3ML kit
Model: See FSN
Lot: See FSN

MD: Embolization implant kit

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

Vk_20240826_32

(Updated )

CareDx Pty Ltd

AlloSeq HCT Software
Model: ASHCTS2
SW-Version: v2.2.0, v2.2.1

IVD: Post bone-marrow transplant engraftment study IVD, kit, nucleic acid technique (NAT)

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

Vk_20240726_35

(Updated )

Smith & Nephew, Inc.

REGENETEN TENDON ANCHORS
Model: 72205201, 2504-1
Lot: See FSN

MD: Soft-tissue/mesh anchor, bioabsorbable

FR-1
IT-1
EN-1

Vk_20240813_23

(Updated )

The Surgical Company International B.V.

Fluido Trauma set/ Fluido Standard set
Model: 671500/671200
Lot: all non-expired devices

MD: Radiation blood/fluid warmer intravenous set

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

Vk_20240819_04

Medtronic Inc.

Vanta with AdaptiveStim Technology Primary cell neurostimulator
Model: 977006
S/N: All

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

DE-1
FR-1

Vk_20240820_22

Siemens Medical Solutions USA Inc.

ACUSON Redwood ultrasound system
Model: 11503314
S/N: see FSN

MD: General-purpose ultrasound imaging system

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

Vk_20240820_23

Siemens Medical Solutions USA Inc.

ACUSON Maple/Maple Select ultrasound system
Model: 11711750, 11711779

MD: General-purpose ultrasound imaging system

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

Vk_20240821_09

GS Elektromedizinische Geräte G. Stemple GmbH

Battery corpuls cpr (LiPo)
Model: 09120 / 09120
S/N: 150000207 to 241500195
SW-Version: all, including 1.4-005

MD: Secondary battery

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

Vk_20240820_06

Philips Medical Systems Nederland B.V.

Azurion
Model: see FSN

Allura Xper
Model: see FSN

Integris
Model: see FSN

Multi Diagnost Eleva
Model: see FSN

MD: Stationary angiographic x-ray system, digital

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

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

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

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

Vk_20240827_01

Siemens Healthcare Diagnostics Manufacturing Limited

Atellica CH Microalbumin_2 (microALB_2) Reagents
Model: 11097610
Lot: 232033, 232128, 232137, 232146, 232147, 242149, 242150, 242365
S/N: N/A

ADVIA Chemistry Microalbumin_2 (microALB_2) Reagents
Model: 10318197
Lot: 612528, 616644, 620971, 623768, 636498, 640513, 658356, 668872
S/N: N/A

IVD: Microalbumin IVD, kit, nephelometry/turbidimetry

IVD: Microalbumin IVD, kit, nephelometry/turbidimetry

DE-1 (Atellica)
FR-1 (Atellica)
IT-1 (Atellica)
EN-1 (ADVIA)
EN-1 (Atellica)

Vk_20240820_24

Dominion Biologicals Limited

NOVACLONE Anti-D IgM + IgG Monoclonal Blend
Model: 0066037
Lot: 517279

IVD: Rhesus Typing

DE-1
EN-1

Vk_20240822_01

Alcon Laboratories, Inc.

DAILIES Total 1

TOTAL30 soft

MD: Soft corrective contact lens, daily-disposable

MD: Contact Lenses

DE-1
FR-1
IT-1

Vk_20240814_07

Instrumentation Laboratory Co.

HemosIL AcuStar ADAMTS 13
Model: 0009802048; 0009802048
Lot: All in date

IVD: Coagulation Factors - Other

EN-1

Vk_20240820_25

bioMérieux SA

VIDAS CK-MB
Model: 30421
Lot: 1010473720
S/N: N/A
SW-Version: N/A

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

DE-1
FR-1
EN-1

Vk_20240819_08

GE Hualun Medical Systems Co Ltd

Proteus XR/a
S/N: all

MD: Vascular spatula

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

Vk_20240730_11

Datex-Ohmeda Inc.

Aisys CS2, Avance CS2, Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900, and Aespire 7100 anesthesia devices equipped with the Auxiliary Common Gas Outlet (ACGO)

MD: Anaesthesia workstation, general-purpose

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

Vk_20240819_23

MAQUET Cardiopulmonary GmbH

Serial interface cable (RS232)
Model: 701075475; 701075475
Lot: see FSN

MD: Cardiopulmonary bypass system, roller type

DE-1
EN-1

Vk_20240813_11

bioMérieux SA

VIDAS DENGUE NS1 Ag
Model: 423077
Lot: 1010311970, 1010360350, 1010360380, 1010449760, 1010550540, 1010652000, 1010696870, 1010772810
S/N: N/A
SW-Version: N/A

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

DE-1
FR-1
EN-1

Vk_20240813_17

DH Healthcare GmbH

DeepUnity Diagnost

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20240819_24

DH Healthcare GmbH

DeepUnity Viewer 2.x

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20240819_26

(Updated )

MAQUET Cardiopulmonary GmbH

S 0283#Kardioplegie-Set
Model: 701005342
Lot: 3000302064, 3000355945

MD: Cardiopulmonary bypass system blood tubing set

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

Vk_20240808_14

Olympus Medical Systems Corp.

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

MD: Laparoscopic insufflator

DE-1
FR-1
IT-1

Vk_20240814_22

(Updated )

DiaSorin Inc

LIAISON Testosterone xt
Model: 318410
Lot: 136248, 136663, 136663A, 136842, 136981, 136981A, 136981B

IVD: Total testosterone IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20240812_22

Smiths Medical ASD, Inc.

BLUSelect, BLUgriggs and BLUperc Trach products
Model: see FSN
Lot: see FSN

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

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

Vk_20240812_09

(Updated )

Alcon Laboratories, Inc.

20G MVR+ V-Lance Ophthalmic knife
Model: see attached
Lot: see attached
SW-Version: N/A

ClearCut knive
Model: see attached; see attached
Lot: see attached
S/N: N/A
SW-Version: N/A

MD: Ophthalmic knife, single-use

MD: Ophthalmic knife, single-use

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

Vk_20240430_19

(Updated )

Contract Medical International GmbH

Blueflow Venous Stent devices
Model: FG-02234-004A; VS14150
Lot: 900066

MD: Venous endovascular stent-graft

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

Vk_20240726_29

Diagnostic Grifols SA

Erytra Eflexis
Model: 210600
SW-Version: from 1.2.0 to 3.1.0 (included)

IVD: Blood group/antibody screening analyser IVD

DE-1
FR-1
EN-1

Vk_20240816_08

Becton, Dickinson and Company, BD Biosciences

BD FACSDuet Premium Sample Preparation System
Model: 666339, 662588
S/N: All serial numbers with BD FACSDuet software version 1.4.1

IVD: Autosamplers

FR-1
EN-1

Vk_20240807_22

Unintech GmbH

Stirnfräser
Model: UNT-III-177588
Lot: 2301

MD: Orthopaedic instrument cleaning tool

DE-1
EN-1

Vk_20240812_20

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.19.x

MD: General Medicine Instruments - Other

DE-1
FR-1
EN-1

Vk_20240808_18

(Updated )

Bauerfeind AG

VenoTrain
Model: See FSN
Lot: see FSN

LumboTrain
Model: See FSN
Lot: See FSN

GenuTrain
Model: see FSN
Lot: see FSN

Sports Compression Ankle Support
Model: See FSN
Lot: See FSN

OmoTrain
Model: See FSN
Lot: See FSN

MD: Single-chamber venous compression system garment, reusable

MD: Lumbar spine orthosis

MD: Knee support orthosis

MD: Ankle/foot orthosis

MD: Shoulder immobilizer/orthosis, reusable

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

Vk_20240703_04

(Updated )

Ecolab Deutschland GmbH

Olympus EndoDis Pro
Model: 3099120, WD00342A; 3100780, WD00347A
Lot: 2243AP0104, 5233AP0204, 3293AP0104, 3293AP0204, 2034AP0204

MD: Disinfectants, Antiseptics, Sterilising Agents And Detergents For Medical Devices - Other

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

Vk_20240711_12

(Updated )

Abiomed Inc.

Impella CP
Model: 0048-0008; 0048-0002

Impella 5.5 SmartAssist Heart Pump
Model: 0550-0007, 2000193; 0550-0002, 1000482

Impella 5.0 Heart Pump
Model: 0046-3114; 005060

Impella LD
Model: 004681; 005080

Impella CP SmartAssist
Model: 2000154; 0048-0014

Impella 2.5
Model: 0046-3061; 005040

Impella RP
Model: 0046-3107; 0046-0011

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

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

Vk_20240220_02

GE Healthcare

Centricity Universal Viewer Zero Footprint Client
SW-Version: v6.0 SP9.x through SP10.x

MD: Medical image management system

DE-1
FR-1
IT-1

Vk_20240807_14

Philips Medical Systems Nederland B.V.

Philips Azurion system
Model: 722079, 722224;

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

DE-1
FR-1
EN-1

Vk_20240813_01

Össur hf.

Miami J Select Collar set
Model: MJSR-101
Lot: MX220516 to MX230104

Miami J Select Collar
Model: MJS-101
Lot: MX220516 to MX230104

MD: Cervical spine collar, reusable

MD: Cervical spine collar, reusable

DE-1
FR-1
IT-1

Vk_20240807_19

Meierhofer Medizintechnik GmbH

M-PDMS
SW-Version: 3.2.x, 3.3.x

MD: Various Instruments To Support And Monitor Vital Signs - Medical Device Software

DE-1

Vk_20240807_17

Nutricia Medical Devices BV

Flocare Infinity III
Model: 621825
Lot: plug head KRAD28H
S/N: 202316612104 to 202328312208

MD: Enteral feeding pump

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

Vk_20240808_16

Boston Scientific Neuromodulation Corporation

Vercise Genus
Model: M365DB12160, M365DB12320
S/N: All

AIMD: Deep brain electrical stimulation system

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

Vk_20240808_27

(Updated )

Welch Allyn, Inc.

Braun PRO 6000
Model: 06000-200, 06000-300
S/N: All

MD: Infrared patient thermometer, ear

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

Vk_20240626_11

Philips Goldway (Shenzhen) Industrial Inc.

Philips HeartStart Intrepid Monitor/Defibrillator
Model: 867172

MD: Physiologic-monitoring defibrillation system

EN-1

Vk_20240802_24

(Updated )

Sysmex Corporation

XF-1600
Model: AD629376
S/N: all
SW-Version: 8, 9 and 10

IVD: Flow cytometry analyser IVD

DE-1
FR-1
EN-1

Vk_20240805_14

Allurion Technologies, Inc.

Allurion Device/Elipse Gastric Balloon System 10D
Model: 10D-CE

MD: Appetite-suppression gastric balloon

DE-1
FR-1
EN-1

Vk_20240424_05

mySugr GmbH

mySugr Bolus Calculator

MD: Infusion Instruments - Software Accessories

DE-1
FR-1
IT-1

Vk_20240725_28

(Updated )

Stryker Instruments

Precision Round, Distal Bend
Model: see FSN
Lot: see FSN

MD: Cranial bur, single-use

DE-1
FR-1
EN-1

Vk_20240806_20

(Updated )

Carl Reiner GmbH

EasyConnect Adapter for 2 to 4 Lumen Jet Catheter
Model: CTNI-610-400
Lot: 2146

MD: Naso-oropharyngeal Tubes - Other

DE-1
EN-1

Vk_20240709_09

(Updated )

Argon Medical Devices Inc.

TruCore II
Model: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X
Lot: See FSN

Biopince
Model: 360-1080-01, 360-1580-01, 360-2080-01, 370-1080-01, 370-1580-01
Lot: See FSN

BioPinceUltra
Model: 360-1080-02, 360-1080-03, 360-1580-02, 360-1580-03, 360-2080-02, 360-2080-03, 370-1080-02, 370-1080-03, 370-1580-02, 370-1580-03
Lot: See FSN

MD: End-cut biopsy gun handpiece/needle

MD: End-cut biopsy gun handpiece/needle

MD: End-cut biopsy gun handpiece/needle

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

Vk_20240711_20

(Updated )

Biomedical Data Solutions Limited

NAT Manager
Model: 740648, 741722, 741495, 741496, 741497, 741498, 741521
SW-Version: 1.2, 1.4

IVD: Various General Purpose Ivd Instruments - Software Accessories

DE-1
DE-2
DE-3
DE-4
IT-2
IT-3

Vk_20240722_23

Bohus BioTech AB

Minivisc Plus
Lot: MPFX09100

MD: Eye lubricant

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

Vk_20240805_19

(Updated )

ConvaTec Limited

Kaltostat Dressing
Model: 1203783, 1226681, 1052788
Lot: 4E05238 , 4E05398 , 4E06012

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

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

Vk_20240719_13

Boston Scientific Corporation

Agile Esophageal Stent Systems
Model: See FSN
Lot: See FSN
S/N: See FSN

Wallflex Esophageal Stent Systems
Model: See FSN
Lot: See FSN
S/N: See FSN

MD: Polymer-metal oesophageal stent, non-sterile

MD: Polymer-metal oesophageal stent, non-sterile

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

Vk_20240801_22

(Updated )

Thuasne

Globe-Trotter blue/grey
Model: W2016021010, W2016022010
Lot: since 02/2021

Globe-Trotter+
Model: W2017021006
Lot: since 02/2021

MD: Forearm support crutch

MD: Forearm support crutch

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

Vk_20240705_07

Siemens Healthcare Diagnostics Manufacturing Limited

Atellica CH Urinary/Cerebrospinal Fluid Protein
Model: 11097543
Lot: 130414

IVD: Total protein IVD, kit, enzyme spectrophotometry

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

Vk_20240801_06

Ortho Clinical Diagnostics

ORTHO Optix Reader
Model: 6842223
SW-Version: V2.0.0.2870

IVD: Agglutination assay digital imaging reader/analyser IVD

EN-1

Vk_20240802_02

Medline International France SAS

Delivery Sets
Model: see FSN
Lot: see FSN

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

DE-1
FR-1
EN-1

Vk_20240726_26

Siemens Healthcare Diagnostics Inc.

Atellica IM CA 19-9 Assay
Model: 10995490, 10995489
Lot: 55974535, 55975535, 55977535

ADVIA Centaur CA 19-9 Assay
Model: 10491379, 10491244
Lot: 55970535, 55970535, 55971535, 55972535, 55973535

IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
EN-1

Vk_20240801_04

(Updated )

Beckman Coulter Ireland, Inc.

IRISpec CA/CB/CC
Model: 800-7702; 800-7211
Lot: 432-24 and higher; 432-24 and higher

IVD: Controls/standards/calibrators Clinical Chemistry

DE-1
FR-1
EN-1

Vk_20240726_02

Eurobio Scientific SA

EurobioPlex HEV
Model: EBX-010-50, EBX-010-100
Lot: 405003, 015609, 019712, 034523, 405103, 015709, 034623, EBX-010-100, 405003, 019712, 405103, 015709, 015609, 034523, 034623

IVD: Hepatitis E Virus - Na Reagents

EN-1

Vk_20240723_06

(Updated )

Medtronic MiniMed

MiniMed 640G Insulin Pump
Model: see FSN
S/N: All

MiniMed 670G Insulin Pump
Model: see FSN
S/N: All

MiniMed 720G Insulin Pump
Model: see FSN
S/N: All

MiniMed 740G Insulin Pump
Model: see FSN
S/N: All

MiniMed 770G Insulin Pump
Model: see FSN
S/N: All

MiniMed 780G Insulin Pump
Model: see FSN
S/N: All

MD: Ambulatory insulin infusion pump, electronic

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

MD: Ambulatory insulin infusion pump, electronic, non-software-dosing

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

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

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

DE-1
DE-2
DE-3_HCP
DE-3_PAT1
DE-3_PAT2
DE-3_PAT3
FR-1
FR-2
FR-3_HCP
FR-3_PAT1
FR-3_PAT2
FR-3_PAT3
IT-1
IT-2
IT-3_HCP
IT-3_PAT1
IT-3_PAT2
IT-3_PAT3
EN-1
EN-2
EN-3_HCP
EN-3_PAT1
EN-3_PAT2
EN-3_PAT3

Vk_20220525_17

(Updated )

Shenzhen Med-Link Elelctronics Tech Co.,LTD.

SPO2 Sensor
Model: S0026M-L; S0190M-LP
Lot: JA20230610008

MD: Pulse oximeter, line-powered

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

Vk_20240628_34

Philips Respironics, Inc

Trilogy Evo O2
Model: All (see FSN)
Lot: All (see FSN)
S/N: All (see FSN)
SW-Version: see FSN

Trilogy EV300
Model: All (see FSN)
Lot: All (see FSN)
S/N: All (see FSN)
SW-Version: see FSN

Trilogy Evo
Model: All (see FSN)
Lot: All (see FSN)
S/N: All (see FSN)
SW-Version: see FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

DE-1
FR-1
IT-1

Vk_20240715_22

Löwenstein Medical Technology GmbH + Co. KG

LUISA (LM150TD)
S/N: all

TIVAN LS
S/N: all

Life One
S/N: all

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

DE-1
FR-1
IT-1

Vk_20240729_53

HumanOptics Holding AG

IOL models in "Safeloader" (SL) packaging (Aspira-aA, Aspira-aA, Aspira-aAY, Aspira-aAY, Diff-aA, Diff-aAY, Aspira-aXAY, Aspira-aXA, Triva-aAY)
Model: 00084453, 00087450, 00084353, 00087350, 00085150, 00085250, 00087550, 00087950, 00088650

MD: Intraocular lens, Posterior Chamber, Hydrophilic Acrylic (different models with the same packaging type (SL))

DE-1
FR-1

Vk_20240711_03

Andersen Caledonia

SP Eye Sharps Safe Intravitreal Injection Needle
Model: SPY 712
Lot: N011169

MD: Ophthalmic needle, single-use

EN-1

Vk_20240730_02

Life Vascular Devices Biotech, S.L.

iVascular sergeant
Model: DSPC18065001, DSPC18090001, DSPC18130001, DSPC18150001, DSPC18065002, DSPC18090002, DSPC18130002, DSPC18150002

MD: Peripheral vascular catheter

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

Vk_20240718_30

ZEVEX Inc.

FreeGo enteral feeding pump
Model: S400
S/N: All

MD: Enteral feeding pump

DE-1
FR-1
IT-1

Vk_20240726_01

Schiller AG

CARDIOVIT AT-180
Model: 3.920570 / 0A.110000
Lot: N/A not lot/batch number related
S/N: N/A not serial number related
SW-Version: All software versions

MD: Electrocardiograph, professional, multichannel

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

Vk_20240723_27

(Updated )

Abbott Medical

HeartMate 3 System Controller
Model: 106524INT, 106531INT, 106531LF2
S/N: Specific serial numbers of the HeartMate3 LVAS kit (model: 106524INT) and the HeartMate 3 System Controller (model: 106531INT, 106531LF2) distributed since March 2024.
SW-Version: N/A

AIMD: Implantable ventricular circulatory assist system control unit

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

Vk_20240724_12

AI DE Diagnostic Co., LDT

Primeview HCG mini

IVD: HCG pregnancy test

FR-1 - DE-1 - IT-1

Vk_20240711_21

(Updated )

Philips Electronics Nederland B.V.

Philips Intera, Achieva, Ingenia CX
Model: see FSN

MD: Full-body MRI system, superconducting magnet

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

Vk_20231025_18

Beckman Coulter , Inc.

Access HBc Ab Reagent
Model: 34240
Lot: see FSN

IVD: Hepatitis B Core Antibody (total)

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

Vk_20240611_17

DT MedTech LLC

Hintermann Series H3 Total Ankle Replacement (TAR) System
Model: see FSN

MD: Coated ankle tibia prosthesis

EN-1-DIST
EN-1-HCP

Vk_20240310_11

(Updated )

Shenzhen Besdata Technology Co., Ltd

Automated External Defibrillator
Model: BeneHeart C1A; BeneHeart C2

MD: Non-rechargeable public automated external defibrillator

DE-1
FR-1
EN-1

Vk_20240626_21

Beckman Coulter , Inc.

DxI 9000 Access Immunoassay Analyzer
Model: C11137
S/N: Please refer to the FSN 24041 letter.

IVD: Chemiluminescent immunoassay analyser IVD

DE-1
EN-1

Vk_20240716_24

(Updated )

HumanTech Germany

Venus
Model: VL-RC-5-4, VL-RC-5-5, VL-RC-5-6, VL-RC-5-7, VL-RC-5-8, VL-RS-5-4, VL-RS-5-5, VL-RS-5-9
Lot: H1246QJ, H1305QK, H1330QJ, H1137QJ, H1409QI, H1222QJ, H1325QI, H1324QI, H1327QI

MD: Bone-screw internal spinal fixation system, sterile

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

Vk_20240701_15

(Updated )

tecfor care GmbH

Ecofit Xtra 120
Model: see FSN
S/N: all serial number from 21 0000000000, to 23 9999999999

Ecofit Xtra 140
Model: see FSN
S/N: all serial number from 21 0000000000, to 23 9999999999

MD: Electrical assistive bed

MD: Electrical assistive bed

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

Vk_20240527_15

(Updated )

Biokit S.A.

Alinity c Proteins Standard
Model: 3029-2128 (O8P67-01)
Lot: 01594L823

IVD: Plasma protein IVD, calibrator

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

Vk_20240704_16

(Updated )

Ventana Medical Systems, Inc

VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary
Model: 05857856001
Lot: J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, M00669

IVD: Primary Antisera For Immunohistology

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

Vk_20240704_01

Boston Scientific Neuromodulation Corporation

WaveWriter Alpha
Model: SC-1216 and SC-1232
S/N: WAVEWRITER ALPHA 16 IPG KIT: 100188 to 758920; WAVEWRITER ALPHA 32 IPG KIT: 100635 to 759404

AIMD: Analgesic spinal cord electrical stimulation system

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

Vk_20240717_21

Leonhard Lang GmbH

corPatch easy pediatric
Lot: see attached FSN
SW-Version: 05120.3

corPatch easy
Lot: see attached FSN
SW-Version: 04324.3

corPatch easy pre-connected
Lot: see attached FSN
SW-Version: 05120.1

MD: Multifunction cardiac electrode, paediatric

MD: Multifunction cardiac electrode, adult

MD: Multifunction cardiac electrode, adult

DE-1
EN-1

Vk_20240717_17

Bausch & Lomb GmbH

Corneal Irrigator
Model: 82020S; 82020S
Lot: Lots from Juli 2023 to November 2023 were affected (see attached Locator list)
S/N: N/A
SW-Version: N/A

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

DE-1
FR-1
IT-1

Vk_20240716_22

(Updated )

tecfor care GmbH

Ecofit
Model: see FSN
S/N: all serial numbers from 21 0000000000 to 23 9999999999

MD: Electrical assistive bed

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

Vk_20240506_21

Dräger Safety AG & Co. KGaA

Alcotest 7000 charging cradle
Model: 3700420 (3700399)

MD: Analyzers, Point-of-Care, Breath, Alcohol

EN-1

Vk_20240722_16

Ziehm Imaging GmbH

Ziehm 8000
S/N: 82975

Ziehm Solo
S/N: 55237, 55252, 55182, 55140, 54973, 54955, 54927, 55064

Ziehm Solo FD
S/N: 55277, 55203, 55196, 55113, 55092, 55045, 55042, 55041, 55035, 55018, 54984, 54905, 54835

Ziehm Vision RFD 3D
S/N: 23388, 23387, 23371

Ziehm Vision FD
S/N: 93634, 93633, 93632, 93596, 93592, 93551, 93550, 93549, 93548, 93546, 93545, 93537, 93450, 93449, 93448, 93436

Ziehm Compact
S/N: 80374

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

MD: Radiographic/fluoroscopic unit, general-purpose

MD: Various Instruments For Radiodiagnostics And Interventional Procedures

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

MD: Various Instruments For Radiodiagnostics And Interventional Procedures

MD: Basic diagnostic x-ray system

DE-1
FR-1
IT-1

Vk_20240711_13

RAL Diagnostics

RAL Diff-Quik Fixative solution
Model: 720560-2500
Lot: M76234

IVD: Haematology Stains For Microscopy - Other

DE-1
FR-1
EN-1

Vk_20240719_01

Beckman Coulter Ireland, Inc.

IRISpec CA/CB/CC
Model: 800-7702
Lot: Lot 432-24 and higher.

IVD: Controls/standards/calibrators Clinical Chemistry

DE-1
FR-1
EN-1

Vk_20240723_05

(Updated )

D-tek SA

NDH Chromatin + DFS70 DOT for BDI
Model: AD-NDHDFSDBD
Lot: FA240518

IVD: Autoimmune Disease Tdm

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

Vk_20240704_02

Baxter Medical Systems GmbH + Co. KG

Präzisionschirurgietisch PST 500 U
Model: 4080100
Lot: 00887761973466
S/N: See FSN

MD: Universal operating table, electromechanical

DE-1

Vk_20240703_37

(Updated )

Bruker Daltonics GmbH & Co. KG

UMIC Colistin
Model: UM-COL-040
Lot: 240410COL, 240418COL, 240506COL

IVD: Antibacterial minimum inhibitory concentration (MIC) IVD

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

Vk_20240712_19

(Updated )

Smiths Medical ASD, Inc.

Administration sets used with CADD pumps
Model: See FSN
Lot: See FSN

Medication cassette reservoirs with Flow Stop
Model: See FSN
Lot: See FSN

MD: Electric infusion pump administration set, single-use

MD: Infusion pump cassette

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_20221213_23

(Updated )

Medtronic Inc.

CareLink Programmer
Model: 2090
S/N: All with prefixes PKK0 and PKK1
SW-Version: 3.2 or higher

AIMD: Cardiac pulse generator programmer

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

Vk_20240710_35

Becton, Dickinson and Company

BD BACTEC MGIT 960 PZA Kit
Model: See FSN
Lot: See FSN

IVD: Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

DE-1
FR-1

Vk_20240715_28

(Updated )

CAPRON PODOLOGIE

Chairs F1 2000, F1 2000 Ergo, F1 Neo, F1 Neo Ergo, F1 3000, F1 3000 Ergo
Model: see FSN
S/N: All Serial numbers are involved

MD: Electric Medical Chairs - Other

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

Vk_20240620_28

(Updated )

MAQUET Cardiopulmonary GmbH

all Maquet Cardiopulmonary GmbH products containing the component vacuum-tight reservoir (VHK 71000)
Model: two variations: Stand-Alone reservoir (VHK-Reservoir) or Integrated with Oxygenators (VKMO) - see FSN
Lot: see FSN

MD: Reservoir used to collect, store and filter blood for up to six hours in the extracorporeal circuit during cardiopulmonary bypass operations on adult patients, with or without vacuum-assisted venous return.

DE-1
FR-1
EN-1

Vk_20240711_02

(Updated )

Medivance, Inc.

Arctic Sun Temperature Management System
Model: See FSN
S/N: All

MD: External circulating-fluid core temperature regulation system control unit, heating/cooling

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

Vk_20240625_21

(Updated )

Medtronic Inc.

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

Vk_20230510_21

Medtronic Inc.

DLP Single Stage Venous Cannulae
Model: 67312
Lot: 2023090954, 202312C065

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

DE-1
EN-1

Vk_20240709_15

Philips Medical Systems Nederland B.V.

Philips Azurion R1.x
Model: 722063, 722064, 722067, 722068, 722078, 722079
S/N: see FSN
SW-Version: R1.x

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

DE-1
FR-1
EN-1

Vk_20240715_26

(Updated )

ACUTRONIC Medical Systems AG

Fabian HFO
Model: 112001
S/N: All SN updated to SW V5.2.2
SW-Version: SW V5.2.2

fabian HFOi Ventilator
Model: 113001
S/N: All SN updated to SW V5.2.2
SW-Version: SW V5.2.2

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_20240410_03

Philips Goldway (Shenzhen) Industrial Inc.

HeartStart Intrepid Monitor/Defibrillator
Model: 867172
S/N: see FSN

MD: Rechargeable professional automated external defibrillator

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

Vk_20240710_36

(Updated )

Medtronic Xomed Inc

EMG TUBE REINFORCED 6MM / PRO PIN; EMG TUBE REINFORCED 7MM / PRO PIN (1/EA); EMG TUBE REINFORCED 8MM / PRO PIN (1/EA)
Model: 8229306, 8229307, 8229308
Lot: all

ENDOTRACHEAL TUBE 6MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 7MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 8MM EMG CONTACT (1/EA)
Model: 8229506, 8229507, 8229508

MD: Reinforced endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

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_20220506_10

General Medical Merate S.p.A.

Opera T90SH; Opera T90SHX
Lot: See FSN
S/N: See FSN

MD: Tilting Tables For Radiology Equipment

FR-1

Vk_20240625_25

(Updated )

Myriad International GmbH

EndoPredict QS Kit Uno & EndoPredict QS Kit Duo
Model: SVQ33F; SVQ350 / SVQ360
Lot: OF10022, OF10024

IVD: Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

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

Vk_20240626_28

AIR LIQUIDE MEDICAL SYSTEMS

SELECTAFLO
Model: SELECTAFLO FORMER GENERATION; CM064400 / CM064500 / CM066500 / CM067400 / CM067500 / CM074600 / CM074800 / CM164400 / CM164500 / CM166500 / CM167400 / CM167500 / CM171400 / CM172700 / CM174400
S/N: All devices put in the market between 1999 and 2012

MD: Medical gas flowmeter, dial-type

DE-1
FR-1
EN-1

Vk_20240710_18

BioFire Diagnostics, LLC

FilmArray Gastrointestinal (GI) Panel
Model: RFIT-ASY-0116 (GI, 30-pack) ; RFIT-ASY-0104 (GI, 6-pack);
Lot: All unexpired BIOFIRE GI Panel lots when used with Remel Cary-Blair transport medium
S/N: N/A
SW-Version: N/A

IVD: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
FR-1
EN-1

Vk_20240702_12

Sarstedt AG & Co.

S-Monovette, Lithium-Heparin
Model: 04.1936.100
Lot: 4031821

MD: Tubes, Blood Collection

DE-1
FR-1
EN-1

Vk_20240708_14

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.19.x

MD: General Medicine Instruments - Other

DE-1
FR-1
EN-1

Vk_20240705_27

Philips Medical Systems

IntelliVue MX400-550
Model: 866060, 866062, 866064, 866066; N/A
S/N: see FSN
SW-Version: L.x and M.x; K.x provided with L.x entitlements

MD: Multiple vital physiological parameter monitoring system, clinical

DE-1
FR-1
EN-1

Vk_20240702_27

GE Healthcare Finland Oy

Centricity High Acuity Anesthesia

MD: Patient health record information system

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

Vk_20240702_20

(Updated )

COPAN ITALIA SpA

Transystem / Specimen collection device
Model: 900-0370
Lot: 230397900, 230535300, 230627500, 231877400

MD: Sample Collection Swabs With Transport Medium

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

Vk_20240625_02

Schiller Medical

SCHILLER
Model: DEFIGARD Touch7
S/N: All
SW-Version: Soft 8 and lower

MD: Physiologic-monitoring defibrillation system

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

Vk_20240628_29

(Updated )

Boston Scientific Neuromodulation Corporation

Vercise Genus
Model: M365DB12160, M365DB12320
S/N: 100209 - 753347, 100104 - 753200

AIMD: Deep brain electrical stimulation system

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

Vk_20240418_15

(Updated )

Olympus Winter & Ibe GmbH

Electrosurgical Generator - ESG-410
Model: WA91307W
S/N: see FSN

MD: Electrosurgical Units

DE-1
FR-1
EN-1

Vk_20240620_04

ID GmbH & Co. KGaA

ID MEDICS
SW-Version: 7.10.19 (bis HF11), 7.10.46 (bis HF4)

MD: Medical Device Software - Not Included In Other Classes

DE-1

Vk_20240627_21

Boston Scientific Corporation

Capio SLIM Suture Capturing Device
Model: M0068318261, M0068318260, M0068318250
Lot: See FSN

MD: Suturing unit, single-use

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

Vk_20240628_04

nal von minden GmbH

NADAL Troponin I Test
Model: 282041N-10, 282041N-20
Lot: 180941

IVD: Troponin I/T - RT & POC

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

Vk_20240701_17

Gyrus ACMI Inc.

Soltive Laser System
Model: TFL-PLS, TFL-SLS, TFL-AFSWL; EGTFL-PLS, EGTFL-SLS, EGTFL-AFSWL
S/N: All

MD: General/multiple surgical solid-state laser system

DE-1
FR-1
EN-1

Vk_20240625_26

Siemens Healthcare GmbH

LUMINOS Lotus Max
Model: see FSN

Luminos Agile Max
Model: see FSN

Luminos dRF Max
Model: see FSN

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

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

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

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

Vk_20240628_28

Zimmer, Inc.

CPT Hip System Femoral Stem
Model: See FSN
Lot: all lot

MD: Uncoated hip femur prosthesis, one-piece

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

Vk_20240701_25

Medtronic Xomed Inc

NIM Vital Nerve Monitoring System
Model: NIM4CM01, NIM4CPB1
S/N: All
SW-Version: v1.4.3 and earlier

MD: Nervous System Monitoring Systems

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

Vk_20240628_33

(Updated )

Schiller AG

Tempus LS
Model: 3.940590; 1A.702100

MD: Physiologic-monitoring defibrillation system

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

Vk_20240410_30

(Updated )

Limacorporate S.p.a.

DISCOVERY HUMERAL STEM
Model: See FSN
Lot: See FSN

MD: Elbow Prostheses Humeral Components

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

Vk_20240611_02