Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2024 – 31.12.2024 Швейцарія

(Updated )

Physiomed Elektromedizin AG

Compass MTT Rückentrainer Kombi
Model: 10113700
S/N: 10113700.21.0453.00.00 bis 10113700.24.02228.00

MD: Exercisers, Back

DE-1
DE-2
DE-3

Vk_20241202_12

(Updated )

Olympus Medical Systems Corp.

Forceps/Irrigation Plug (Isolated Type)
Model: MAJ-891 / N6149350
Lot: All

MD: Endoscope working-channel valve, reusable

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

Vk_20241218_22

(Updated )

Instrumentation Laboratory Co.

HemosIL Heparin Calibrators
Model: 0020300600
Lot: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673

IVD: Heparin anti-Xa IVD, calibrator

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

Vk_20241227_26

(Updated )

Becton, Dickinson and Company

BD PCR Cartridge
Model: 437519
Lot: see FSN

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory

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

Vk_20241213_27

(Updated )

Roche Diabetes Care GmbH

Accu-Chek Care
Model: 1009594600, device identifier: 04015630088928
SW-Version: 1.0.2, 1.0.4

MD: General Medicine Diagnosis And Monitoring Instruments - Medical Device Software

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

Vk_20241021_02

(Updated )

Nobel Biocare AB

Nobel Biocare N1 TiUltra TCC
Model: see FSN
Lot: see FSN
SW-Version: N/A

MD: Dental Implants

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

Vk_20241219_01

(Updated )

Venclose, Inc.

Venclose EVSRF Catheter
Model: VCOUS6F60, VCOUS6F100
Lot: see FSN

MD: Peripheral vascular electrocautery catheter, single-use

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

Vk_20240926_35

(Updated )

Accuray Incorporated

Cyberknife
Model: All CyberKnife using Standard Treatment Couch

MD: Single Energy Linear Accelerators

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

Vk_20241204_48

(Updated )

Philips Medical Systems Nederland B.V.

Philips Allura Xper
Model: see FSN
SW-Version: R 7.6 - R 8.1

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

DE-1
IT-1
EN-1

Vk_20241113_01

bioMérieux

VIDAS CK-MB
Model: 30421
Lot: 1010844200, 1010959330, 1010987820
S/N: N/A
SW-Version: N/A

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

DE-1
FR-1
EN-1

Vk_20241227_02

Draeger Medical Systems, Inc.

Edifier Lautsprecher
Model: MS34036
Lot: See FSN

Infinity Central Station
Model: MS26800
SW-Version: VG3.0

MD: Centralized patient monitor

MD: Centralized patient monitor

DE-1
FR-1
IT-1

Vk_20241227_35

Mercury Medical

T-Piece Resuscitator
Model: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050841, 1050842
Lot: See FSN
S/N: See FSN

MD: Manually Operated Pulmonary Resuscitators

DE-1

Vk_20241216_02

Löwenstein Medical Innovation GmbH & Co. KG

elisa
Model: elisa 300, elisa 500, elisa 600, elisa 800, elisa 800VIT
SW-Version: 2.13.6

MD: Intensive care ventilator

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

Vk_20241227_42

Philips Electronics Nederland B.V.

Spectral CT/Spectral CT Plus
Model: 728333, 728340, 728344
S/N: 10042, 10065, 10075, 10077, 10120, 10143, 10156, 10247
SW-Version: 5.0.X

MD: EMDN=37618

DE-1
FR-1

Vk_20241118_13

QuidelOrtho (Ortho-Clinical Diagnostics Inc.)

VITROS XT7600
Model: 6844461
S/N: 76000375, 76000852
SW-Version: 3.8.0 and above

IVD: Multiple clinical chemistry analyser IVD, laboratory

DE-1
EN-1

Vk_20241227_01

Medicrea International

UNiD Adaptive Spine Intelligence (ASI)
SW-Version: UNiD HUB version 4.2.0, UNiD Spine Analyzer version 4.1

MD: Orthopaedic/craniofacial implantation planning software

FR-01
IT-01
EN-01

Vk_20241204_22

Ethicon, LLC

ETHILON Nylon Suture
Model: F2416H, 661H
Lot: 103E7C, 103H5A

ETHIBOND EXCEL Polyester Suture
Model: 6664H, EH7491H
Lot: 103G1B, 103D42

MD: Nylon suture, non-bioabsorbable, monofilament

MD: Polyester suture, non-bioabsorbable, multifilament

DE-1
FR-1
IT-1

Vk_20241220_25

Diametros Medical S.r.l.

Lobster Project 2.0 implantable device
Model: see FSN
Lot: see FSN

MD: Lumbar interspinous decompression spacer

FR-01
IT-01
EN-01

Vk_20241223_33

Boston Scientific Corporation

AXIOS Stent and Electrocautery - Enhanced Delivery System
Model: See FSN
Lot: See FSN
S/N: See FSN

MD: Implantable transenteric drainage tube

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

Vk_20241223_01

Mint Medical GmbH

Mint Lesion
SW-Version: 3.9.0, 3.9.1, 3.9.2, 3.9.3, 3.9.4, 3.9.5, 3.10.0 and 3.10.1

MD: Radiology Instruments - Software Accessories

DE-1
FR-1
EN-1

Vk_20241219_20

Maquet Critical Care AB

Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
Model: 6682285 Vaporizer Sevoflurane QuikFil used with Flow-i: C20 6677200, 688852, C30 6677300, 6888530, C40 6677400, 6888540, Flow-c: 6887700, Flow-e: 6887900
S/N: See FSN

MD: Anaesthesia workstation, general-purpose

EN-1

Vk_20241213_28

(Updated )

Edwards Lifesciences LLC

EZ Glide Aortic Cannula
Model: see FSN
Lot: see FSN
S/N: N/A

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

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

Vk_20241121_15

Spiegelberg GmbH & Co. KG

Probe 3
Model: SND13.1.13
S/N: 32034

lAP Catheter
Model: SND32.1.11
S/N: 2506, 2711

Silverline Ventricular Probe with Cranial Bolt
Model: SND13.1.14S
S/N: 13464

Probe 3PN
Model: SND13.1.53
S/N: 81862

Probe 3XL
Model: SND13.1.13XL
S/N: 66056, 66067, 66073, 66074, 66105, 66116, 79228, 79385, 94283, 94284, 94532, 94533, 101721, 103128, 103234, 104413, 106166

Probe 3PN with Trocar
Model: SND13.1.54
S/N: 18151

MD: Intracerebral infusion/drainage catheter, short-term

MD: Catheter-tip transducer, pressure

MD: Intracerebral infusion/drainage catheter, short-term

MD: Patient monitoring system module, intracranial pressure

MD: Intracerebral infusion/drainage catheter, short-term

MD: Patient monitoring system module, intracranial pressure

DE-1
FR-1
EN-1

Vk_20241212_27

(Updated )

Dedienne Santé

SYMBOL STEM
Model: 3700502202748; 3700502202731
Lot: 360460250A; 356880250A

MD: Press-fit femoral stem prosthesis

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

Vk_20241210_01

(Updated )

Olympus Medical Systems Corp.

Thunderbeat Type - S
Model: TB-0535FCS, TB-0545FCS, TB-0520FCS
Lot: See FSN

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

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

Vk_20241217_30

Datex-Ohmeda Inc.

Tec 6 Plus Vaporizer
Model: see FSN
S/N: see FSN

Tec 820 ISO Vaporizer
Model: see FSN
S/N: see FSN

Tec 820 SEV Vaporizer
Model: see FSN
S/N: see FSN

Tec 850 ISO Vaporizer
Model: see FSN
S/N: see FSN

Tec 850 SEV Vaporizer
Model: see FSN
S/N: see FSN

MD: Desflurane anaesthesia vaporizer

MD: Isoflurane anaesthesia vaporizer

MD: Sevoflurane anaesthesia vaporizer

MD: Isoflurane anaesthesia vaporizer

MD: Sevoflurane anaesthesia vaporizer

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

Vk_20241220_02

Maquet Cardiovascular, LLC

Acrobat Product Family
Model: OM-10000Z, OM-9000Z, OM-5000Z
Lot: Refer to FSN Attachment

MD: Beating Heart Cardiosurgery Devices - Other

DE-1
FR-1

Vk_20241213_01

(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 )

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

Vk_20231227_18

KLS Martin Group

OP-Leuchtensystem (marLED E, marLED X)
Model: 89-800-00-00 / 89-903-00-00 / 89-000-00-00

MD: Medical monitor/light mount

DE-1
EN-1

Vk_20241210_30

(Updated )

PhysIOL s.a.

ISOPURE 123
Lot: See FSN

MICROPURE 123
Lot: See FSN

MD: Iols, Aphakic, Monofocal, Aspheric, Hydrophobic Acrylic

MD: Iols, Aphakic, Monofocal, Aspheric, Hydrophobic Acrylic

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

Vk_20241217_01

Olympus Medical Systems Corp.

Single Use Mechanical Lithotriptor V
Model: BML-V442QR-30; N2303230
Lot: 33K, 34K, 35K, 36K, 37K, 38K, 39K, 3XK, 3YK, 3ZK, 41K, 42K, 43K, 44K

MD: Manual biliary stone fragmenter

DE-1
FR-1
EN-1

Vk_20241217_29

Bonree Medical Co., Ltd.

Disposable Electronic Ureteroscope
Model: SEPUR3006E
Lot: 24020301H

MD: Ureterorenoscopes

DE-1
FR-1
EN-1

Vk_20241120_10

Imaxeon Pty Ltd Rydalmere Metro Centre

Medrad Centargo CT Injection System
Model: CENT-SYS-BAT, CENT-SYS-OCS

MD: CT contrast medium injection system, line-powered, mobile

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

Vk_20241219_05

Coloplast A/S

Product families from the interventional urology portfolio
Model: see details in FSN in Appendix 1 version 3.0
Lot: see details in FSN in Appendix 1 version 3.0
SW-Version: Not applicable

MD: Product families from the interventional urology portfolio, see details in FSN in Appendix 1 version 3.0

DE-1
FR-1
IT-1

Vk_20241206_28

(Updated )

Richard Wolf GmbH

SWISS PIEZOCLAST
Model: 80414
S/N: See FSN

MD: Electromechanical orthopaedic extracorporeal shock wave therapy system

DE-1
FR-1
EN-1

Vk_20241209_21

R-Biopharm AG

RIDA QUICK Rota/Adeno/Noro Combi
Model: N1903
Lot: BH34-BI31.28

IVD: Viral Antigen/antibody Detection - Other

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

Vk_20241219_02

(Updated )

Roche Diagnostics GmbH

IRON 2
Model: 03183696122
Lot: All

IVD: Iron IVD, kit, spectrophotometry

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

Vk_20210413_16

GE Medical Systems Israel Functional Imaging

Multiple GEHC Nuclear Medicine systems
Model: see FSN
S/N: see FSN

MD: Stationary gamma camera system

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

Vk_20241218_28

iThera Medical GmbH

MSOT Acuity Echo CE
Model: SYS-MSOTACUITYechoCE2
S/N: 2-21-04

MD: Various Radiodiagnostic And Interventional Instruments ¿ Other

DE-1
EN-1

Vk_20241218_24

Canon Medical Systems Corporation

Vantage Orian, Vantage Elan, Vantage Titan
Model: MRT-1550, MRT-2020, MRT-1504
S/N: S2E20Y2505

MD: Full-body MRI system, superconducting magnet

DE-1

Vk_20241217_13

(Updated )

Kirwan Surgical Products LLC

Disposable Bipolar Pencil 25GA Straight
Model: 14-5011, 14-5011L
Lot: see FSN

MD: Universal foot-controlled electrosurgical diathermy system conducting unit, single-use

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

Vk_20241119_29

GE OEC Medical Systems, Inc.

OEC Elite
S/N: see FSN

OEC 3D
S/N: see FSN

OEC 9900
S/N: see FSN

OEC 9800
S/N: see FSN

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

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

MD: Stationary basic diagnostic x-ray system, digital

MD: Stationary angiographic x-ray system, analogue

DE-1
FR-1
IT-1

Vk_20241212_12

Sedana Medical Limited

Sedaconda Syringe
Model: 1026022
Lot: Potentially F000044, F000055, F000068, F000069, F000072, F000081

MD: Respiratory And Anaesthesia Devices - Other

DE-1
FR-1
IT-1

Vk_20241202_11

Sarstedt AG & Co.

Blutkultur-Adapter L
Model: 14.1207
Lot: 4074421

Blutkultur-Adapter U
Model: 14.1209
Lot: 4074321, 4074322, 4074521

IVD: Fittings/Adapters

IVD: Fittings/Adapters

DE-1
FR-1
IT-1

Vk_20241216_01

SPINEART SA

CERVICAL DISC PROSTHESIS BAGUERA C
Model: CDP-TI 13 05-S, CDP-TI 13 06-S
Lot: 8-4394, 8-4395

MD: Cervical total intervertebral disc prosthesis, modular

DE-1
FR-1
EN-1

Vk_20241210_39

Cardiac Pacemaker Inc

Subpopulation of ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Model: see FSN
Lot: see FSN

MD: Pacemaker, implantable, biventricular (Cardiac Re-synchronization Therapy pacemakers); Pacemaker, implant, dual-chamber, rate responsive; Pacemaker, implant, single-chamber, rate-responsive

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

Vk_20241213_03

Philips Electronics Nederland B.V.

Philips Azurion system

Allura Xper

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

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

DE-1
FR-1
IT-1

Vk_20241212_20

(Updated )

Rehaforum Medical GmbH

Wannenbrett mit Griff
Model: 09233208 and 01840222
Lot: see FSN

MD: Chair/hop bath

DE-1
FR-1
IT-1

Vk_20241204_17

GE Healthcare Japan Corporation

Revolution Ascend
Model: See FSN
Lot: See FSN

MD: Full-body CT system

DE-1
FR-1

Vk_20241212_14

(Updated )

Arthrex INC

Synergy RF Console
Model: AR-9800

MD: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

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

Vk_20241202_03

Max Mobility LLC

SpeedControl Dial used with the Smartdrive MX2+
Model: MX2-3DC

MD: Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

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

Vk_20241212_04

Medtronic Inc.

DLP One-Piece Pediatric Arterial Cannula 8 Fr
Model: 77008
Lot: 2024010723, 202404C049

DLP One-Piece Pediatric Arterial Cannula 14 Fr
Model: 77014
Lot: 2023121097

EOPA Elongated One Piece Arterial Cannula 18 Fr
Model: 77418
Lot: 2022041038

EOPA Elongated One Piece Arterial Cannula 22 Fr
Model: 77422
Lot: 2023020934

Select Series Angled Tip Arterial Cannula 22 Fr
Model: 72422
Lot: 2023071075, 202309C075

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

DE-01
FR-01
EN-01

Vk_20241212_13

Canon Medical Systems Corporation (ehemals Toshiba Medical Systems Corporation)

X-Ray Interventional Systems
Model: INFX-8000C, INFX-8000F, INFX-8000V, INFX-8000H
S/N: 99D1912053, B2A20X2048, A1C16Z2325, A1B16Z2145, A1C1752364, A1B1752157, 99D1952063, F1A2252011, 99D2182129, B2A2182118, 99D1822035

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20241204_49

ElitechGroup S.p.A.

ELITe InGenius Consumable Set
Lot: 114 453, 115 535, 117 336, 118 087

IVD: Nucleic Acid Testing Instruments Except Micro-arrays - Consumables

DE-1
IT-1
EN-1

Vk_20241204_15

Safersonic Medizinprodukte Handelsges.m.b.H.

Safersonic Regular Sterile Transducer Cover
Model: SAF.612.18120.CH; SAF.612.18120.CH
Lot: 3181130439

MD: Wrappers, Sterile

DE-1
FR-1

Vk_20241212_16

Medis Medical Imaging Systems bv

QAngio XA 3D
Model: QAngio XA 3D
S/N: 2.2.10.2
SW-Version: 2.2.10.2

MD: Laboratory instrument/analyser application software IVD

DE-01
FR-01
EN-01

Vk_20241126_12

DH Healthcare GmbH

DeepUnity Viewer 2.x

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20241209_28

Medicon eG

Gubisch Osteotom
Model: 67.30.53; 67.30.52
Lot: see FSN

MD: Plastic surgery osteotome

DE-1
FR-1
IT-1

Vk_20241202_10

DH Healthcare GmbH

DeepUnity Viewer 2.x

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20241209_25

CompuGroup Medical Software GmbH

CGM CLINICAL Medication
SW-Version: 8.x, 9.x, 10.x

MD: Medical Device Software - Not Included In Other Classes

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

Vk_20241204_43

(Updated )

Roche Diabetes Care GmbH

Accu-Chek Spirit 3.15 ml Plastic Cartridge
Model: 04949935001 / 05206073001
Lot: see FSN

MD: Portable Microinfusion Instruments - Consumables

DE-1-DIST
DE-1-HCP
DE-1-PAT1
FR-1-DIST
FR-1-HCP
FR-1-PAT1
IT-1-DIST
IT-1-HCP
IT-1-PAT1
EN-1-DIST
EN-1-HCP
EN-1-PAT1

Vk_20241127_02

(Updated )

Immunotech S.A.S.

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

IVD: Cardiac Markers

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

Vk_20241127_03

Medtronic Navigation Inc.

Sterile Percutaneous Reference Pin
Model: 9733235, 9733236
Lot: See FSN

MD: Orthopaedic stereotactic surgery system

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

Vk_20241204_42

(Updated )

Baxter Healthcare SA

MINICAP EXTEND LIFE PD TRANSFER SET
Model: R5C4482, R5C4484
Lot: See FSN

MD: Peritoneal dialysis system tubing set

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

Vk_20241025_13

3M Unitek Corporation

3M Transbond Self-Etching Primer
Model: 712-090, 712-091
Lot: 11093917, 11106533, 11120254, 11153742, 11155372, 11173412, 11165780, 11165793

MD: Dentine bonding agent/set

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

Vk_20241210_03

Biocartis NV

Idylla Instrument
Model: see FSN
S/N: see FSN

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

DE-1
FR-1
EN-1

Vk_20241210_02

(Updated )

Tem Innovations GmbH

ROTEM sigma complete
Model: 555501 / 555502
Lot: S221203 and higher / S221204 and higher
S/N: N/A
SW-Version: N/A

IVD: Other Other Haemostasis Reagents

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

Vk_20241126_10

(Updated )

DIABELOOP SA

YourLoops
S/N: All associated devices available on the market
SW-Version: 3.4.0

MD: Wireless patient monitor/sensor reporting software, layperson-use

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

Vk_20241108_02

(Updated )

Baxter Healthcare SA

MINICAP EXTEND LIFE PD TRANSFER SET
Model: R5C4482, R5C4484
Lot: All lots within expiry

MD: Peritoneal dialysis system tubing set

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

Vk_20241024_01

COLLIN

Pointe de stylet pour otologie
Model: PGPOINTER
Lot: 111590

MD: Surgical Navigation Instruments - Consumables

DE-1
FR-1
IT-1

Vk_20241122_05

Greiner Bio-One GmbH

HOLDEX Single-Use Holder PP single-packed, steril
Model: 450263
Lot: A240745B, A24083GD

IVD: Luer-ended blood collection tube spike

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

Vk_20241108_01

(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 )

Weinmann Emergency Medical Technology GmbH + Co. KG

MEDUMAT Standard 2 with CO2 measurement
Model: WM 29500
Lot: manufactured 2013

MEDUMAT Transport with CO2 measurement
Model: WM 28415, WM 28400, WM 28615
Lot: manufactured 2008

MEDUMAT Standard with CO2 measurement
Model: 28710-02, 28710-04, 28950, 28944, 29500
Lot: manufactured 2013

MEDUMAT Transport with CO2 measurement
Model: 28415, 28400, 28615
Lot: manufactured 2008

MD: Transport electric ventilator

MD: Transport electric ventilator

MD: Transport electric ventilator

MD: Transport electric ventilator

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

Vk_20241115_13

(Updated )

Baxter Medical Systems GmbH + Co. KG

TruSystem 7000
Model: 1841046, 1841048, 1841049, 1841082, 2065385
S/N: All

MD: Universal operating table, electromechanical

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

Vk_20240930_17

(Updated )

Becton, Dickinson and Company

BD Phoenix M50 Automated Microbiology System Instrument
Model: 443624
S/N: All serial numbers

BD BACTEC Blood Culture System
Model: 441385, 445475, 442296, 445570, 445570U
S/N: All serial numbers

BD MAX System
Model: 441916
S/N: All serial numbers

BD COR System
Model: 443988, 443989, 443990
S/N: All serial numbers

BD EpiCenter Microbiology Data Management System
Model: 441007, 440887, 440981
S/N: All serial numbers

BD Synapsis Informatics Solution
Model: 444150
S/N: All serial numbers

IVD: Microorganism identification/antimicrobial-susceptibility analyser IVD

IVD: Blood culture analyser IVD

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory

: Non-IVD

: Non-IVD

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

Vk_20241101_02

(Updated )

Hermes Medical Solutions AB

Hybrid Recon
SW-Version: 5.0, 4.0

MD: Various Instruments For Nuclear Medicine - Medical Device Software

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

Vk_20241104_19

Sofradim Production

ProGrip Self gripping Polyester Mesh
Model: TEM1509G, TEM1515G
Lot: TEM1509G, lot #SYF0106X; TEM1515G, lot #SYF0272X

MD: Surgical Meshes, More Than One Component

DE-1
FR-1

Vk_20241128_16

Epocal Inc.

epoc NXS Host
Model: SMN 11413475 (US), SMN 11413497 (EU), SMN 11413498 (JP), SMN 11413506 (CA), SMN 11413517 (MX), SMN 11413518 (ROW), SMN 11413583 (CN, KR), SMN 11413879 (IN)
Lot: N/A
S/N: all
SW-Version: 4.14.9

IVD: Metabolic profile clinical chemistry analyser IVD

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

Vk_20241126_22

(Updated )

Becton, Dickinson and Company, BD Biosciences

BD FACSLyric Flow Cytometer
Model: Refer to FSN
S/N: Refer to FSN

IVD: Flow cytometry analyser IVD

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

Vk_20241121_16

Breas Medical AB

Vivo 45LS
Model: 230072, 230472
Lot: Date of manufacture on or before 230831 (31 August 2023)
SW-Version: 3.1.9 or earlier

MD: Pulmonary Ventilators For Non¿hospital Use

DE-1
FR-1
IT-1

Vk_20241119_03

(Updated )

Arthrex INC

OATS 2.0 Single-Use Set, 12 mm
Model: ABS-8981-12S
Lot: see FSN

MD: Orthopaedic osteotome

DE-1
FR-1
EN-1

Vk_20241111_01

Kinova inc

Kinova Jaco assistive robotic arm
Model: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2

MD: Wheelchairs Accessories - Other

DE-1

Vk_20241129_08

(Updated )

Oxoid Deutschland GmbH, Thermo Fisher Scientific

Thermo Scientific Yersinia Selective Agar
Model: PO5044A
Lot: 6190052

IVD: GMDN=5032384129140

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

Vk_20241120_22

(Updated )

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: All

MD: General Medicine Instruments - Other

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

Vk_20241011_42

The Spectranetics Corporation

Turbo Elite Laser Atherectomy Catheter
Model: 414-151, 417-152, 420-006, 423-001, 423-135-01, 423-135-02, 425-011, 425-135-01, 425-135-02
Lot: all lots
SW-Version: Not applicable

MD: Atherectomy laser system beam guide-catheter, peripheral

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

Vk_20241126_13

Medtronic Inc.

SynchroMed Clinician Programmer Application
Model: A810
S/N: all
SW-Version: 2.x

MD: Implantable Pumps Programmers - Medical Device Software

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

Vk_20241121_14

Cartiva, Inc.

Cartiva Synthetic Cartilage Implant
Model: CAR-06, CAR-06-AUS, CAR-06-BRZ, CAR-06-US, CAR-08, CAR-08-AUS, CAR-08-BRZ, CAR-08-US, CAR-10, CAR-10-AUS, CAR-10-BRZ, CAR-10-US, CAR-12, CAR-12-AUS, CAR-12-BRZ, CAR-12-US, WDG-10, WDG-15
Lot: All

MD: Total metatarsophalangeal joint prosthesis, one-piece

DE-1
FR-1

Vk_20241115_22

Beckman Coulter , Inc.

Access Intact PTH Reagent
Model: A16972
Lot: see FSN

IVD: Parathyroid Hormone Intact

DE-1
FR-1
EN-1

Vk_20241120_07

Abbott Medical

MERLIN PATIENT CARE SYSTEM (PCS)
Model: 3650
S/N: 3650: Software model 3330 28.0.X - 28.1.X Rev 1

AIMD: Cardiac pulse generator software

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

Vk_20241121_10

DiaSorin Inc

LIAISON QSET Device Plus
Model: 319060
Lot: 225084, 233154, 223244, 230094, 259144, 224244, 219104, 228174, 251234, 232094, 236174, 252244, 224124, 210204, 223274, 217134 , 221214, 221294, 234114, 228224, 232294, 205144, 229224, 222314

IVD: Samples Analyses, Plastic Tubes With Additives

DE-1
FR-1

Vk_20241111_17

mbits imaging GmbH

mRay
Model: mRay 6.9
SW-Version: 6.9

MD: Radiology Instruments - Software Accessories

DE-01

Vk_20241114_16

Fresenius Kabi AG

Aurora Plasmapheresis System
Model: 6R4601, 4R4601, 4R4601R
S/N: All

MD: Apheresis system

DE-1

Vk_20241114_12

(Updated )

M.A. Med Alliance SA (MedAlliance)

Selution SLR PTCA Balloon Catheter
Model: SE18-030100
Lot: L92505, L92835, L93029, L93495

MD: Coronary angioplasty balloon catheter, drug-coated

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

Vk_20241030_04

(Updated )

machineMD AG

neos
Model: NEOS-01-CH
Lot: See FSN
S/N: See FSN

MD: Ophtalmology Assessments And Diagnosis Instruments

DE-1
FR-1
EN-1

Vk_20241022_18

ICU Medical, Inc.

Plum 360 infusion systems
Model: See FSN
Lot: See FSN

MD: Bedside infusion pump, single-channel

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

Vk_20241118_08

Vascutek Ltd

Thoraflex Hybrid
Model: N/A; N/A
Lot: N/A
S/N: N/A
SW-Version: N/A

MD: Descending thoracic aorta endovascular stent-graft

DE-1
FR-1
IT-1

Vk_20241113_03

CompuGroup Medical Software GmbH

CGM CLINICAL Medication
SW-Version: 9.1, 9.4, 10.2, 11.1

MD: Medical Device Software - Not Included In Other Classes

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

Vk_20241115_12

Medicon eG

Mercedes Liposuct Kan 15cm
Model: 09.88.30
Lot: RSIC3-0023 / RAIS3-0023 / FIIS4-0023

MD: Suction And Irrigation Surgical Cannulas And Handpieces, Reusable

DE-1
FR-1
EN-1

Vk_20241111_10

GS Elektromedizinische Geräte G. Stemple GmbH

Battery corpuls aed
Model: 06120
Lot: all
S/N: all

MD: DEFIBRILLATORS - HARDWARE

DE-1
EN-1

Vk_20241112_18

(Updated )

Philips Medical Systems Nederland B.V.

Philips MR systems with g-MDU
Model: See FSN

MD: Full-body MRI system, superconducting magnet

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

Vk_20240426_19

(Updated )

Philips Healthcare Enterprise Imaging Informatics

Achieva TX Interventional Coil 3.0T, dS Breast 16c
Model: see FSN

MD: Full-body MRI system, superconducting magnet

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

Vk_20241105_31

QuidelOrtho (Ortho-Clinical Diagnostics Inc.)

VITROS Chemistry Products CRP Slides
Model: 1926740
Lot: 1221 (expired 01-Oct-2024) and 1222 (expires 01-Jan-2025)

IVD: C-reactive protein (CRP) IVD, reagent

DE-1

Vk_20241028_13

(Updated )

Welch Allyn, Inc.

ProBP 3400 Blood Pressure Device
Model: 34XFST-2; PWCD-5WT-2; PWCD-6WT-2
Lot: see FSN

SPOT VISION SCREENER
Model: VS100S-2; 106364
Lot: see FSN

MD: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

MD: Vision/eye movement analysis system

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

Vk_20240424_01

(Updated )

Becton, Dickinson and Company

BD BBL Sensi Disc Ampicillin 2 µg (AM-2)
Model: 231263
Lot: see FSN

IVD: Antibacterial susceptibility testing disc IVD

DE-1
FR-1
EN-1

Vk_20241105_01

(Updated )

Fresenius Medical Care AG & Co. KGaA

multiFiltratePRO
Model: M205001
SW-Version: Software versions 6.02 and 5.02

MD: Haemodialysis system, institutional/home-use

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

Vk_20240516_04

Siemens Healthcare Diagnostics Inc.

Atellica CI Analyzer
Model: 10947347
SW-Version: 1.28.51

IVD: Multiple clinical chemistry analyser IVD, laboratory

DE-1
FR-1
EN-1

Vk_20241106_01

Boston Scientific Corporation

Acurate neo2 and Prime Aortic Valve System
Model: See FSN
Lot: See FSN

MD: Aortic transcatheter heart valve bioprosthesis, stent-like framework

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

Vk_20241104_17

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.17.01.00

MD: General Medicine Instruments - Other

DE-1
FR-1
EN-1

Vk_20241011_43

Medtronic Inc.

Becker and Exacta External Drainage and Monitoring Systems
Model: 24146, 25120, 26040, 27581, 27609, 27636, 27666, 27670, 27672, 27702, 27732, 27779, 27785, 27795, 27811, 46129, 46700, 46705
Lot: All

MD: Cerebrospinal fluid external drainage kit

DE-1
FR-1
EN-1

Vk_20241104_14

(Updated )

KayserBetten GmbH & Co. KG

KayserBett OLAF
Model: OLAF 98 & OLAF 135
S/N: see FSN

MD: Electrical assistive bed

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

Vk_20241024_39

(Updated )

KayserBetten GmbH & Co. KG

KayserBett OLAF
Model: OLAF 98 & OLAF 135
S/N: SN 017071, SN 018594, SN 019400, SN 019503, SN 019716

MD: Electrical assistive bed

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

Vk_20241024_32

(Updated )

KayserBetten GmbH & Co. KG

KayserBett EMMA
Model: EMMA1, EMMA2
S/N: see FSN

KayserBett IDA
Model: IDA
S/N: see FSN

MD: Electrical assistive bed

MD: Electrical assistive bed

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

Vk_20241029_24

(Updated )

Philips Medical Systems Nederland B.V.

Vue PACS
Model: 1149418
SW-Version: v12

MD: Radiological PACS software

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

Vk_20241015_28

(Updated )

Beckman Coulter , Inc.

Access Substrate
Model: 81906
Lot: see FSN

IVD: Substrates

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

Vk_20240228_03

Biomet Sports Medical llc

JuggerLoc Drill Guide
Model: 110027357
Lot: See FSN

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

DE-1

Vk_20241101_22

Siemens Healthcare Diagnostics Inc.

Atellica CH ß2-Microglobulin
Model: 11097635

IVD: Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

DE-1
FR-1
IT-1

Vk_20241101_03

(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 )

Karl Storz SE und Co. KG

Aggressive Cutter, Full Radius Resector & Aggr. Pro Line Shaver Blade; sterile
Model: 28208BKS, 28206CBS, 28205NDS
Lot: see FSN

Aggressive Barrel Burr
Model: 28205HES, 28205HDS
Lot: see FSN

Round Burr, Finish Barrel Burr & Semi Hooded Barrel Burr; sterile
Model: 28205FDS, 28205GDS, 28208IDS
Lot: see FSN

MD: Arthroscopic shaver system blade, single-use

MD: Orthopaedic bur, single-use

MD: Orthopaedic bur, single-use

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

Vk_20241018_18

(Updated )

Philips Medical Systems Nederland B.V.

Zenition 50
Model: 718096

Zenition 70
Model: 718133

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

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

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

Vk_20240930_20

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

Vk_20231127_06

D.O.R.C. Dutch Ophthalmic Research Center

Silicone Oil Syringe
Model: SIL-1000-S, SIL-2000-S, SIL-5000-S

MD: Vitreous humour replacement medium, postoperative

EN-1

Vk_20241016_25

ICU Medical

Tracheal Tube Introducer
Model: 14-504-17
Lot: see FSN

Tracheal Tube Guide
Model: 14-504-68, 14-504-76
Lot: see FSN

MD: Endotracheal tube introducer, reusable

MD: Endotracheal tube guide, reusable

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

Vk_20241030_17

Bard Access Systems Inc

PowerPICC
Model: see FSN
Lot: see FSN

MD: Peripherally-inserted central venous catheter

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

Vk_20241029_02

Advanced Medical Solutions Limited

Biatain Alginate
Model: see FSN
Lot: see FSN

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

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

Vk_20241024_31

(Updated )

SLE Ltd

Reusable and Single Use Flow Sensors
Model: N5402-REV2, N5302/05, N5302/50, L6000/SU, L6000/SU/DHW, NA5000/RU/01, NA5000/RU/02, NA5000/SU/01
S/N: see FSN

MD: Breathing circuit gas-flow sensor, single-use/reusable

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

Vk_20241010_18

(Updated )

Welch Allyn, Inc.

Welch Allyn Diagnostic Cardiology Suite
SW-Version: V2.1.0

Connex Cardio
SW-Version: V1.0.0 - V1.1.1

Rscribe
SW-Version: V6.0.0 - V6.2.3

Hscribe
SW-Version: V4.0.0 - V4.34, V6.1.0 - V6.4.1

Q-Stress
SW-Version: V6.0.0 - V6.3.2

Vision Express
SW-Version: V6.1.0 - V6.4.1

Xscribe
SW-Version: V6.0.0 - V6.3.2

MD: Electrocardiograph, professional, multichannel

MD: Diagnostic spirometer, professional

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiographic long-term ambulatory recording analyser application software

MD: Cardiopulmonary stress exercise monitoring system computer

MD: Electrocardiographic long-term ambulatory recording analyser application software

MD: Cardiopulmonary stress exercise monitoring system computer

DE-1
FR-1
IT-1

Vk_20241023_17

(Updated )

Gambro Lundia AB

AK 98
Model: 115244, 115248, 115249, 115250, 955106, 955403, 955404, 955406, 955989
S/N: All serials with runtime less than 500 hours

MD: Haemodialysis system, institutional/home-use

DE-1
FR-1
IT-1

Vk_20241029_01

(Updated )

Baxter Medical Systems GmbH + Co. KG

iLED 7
Model: 4068110, 4068120, 4068140, 4068210, 4068310, 4068410
Lot: All
S/N: All

MD: Operating room light

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

Vk_20240620_26

Cook Endoscopy

Hemospray Endoscopic Hemostat
Model: HEMO-7, HEMO-10, HEMO-7-EU
Lot: See FSN

MD: Non-organic haemostatic agent

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

Vk_20241024_06

(Updated )

Gyrus ACMI, Inc.

UroPass Ureteral Access Sheath Set
Model: See FSN
Lot: All

MD: Dilator, Catheter

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

Vk_20241001_27

(Updated )

Terumo BCT, Inc.

COBE 2991 Cell Processor System
Model: 90819 and 90901
Lot: see FSN
SW-Version: N/A

MD: Blood transfer set

DE-1
FR-1

Vk_20241018_28

Fresenius Kabi AG

Lovo Disposable Kits
Model: X6R4909A
Lot: FA23K16049, FA24A09217

MD: Blood Transfer Bag

DE-1

Vk_20241028_11

MAQUET Cardiopulmonary GmbH

Universal Remote Control
Model: 100925A0
S/N: All serial numbers

MD: Medical device remote control keypad

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

Vk_20241028_02

(Updated )

OSCOR Inc.

Axillary Insertion lntroducers and Introducer Kits
Model: AB-81-006Z-B
Lot: 1554119, 1588790, 1602807, 1605010, 1621646, 1638352, 1652405, 1668195, 1672375, 1680301, 1686703, 1702341, 1706967, 1713870, 1717202, 1729155, 1745030

MD: Vascular catheter introduction set, nonimplantable

DE-1
FR-1
EN-1

Vk_20240924_27

Boston Scientific Corporation

AMS 800 Artificial Urinary Sphincter
Model: See FSN
Lot: See FSN
S/N: See FSN

MD: Urethral sphincter prosthesis, non-powered

DE-1
EN-1

Vk_20241028_39

(Updated )

Radiometer Medical

safePICO A
Model: 957-204
Lot: All

IVD: Blood gas syringe IVD, sodium heparin

DE-1
FR-1
EN-1

Vk_20241015_23

Hyaltech Ltd

Z-Hyalin
Model: 003500-0026-896 & 003500-0055-885
Lot: 10351CA, 10370BC, 10370AA, 10362BA, 10351CC, 10370BD

MD: Vitreous/aqueous humour replacement medium, intraoperative

DE-1
EN-1

Vk_20241022_20

(Updated )

Siemens Healthcare Diagnostics Inc.

Atellica CH Reaction Cuvette Segment
Model: SMN 11099326
Lot: See FSN

IVD: Laboratory analyser cuvette IVD, reusable

DE-1-wSRS
DE-1-woSRS
FR-1-wSRS
FR-1-woSRS
IT-1-wSRS
EN-1-wSRS
EN-1-woSRS

Vk_20241025_01

(Updated )

Olympus Medical Systems Corp.

Single Use Biopsy Valve
Model: MAJ-1555 Single Use Biopsy Valve; N3043000
Lot: 1YH, 1ZH, 21H, 22H, 23H.

MD: Endoscope working-channel valve, single-use

DE-1
FR-1
EN-1

Vk_20241008_19

Meridian Medical d.o.o.

MR Q SLT
Model: s
S/N: 1400-015, 1400-087
SW-Version: QS.01.01.04

MD: Neodymium Surgical Laser

EN-1

Vk_20240906_22

(Updated )

Panthera AB

Side Guard
Model: 4422033, 4422034, 4423033, 4423034

MD: Push-rim manual wheelchair, non-bariatric

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

Vk_20241007_32

(Updated )

Olympus Winter & Ibe GmbH

Outer sheath, 22.5 Fr.
Model: WA22810A
S/N: All

MD: Cystoscopes, Rigid

DE-1
EN-1

Vk_20241009_15

(Updated )

DiaMed GmbH

LISS/Coombs
Model: see FSN
Lot: all lots currently in use and future lots until further notice

Coombs Anti-IgG
Model: see FSN
Lot: all lots currently in use and future lots until further notice

ID-Diacell I-II-III
Model: see FSN
Lot: all lots currently in use and future lots until further notice

ID-DiaCell I-II-III Asia
Model: see FSN
Lot: all lots currently in use and future lots until further notice

ID DiaScreen ID number 50571
Model: see FSN
Lot: all lots currently in use and future lots until further notice

IVD: Polyspecific antihuman globulin/complement IVD, antibody

IVD: Polyspecific antihuman globulin/complement IVD, antibody

IVD: Antibody screening reagent red blood cell IVD, kit, agglutination

IVD: Antibody screening reagent red blood cell IVD, kit, agglutination

IVD: Polyspecific antihuman serum

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

Vk_20240310_15

(Updated )

Radiometer Medical

TCM5
Model: 393-500
SW-Version: 1.5.0, 1.5.0.1

MD: Transcutaneous blood gas monitoring system

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

Vk_20241017_24

Drägerwerk AG & Co. KGaA

Atlan
Model: 8621100, 8621300, 8621400, 8621500, 8621600
S/N: see FSN

MD: Anesthesia Units

DE-1
FR-1
IT-1

Vk_20241011_47

LivaNova Deutschland GmbH

Essenz Perfusion System
Model: 49-00-10
S/N: 49PK00205, 49PK00244, 49PK00246, 49PK00279, 49PK00206, 49PK00204, 49PK00454, 49PK00489
SW-Version: 1.5

MD: Heart-Lung Bypass Units

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

Vk_20241021_07

EFB Elektronik GmbH

Netzwerk-Isolator Cat.6A Buchse
Model: NET-ISOADAPRJ45

Netzwerk-Isolator Cat.6A Stecker
Model: NET-ISOKABELRJ45

MD: Network Isolator

MD: Network Isolator

DE-1

Vk_20241014_20

Medtronic MiniMed

MiniMed 640G Insulin Pump
Model: MMT-1711, MMT-1712, MMT-1751, MMT-1752
S/N: all

MiniMed 670G Insulin Pump
Model: MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782
S/N: all

MiniMed 720G Insulin Pump
Model: MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867
S/N: all

MiniMed 740G Insulin Pump
Model: MMT-1811, MMT-1812, MMT-1861, MMT-1862
S/N: all

MiniMed 770G Insulin Pump
Model: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892
S/N: all

MiniMed 780G Insulin Pump
Model: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896
S/N: all

MiniMed 630G Insulin Pump
Model: MMT-1714, MMT-1715, MMT-1754, MMT-1755
S/N: all

MiniMed 620G Insulin Pump
Model: MMT-1710, MMT-1750
S/N: all

MiniMed 700G Insulin Pump
Model: MMT-1801, MMT-1805, MMT-1850, MMT-1851
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

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

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

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

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

Vk_20241015_27

(Updated )

Fisher & Paykel Healthcare Ltd

Airvo 3
Model: PT301EW
S/N: 22092HN20 22092HN3V 23115HK2D 23023629P 23115HC5H 22093BR6T 23032H47B 22082959K 22082989M 24012WT5H 22082939H 22082969F
SW-Version: 1.2.0 - 1.5.1

MD: Professional high-flow respiratory unit, humidifying, manual

DE-1-HCP
FR-1-HCP
IT-1-HCP
EN-1-DIST
EN-1-HCP

Vk_20240828_26

ID GmbH & Co. KGaA

ID MEDICS
SW-Version: 7.10.46 / 7.11.22

MD: Medical Device Software - Not Included In Other Classes

DE-1

Vk_20241021_26

Olympus Medical Systems Corp.

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

MD: Flexible video gastroduodenoscope

DE-1
FR-1
EN-1

Vk_20241017_02

nal von minden GmbH

nal von minden Drug- Screen COC 300 Test
Model: 620045
Lot: 182315

IVD: Cocaine + Cocaine Metabolites - RT & POC

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

Vk_20241011_02

INOSYSTEMS

SoKINOX / ServiNO / Monnal iNO
Model: IN000100; IN000101; IN000103; IN000104; IN000105; IN000106; IN000108; IN000109; IN000111; IN000112; IN000120; IN000121; IN000122; IN000123; IN000254; IN000260; IN000261; IN000262; IN000263; IN000264; IN000265; IN000266; IN000267; IN000272
S/N: all

MD: Nitric oxide delivery unit, system-based

DE-1 - Service
DE-1 - User
FR-1 - Service
FR-1 - User
EN-1 - Service
EN-1 - User

Vk_20241015_26

(Updated )

Merivaara Corporation

Merivaara Q-Flow surgical lights
Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, , Q-FLOW MOBILE
Lot: manufactured before 2023
S/N: All devices between 2017 (start of manufacturing) - June 2023

MD: Operating room light system

DE-1

Vk_20241011_17

(Updated )

Boston Scientific Corporation

PolarX
Model: M004CRBS2000, M004CRBS2100
Lot: all

POLARxFit
Model: M004CRBS2010, M004CRBS2060, M004CRBS2110, M004CRBS2160
Lot: all

MD: Cardiac cryosurgical system catheter

MD: Cardiac cryosurgical system catheter

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

Vk_20241011_03

(Updated )

Cepheid

XpertXpressCoV-2plus
Model: XP3SARS-COV2-10
Lot: See FSN

XpertXpressCoV-2/Flu/RSVplus
Model: P3COV2/FLU/RSV-10
Lot: See FSN

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

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

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

Vk_20240924_01

Epic Systems Corporation

Regulated Decision Support Framework
SW-Version: See FSN

MD: Clinical management support software

EN-1

Vk_20241010_08

Fresenius Kabi AG

Orchestra- and Pilot-Series
Model: Z174025, Z174031

MD: Bedside syringe pump

DE-1
FR-1

Vk_20241011_01

Datex-Ohmeda Inc.

Giraffe OmniBed Carestation
S/N: see FSN

Giraffe OmniBed
S/N: see FSN

MD: Conventional infant incubator

MD: Conventional infant incubator

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

Vk_20241011_20

(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 )

Siemens Healthcare Diagnostics Inc.

Atellica IM Erythropoietin (EPO)
Model: 10733006
Lot: 53982039, 55439041
S/N: N/A

ADVIA Centaur Erythropoietin (EPO)
Model: 10995096
Lot: 53984040, 55443042

IVD: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

IVD: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

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

Vk_20240130_16

ORTHOPLUS SAS

Pediatric Labial Interceptor with Stop
Model: D595 010P

MD: Orthodontic Devices - Other

FR-1
EN-1

Vk_20240904_07

(Updated )

Arthrex INC

Femoral ACL Marking Hook, AM Portal, 7 mm Offset
Model: AR-1510F-02
Lot: 1068582412

MD: Surgical drill guide, reusable

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

Vk_20241002_16

Roche Diagnostics GmbH

CoaguChek PT Test
Model: 06688721070, 06688721016, 06688721019
Lot: 77409111, 77409112, 77409113

IVD: Prothrombin Time Rt & Poc

DE-1
FR-1
IT-1

Vk_20240925_03

SINOVO health solutions GmbH

mylife App
SW-Version: 2.4.0

MD: General Medicine Therapeutic Treatment Instruments - Software Accessories

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

Vk_20241004_13

B. Braun Melsungen AG

Infusomat Space Line ENFit
Model: 8250830SP
Lot: 23L27F0000, 22B16F0000, 23B21F0000, 23F21F0000

MD: Electric infusion pump administration set, single-use

DE-1

Vk_20241004_01

(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

Cook Incorporated

Approach Hydro ST Micro Wire Guide
Model: HMW-14-135-ST; G52937
Lot: 15735501, 15907468

MD: Peripheral vascular guidewire, manual

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

Vk_20240930_10

Agfa HealthCare

Enterprise Imaging XERO Viewer
SW-Version: software version 8.x

MD: Radiological PACS software

DE-1
FR-1
EN-1

Vk_20240924_15

ICU Medical

15mm Double Swivel Connector 10/BX
Lot: 4122008, 4138707

Portex orator speaking valve for tracheostomy tube 2/CA
Lot: 4097683, 4100700, 4107294, 4122007, 4131840

Nasopharyngeal Airway 6.0MM 10/BX
Lot: 4115880

Nasopharyngeal Airway 7.0MM 10/BX
Lot: 4097684, 4110350, 4115879, 4122013, 4130777, 4156815

Nasopharyngeal Airway 8.0MM 10/BX
Lot: 4107296, 4112944, 4125005, 4127687, 4141737, 4147168

15mm Y PIECE 10/CA
Lot: 4092461, 4147818, 4150795

MD: Tube/mask breathing circuit connector, single-use, sterile

MD: Tracheostomy tube speech valve

MD: Nasopharyngeal airway, single-use

MD: Nasopharyngeal airway, single-use

MD: Nasopharyngeal airway, single-use

MD: Heat/moisture exchanger, single-use

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

Vk_20240930_15

Integra LifeSciences Corp

Codman Surgical Strips
Model: 801449 , 801450 , 801451 , 801452 , 801453 , 801454 , 801455 , 801456 , 801457
Lot: All unexpired lot numbers ( 5 years expiration)

Codman Surgical Patties
Model: 801396 , 801397 , 801398 , 801399 , 801400 , 801401 , 801402 , 801403 , 801404 , 801406 , 801407 , 801408 , 801409
Lot: All unexpired lot numbers ( 5 years expiration)

MD: Neurosurgical sponge

MD: Neurosurgical sponge

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

Vk_20240927_13