Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2023 – 31.03.2023 Швейцарія

28.03.2023

(Updated 03.04.2023)

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Cortisol assay
Model: see FSN
Lot: see FSN
S/N: N/A

Atellica IM Cortisol
Model: see FSN
Lot: see FSN
S/N: N/A

IVD: Total cortisol IVD, kit, chemiluminescent immunoassay

IVD: Total cortisol IVD, kit, chemiluminescent immunoassay

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

Vk_20230321_25

24.03.2023

(Updated 31.03.2023)

Covidien llc

Shiley Adult FlexibleTracheostomy Tube
Model: 4CN65A, 4CN65R, 4UN65A, 4UN65R, 5CN70A, 5CN70R, 5UN70A, 5UN70R, 6CN75A, 6CN75R, 6UN75R, 7CN80A, 7CN80R, 7UN80A, 7UN80R, 8CN85A, 8CN85R, 8UN85A, 8UN85R, 9CN90R, 9UN90R, 10CN10R, 10UN10A, 10UN10R
S/N: See FSN

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

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

Vk_20230324_11

17.03.2023

(Updated 31.03.2023)

VitreQ B.V.

CryoTreq
Model: CT00.D01
Lot: See FSN
SW-Version: not applicable

MD: Ophthalmic cryosurgical system, mechanical

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

Vk_20230313_14

31.03.2023

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
FR-1
IT-1

Vk_20230221_14

30.03.2023

Ortho Clinical Diagnostics

Ortho BioVue System Control (RH/K II) Cassette
Model: 707250
Lot: RHP123J

IVD: Haematology / Haemostasis / Immunohaematology / Histology / Cytology

FR-1
EN-1

Vk_20230327_01

28.02.2023

(Updated 30.03.2023)

MicroPort CRM S.r.l.

ENO/TEO/OTO/KORA 250
Model: ENO SR, ENO DR, TEO SR, TEO DR, OTO SR, OTO DR, KORA 250 SR, KORA 250 DR
S/N: for Switzerland: 206CS56D, 209CS0B2, 206CS6D4, 206CU70B, 206CS3B1, 207CS120

AIMD: Dual-chamber implantable pacemaker, demand; Dual-chamber implantable pacemaker, rate-responsive; Single-chamber implantable pacemaker, fixed-rate/demand; Single-chamber implantable pacemaker, rate-responsive

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

Vk_20230228_09

26.07.2021

(Updated 30.03.2023)

ACUTRONIC Medical Systems AG

fabian +nCPAP evolution
Model: 122001, 122012

fabian Therapy evolution
Model: 121001, 121012

Fabian HFO
Model: 111001, 111001.01, 112001, 113001

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

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

Vk_20210712_10

16.03.2021

(Updated 30.03.2023)

Medtronic MiniMed

MiniMed 780G Insulin Pump
Model: MMT-1885, MMT-1886; Kit 780G models: MMT-1895; MMT-1896
Lot: n.a.
S/N: n.a.
SW-Version: 6.5

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

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

Vk_20210316_01

05.02.2021

(Updated 30.03.2023)

NuVasive Specialized Orthopedics, Inc.

PRECICE System
Model: See Attachment 1

MD: Long bone distraction rod, magnetic

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

Vk_20210202_09

10.03.2023

(Updated 29.03.2023)

Inpeco S.A.

Aptio Automation

IVD: Specimen processing instrument IVD

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

Vk_20230303_30

10.03.2023

(Updated 29.03.2023)

Inpeco S.A.

ACCELERATOR a3600

IVD: Specimen processing instrument IVD

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

Vk_20230303_29

10.03.2023

(Updated 29.03.2023)

Inpeco S.A.

FlexLab

IVD: Specimen processing instrument IVD

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

Vk_20230303_27

28.03.2023

Boston Scientific Corporation

IntellaNav StablePoint Ablation Catheter
Model: Please refer to the FSN
Lot: Please refer to the FSN
S/N: Please refer to the FSN
SW-Version: N/A

MD: Cardiac radio-frequency ablation system catheter

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

Vk_20230324_20

27.03.2023

(Updated 28.03.2023)

Samsung Electronics Co., Ltd

GM85
Model: GM85
S/N: 5149M3IJ100001F

MD: Mobile basic diagnostic x-ray system, digital

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

Vk_20230308_16

27.03.2023

EKU Elektronik GmbH

NO-Applikationsgerät

MD: Nitric oxide delivery unit, system-based

DE-1

Vk_20230327_35

27.03.2023

Datascope Corp.

CARDIOSAVE® Hybrid Intra-Aortic Balloon Pump
Model: 0998-00-0800-XX, 0998-UC-0800-XX
Lot: N/A
S/N: All Cardiosave serial numbers distributed March 6, 2012 to present

MD: Intra-aortic balloon pump

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

Vk_20230327_30

27.03.2023

DH Healthcare GmbH

ORBIS Medication
SW-Version: 3.17

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20230320_06

22.03.2023

(Updated 27.03.2023)

NEXUS / DIS GmbH

NEXUS / MEDIKATION
SW-Version: 19, 20, 22

MD: General Medicine Therapeutic Treatment Instruments – Medical Device Software

DE-1
FR-1
IT-1

Vk_20230223_18

21.03.2023

(Updated 24.03.2023)

Draeger Medical Systems, Inc.

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

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

MD: Centralized patient monitor

MD: Centralized patient monitor

DE-1
FR-1
IT-1

Vk_20230320_03

23.03.2023

Medtronic Inc.

SenSight Extension Tunneler Kit
Model: B31030
Lot: See FSN

AIMD: Subcutaneous tunneller, single-use

DE-1
FR-1

Vk_20230317_14

23.03.2023

EUROIMMUN Medizinische Labordiagnostika AG

Dengue-Viren-NS1-ELISA
Model: EQ 266a-9601-1
Lot: E220908AN, E220802AQ

IVD: Dengue Virus

DE-1

Vk_20230316_19

22.03.2023

SPINEART SA

LATERAL LUMBAR TI-LIFE PLATE
Model: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S, JLT-PL 02 18-S, JLT-PL 02 20-S, JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S, JLT-PL 04 20-S
Lot: See FSN

MD: Spinal fixation plate, non-bioabsorbable

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

Vk_20230317_20

28.02.2023

(Updated 22.03.2023)

Cook Incorporated

AdvanceMicro – 14UltraLow-ProfilePTA BalloonCatheter
Model: PTA3-14-150-2.5-8, PTA3-14-150-2.5-3, and ULT16.0-38-25-P-6S-LMCL; G26677, G26646, and G07340
Lot: 14110999, 14111001, NS13527160, 14012749, and 14007378

MD: Peripheral angioplasty balloon catheter, basic

IT-1
EN-1

Vk_20230227_17

22.03.2023

Spiggle & Theis Medizintechnik GmbH

ENT single-use suction tubes
Model: 3010025, 3010030, 3010040
Lot: 20181130

MD: Suction Tips, General-Purpose

DE-2
EN-2

Vk_20220816_12

02.12.2020

(Updated 22.03.2023)

Hitachi High-Tech Corporation

cobas 8000
Model: 05641446001
SW-Version: all

cobas pro
Model: 08464502001
SW-Version: all

cobas c 513
Model: 07649142001
SW-Version: all

IVD: Multi-modality clinical specimen analysis system IVD

IVD: Multi-modality clinical specimen analysis system IVD

IVD: Multi-modality clinical specimen analysis system IVD

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_20201130_17

21.03.2023

Molzym GmbH & Co. KG

Micro-Dx
Model: U-200-024, U-200-48
Lot: See FSN

MolYsis-SelectNA Plus
Model: D-450-48

IVD: Fully Automated Pathogen Diagnosis

IVD: Instrument for fully automated microbial DNA extraction

DE-1
EN-1

Vk_20230317_26

21.03.2023

Quidel Corporation

MicroVue C1-Inhibitor Plus EIA
Model: A037
Lot: 213783
SW-Version: Not applicable

IVD: Complement Component C1 inhibitor

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

Vk_20230314_18

14.03.2023

(Updated 16.03.2023)

Medex

Qitexio 20ml Luer Lock Syringe
Model: QIT003
Lot: TC2019-2, TC2047-1

MD: General-purpose syringe, single-use

DE-1
FR-1
EN-1

Vk_20230307_25

16.03.2023

Uniogen Oy / Abacus Diagnostica Oy

GenomEra GBS Assay Kit
Model: CDX-60-01-20, CDX-60-01-40
Lot: 16025, 16026, 16028, 16029, 16030

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

EN-1

Vk_20230303_38

07.03.2023

(Updated 16.03.2023)

Limacorporate S.p.a.

SMR Glenoid TT MB Peg S-R Medium, Long, X-Long
Model: 1375.14.652; 1375.14.653; 1375.14.654
Lot: All lot numbers belonging to version 00 of the model numbers cited.

MD: Shoulder glenoid fossa prosthesis, prefabricated

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

Vk_20230303_36

15.03.2023

Intuitive Surgical, Inc

Da Vinci X / Xi Surgical System
Model: IS4000, IS4200
S/N: System: SK5599; USM: 10122504
SW-Version: Not applicable

MD: Robotic surgical system

DE-1
EN-1

Vk_20230309_12

15.03.2023

Philips Medical Systems DMC GmbH

CombiDiagnost R90
Model: 709030, 709031
S/N: See FSN

ProxiDiagnost N90
Model: 706100, 706110
S/N: See FSN

MD: Radiographic/fluoroscopic unit, mobile

MD: Radiographic/fluoroscopic unit, mobile

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

Vk_20230308_13

15.03.2023

CooperSurgical Inc.

Global Total LP single step medium
Model: H5GT-060
Lot: 221118-010694

MD: IVF medium

DE-1
FR-1
IT-1

Vk_20230215_02

14.03.2023

Siemens Healthcare Diagnostics Inc.

Atellica DCA Analyzer
Model: 11419264, 11419267, 11561560, 11561561, 11419268

Atellica DCA ACR Reagent Kit
Model: 10888779

IVD: Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

IVD: Albumin/creatinine ratio (ACR) IVD, kit, nephelometry/turbidimetry

EN-1

Vk_20230310_10

14.03.2023

FUJIFILM medwork GmbH

Dilatation Balloons (DIL1-A1-Series)
Model: DIL1-A1-06-40-23-35, DIL1-A1-08-40-23-35, DIL1-A1-10-40-23-35, DIL1-A1-12-60-23-35, DIL1-A1-14-60-23-35, DIL1-A1-16-60-23-35, DIL1-A1-18-60-23-35, DIL1-A1-20-60-23-35
Lot: see FSN

MD: Dilators

DE-1

Vk_20230310_02

01.03.2022

(Updated 14.03.2023)

Edwards Critical-Care Division

Fore-Sight Elite Tissue Oximeter Module
Model: HEMFSM10
S/N: All serial numbers

Fore-Sight Elite Absolute Tissue Oximeter Monitor
Model: 01-06-3000
S/N: All serial numbers

MD: General-purpose multi-parameter bedside monitor

MD: Tissue saturation oximeter

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

Vk_20220301_01

23.02.2023

(Updated 13.03.2023)

Biosense Webster Inc

HELIOSTAR Balloon Ablation Catheter
Model: D138904
Lot: All lots
SW-Version: N/A

MD: Cardiac mapping catheter, percutaneous, single-use

DE-1
FR-1
EN-1

Vk_20230216_10

10.03.2023

Aesculap AG

CAIMAN, Endoscopic electrosurgical handpiece
Model: PL770SU, PL771SU, PL775SU
Lot: 52802809, 52799614, 52803165, 52781985, 52785146, 52800998, 52808586, 52793444

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

DE-1
FR-1

Vk_20230309_10

10.03.2023

Armstrong Medical Limited

AquaVent Neo Neonatal Heated CPAP System
Model: see FSN
Lot: see FSN

MD: Ventilator breathing circuit, single-use

EN-1

Vk_20230306_15

10.03.2023

Waldemar Link GmbH & Co. KG

Link Sled Prosthesis – Femoral Components & Tibial Plateaus
Model: see FSN
Lot: N/A

MD: Uncoated unicondylar knee femur prosthesis; Coated unicondylar knee femur prosthesis; Uncoated unicondylar knee tibia prosthesis, polyethylene; Uncoated unicondylar knee tibia prosthesis, metallic; Coated unicondylar knee tibia prosthesis

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

Vk_20230301_03

02.03.2023

(Updated 10.03.2023)

Ganshorn Medizin Electronic GmbH

Spirometer-diagnostics
Model: SP Plus / 013400563
S/N: See FSN
SW-Version: USCntl 2.26.1

MD: Diagnostic spirometer, professional

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

Vk_20230227_14

06.03.2023

(Updated 10.03.2023)

HYPHEN BioMed SAS

BIOPHEN PROTEIN C LRT
Model: 221211
Lot: FA07491F, FA18431G

IVD: Coagulation Inhibitors/thrombophilia Markers

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

Vk_20230223_13

28.02.2023

(Updated 10.03.2023)

Philips Medical Systems Nederland B.V

SmartPerfusion; 2D Perfusion
Model: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067, 722068, 722078, 722079, 722223, 722224, 728225, 722226, 722227 and 722228

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

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

Vk_20230221_28

05.01.2023

(Updated 10.03.2023)

Siemens Healthcare GmbH

Luminos dRF Max
Model: 10762471

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

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

Vk_20221221_12

09.03.2023

Philips Healthcare (Suzhou) Co., Ltd.

DigitalDiagnost
Model: 712201, 712204
S/N: See FSN

MD: Stationary basic diagnostic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20230301_24

08.03.2023

Ottobock SE & Co. KGaA

Genu Arexa PCL
Model: 50K14
Lot: all

MD: Knee support orthosis

DE-1

Vk_20230302_14

08.03.2023

Radiometer Medical

AQURE system
Model: 933-599
SW-Version: 2.5.2 and newer versions

IVD: Medical equipment clinical data interfacing software

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

Vk_20230301_23

08.03.2023

Hamilton Bonaduz AG

Hamilton-C6
Model: 160021

MD: Respiratory And Anaesthesia Devices – Other

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

Vk_20230208_14

04.10.2022

(Updated 08.03.2023)

DiaMed GmbH

IH-500
Model: 001500 / 001500RECOND

IVD: Immunohaematology/blood bank analyser IVD

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_20220921_01

07.03.2023

MAQUET Cardiopulmonary GmbH

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

MD: Cardiopulmonary bypass system heat exchanger, reusable

DE-1
EN-1

Vk_20230306_19

07.03.2023

Brainlab AG

Cirq Arm System 2.0
Model: 56500

MD: Surgical instrument assist arm system, power-adjusted

DE-1
EN-1

Vk_20230306_18

07.03.2023

Boston Scientific Corporation

Habib EndoHPB Bipolar Radiofrequency Catheter
Model: M00500070
Lot: All
S/N: All

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

DE-1
FR-1
EN-1

Vk_20230303_01

07.03.2023

HUMAN Gesellschaft für Biochemica und Diagnostica mbH

IMTEC CIC IgG ELISA
Model: ITC59031
Lot: 21003
S/N: n.a.
SW-Version: n.a.

IVD: Circulating immune complex kit

DE-1

Vk_20230302_01

07.03.2023

Avanos Medical, lnc.

BALLARD* Oral Care Swabs
Model: 12251
Lot: 20054925, 20061148, 20063691, 20072187, 20072191, 20075090, 20075094, 20082082, 20082083, 20082084, 20054927

MD: Oral care kit, single-use

DE-1-CUST
DE-1-DIST
FR-1-CUST
FR-1-DIST
IT-1-CUST
IT-1-DIST
EN-1-CUST
EN-1-DIST

Vk_20230301_08

14.02.2023

(Updated 07.03.2023)

Caesarea Medical Electronics Limited

BD BodyGuard MicroSets
Model: See FSN
Lot: all

MD: Electric infusion pump administration set, Blood transfusion set, Intravenous administration tubing extension set

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

Vk_20230207_14

30.12.2022

(Updated 07.03.2023)

Medtronic Inc.

Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface
Model: BB811, BB841, CB811, CB841
S/N: Between 8111483548 and 8113999999

MD: Extracorporeal membrane oxygenator

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

Vk_20221221_01

06.03.2023

St. Jude Medical

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

MD: Aortic heart valve bioprosthesis

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

Vk_20230227_28

03.03.2023

ENDALIS

End-ball ENDT110
Model: ENDT110
Lot: 22-0001, 22-0002, 22-0003

MD: Appetite-suppression gastric balloon

EN-1

Vk_20220607_17

09.02.2022

(Updated 02.03.2023)

PULSION Medical Systems SE

PiCCO Monitoring Kit + ProAQT Sensor
Model: see Annex II
Lot: see Annex II

MD: Invasive blood pressure transducer set

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

Vk_20220203_28

01.03.2023

RAL Diagnostics

MCDh1
Model: 313590-2500
Lot: L84428 ; L25918; K42236 ; L14135

IVD: Biological stain IVD

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

Vk_20230214_05

24.08.2022

(Updated 01.03.2023)

Planer Limited

Humidifier Bottle and Syringe filter kit for BT37
Model: AY102295, AY200246
Lot: see FSN

MD: Non-heated respiratory humidifier

DE-1
FR-1
EN-1

Vk_20220815_17

28.02.2023

Gynemed GmbH & Co. KG

Denu Tips
Model: GY-XXX/XX
Lot: 44200203, 44200203A, 44200303A, 44200403, 44210103, 44210203, 44210303, 44210403, 44220103, 44220203, 44220303, 44220403

Oocyte aspiration Needles
Model: GY-XXXXXXLF(-XXX)
Lot: see FSN

MD: Assisted reproduction microtool

MD: IVF oocyte aspiration needle, single-use

EN-1

Vk_20230223_14

28.02.2023

Siemens Healthcare Diagnostics Inc.

ADVIA Autoslide Giemsa Stain
Model: 10718483
Lot: L61225

IVD: Giemsa staining solution IVD

EN-1

Vk_20230221_15

23.02.2023

(Updated 28.02.2023)

Rehasense Sp z o.o.

Router, Navigator, EVA, Navigon
Model: See FSN
S/N: See FSN

MD: Walkers, Wheeled

DE-1
FR-1
EN-1

Vk_20230214_17

27.09.2022

(Updated 28.02.2023)

Siemens Healthcare Diagnostics Inc.

Lithium (Li) reagents
Model: Atellica CH Lithium (Li) 11097535
Lot: all

Lithium_2 (LITH_2) reagents
Model: Atellica CH Lithium_2 (LITH_2) 11532401
Lot: all

IVD: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy

IVD: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy

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

Vk_20220921_10

20.02.2023

(Updated 27.02.2023)

Abbott Diabetes Care Ltd

FreeStyle Libre 3 App
Model: 72229-01
SW-Version: 3.4.1 (or earlier)

FreeStyle LibreLink App
Model: 71809-01
SW-Version: 2.8.2 (or earlier)

MD: Percutaneous interstitial-fluid glucose monitoring system, electrochemical

MD: Percutaneous interstitial-fluid glucose monitoring system, electrochemical

DE-1.1
DE-1.2
DE-1.3
DE-2.1
DE-2.2
DE-2.3
FR-1.1
FR-1.2
FR-1.3
FR-2.1
FR-2.2
FR-2.3
IT-1.1
IT-1.2
IT-1.3
IT-2.1
IT-2.2
IT-2.3

Vk_20230210_14

09.01.2023

(Updated 27.02.2023)

Inari Medical, Inc.

Triever24
Model: 22-101
Lot: 22100019, 22100020, 22100024, 22100025, 22100026

MD: Thrombectomy suction catheter

DE-1
EN-1

Vk_20221229_11

03.08.2022

(Updated 27.02.2023)

Medtronic Inc.

Vanta LT Clinician Programmer Application
Model: A71200
S/N: All
SW-Version: 2.0.2455

AIMD: Multiple active implantable device programmer

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

Vk_20220729_03

03.08.2022

(Updated 27.02.2023)

Medtronic Inc.

Vanta LT Clinician Programmer Application
Model: A71200
S/N: All
SW-Version: 2.0.2455

AIMD: Multiple active implantable device programmer

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

Vk_20220729_02

24.02.2023

Drägerwerk AG & Co. KGaA

ICM
Model: MS17160
SW-Version: 9.1-13.0.1

MD: Data Management Systems, Patient

DE-1

Vk_20230214_22

30.01.2023

(Updated 24.02.2023)

DiaMed GmbH

IH-1000
Model: 001000, 001000RECOND
S/N: All
SW-Version: v04.08.11

IVD: Immunohaematology/blood bank analyser IVD

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

Vk_20230123_27

22.02.2023

CareDx AB

Olerup QTYPE 11
Model: 201.701-03/10
Lot: E052, E053, E054, E055, E056, E057, E058, E059, E060, E061, E062, E063

IVD: Hla Antigen Typing

DE-1
FR-1
IT-1

Vk_20230222_12

08.02.2023

(Updated 22.02.2023)

Randox Laboratories Ltd

Randox CRP
Model: CP7950; CP3826
Lot: see FSN
SW-Version: N/A

IVD: C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

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

Vk_20230206_18

21.02.2023

B. Braun Melsungen AG

INF.SP.LINE, TRANS, PVC, LL, 250CM-EU
Model: 8270066SP-01
Lot: see comments

MD: Electric infusion pump administration set, single-use

DE-1
FR-1
IT-1

Vk_20230202_20

21.02.2023

Carnamedica Sp. z o.o.

StoreProtect
Model: SPRT
Lot: 120822

Belzer UW Cold Storage Solution
Model: BUWC, BUWC2000
Lot: 010722, 061022, 081222, 022422, 030222, 090122, 030322, 110922, 021822, 112122, 030722, 010322, 030422, 030822, 123021, 030922, 030122, 082222, 082322

Belzer MPS
Model: BMPSC
Lot: 110822, 121721, 121621

MD: General-purpose donor-organ preservation/transport system

MD: General-purpose donor-organ preservation/transport system

MD: General-purpose donor-organ preservation/transport system

DE-1
FR-1
IT-1

Vk_20230125_09

20.02.2023

SINOVO health solutions GmbH

mylife App
SW-Version: 2.1.0

MD: General Medicine Diagnosis And Monitoring Instruments

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

Vk_20230215_01

20.02.2023

Siemens Healthcare Diagnostics Products GmbH

Test Thrombin Reagent
Model: 10446598
Lot: see FSN

IVD: Thrombin time (TT) IVD, kit, clotting

DE-1
FR-1
IT-1

Vk_20230213_26

17.02.2023

Nidek & Co Ltd

Preloaded EyeCee One IOL
Model: EYEC1CRYPRE, EYEC1PRE
Lot: All
S/N: All

MD: Posterior-chamber intraocular lens, pseudophakic

DE-1
FR-1
IT-1

Vk_20230209_11

17.02.2023

Telemis S.A.

Telemis-Medical
SW-Version: Up to version 4.96 (latest patch 08)

MD: Picture Archiving And Communication Systems

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

Vk_20230131_16

17.02.2023

Emergent BioSolutions Inc

Reactive Skin Decontamination Lotion (RSDL)
Model: F5410ENG
Lot: 23005061
S/N: N/A
SW-Version: N/A

MD: Towelettes, Personal, Skin/Personal Gear Decontamination

EN-1

Vk_20230113_05

15.02.2023

Medtronic Sofamor Danek Inc.

Grafton Putty, Grafton Crunch, Grafton Flex, Grafton Orthoblend, Grafton Matrix, Grafton Matrix Strips, Grafton Plus Paste, Grafton DBF, Grafton DBF Inject, Grafton Gel, Accelerate Grafton DB, XPANSE Bone Insert
Model: see FSN
Lot: see FSN

: Demineralized bone allografts

DE-1
FR-1
IT-1

Vk_20230209_31

15.02.2023

Given Imaging Inc.

SmartPill SmartBar
Model: FGS-0505; 73614B, 74200B, 74800B

MD: Gastrointestinal telemetric monitoring system

DE-1

Vk_20230208_27

14.02.2023

St. Jude Medical

CardioMEMS PA Sensor and Delivery System
Model: CM2000
S/N: All serial numbers
SW-Version: CM3000 software version. I2.2018.1105-r8829

AIMD: Implantable pulmonary artery pressure monitoring system

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

Vk_20230208_16

14.02.2023

St. Jude Medical

CardioMems Hospital and Patient Electronic System
Model: CM1000, CM1100, CM3000
S/N: All serial numbers

AIMD: Implantable pulmonary artery pressure monitoring system

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

Vk_20230208_15

08.02.2023

(Updated 10.02.2023)

Mobidiag Ltd.

Novodiag CarbaR+
Model: V2; NVD-CRB-012
Lot: Kit lot 00241726 (Cart lot 00241466) , Kit lot 00442558 (Cart lot 00442365), Kit lot 00542815 (Cart lot 00542611)
SW-Version: V5.0.0

IVD: Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
FR-1
EN-1

Vk_20230202_13

16.01.2023

(Updated 10.02.2023)

Respironics Inc.

V680 Ventilator

MD: General-purpose intensive-care ventilator

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

Vk_20230116_17

08.02.2023

(Updated 09.02.2023)

Physio-Control, Inc.

LIFEPAK CR2 defibrillator
Model: see FSN
S/N: see FSN

MD: Non-rechargeable public semi-automated external defibrillator

DE-1
EN-1

Vk_20230203_21

09.02.2023

TRACOE medical GmbH

TRACOE experc Set twist
Model: see FSN
Lot: Manufacturing date from 27Dec2021 to 12Jan2023

TRACOE experc Set vario
Model: see FSN
Lot: Manufacturing date from 27Dec2021 to 12Jan2023

TRACOE experc Set twist plus
Model: see FSN
Lot: Manufacturing date from 27Dec2021 to 12Jan2023

MD: Tracheostomy kit, single-use

MD: Tracheostomy kit, single-use

MD: Tracheostomy kit, single-use

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

Vk_20230131_11

06.12.2022

(Updated 09.02.2023)

Medtronic Inc.

Vanta LT Clinician Programmer Application
Model: A71200
S/N: All
SW-Version: 2.0.2455

AIMD: Multiple active implantable device programmer

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

Vk_20221130_18

08.02.2023

Beckman Coulter , Inc.

Access 2 Immunoassay Analyzer
Model: 81600N

Access 2 Immunoassay Analyzer, Refurbished
Model: 386220

Access 2 Immunoassay Analyzer-Refurbished
Model: A65531

Access 2 Section, DxC 600i Packaged
Model: A25640

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Chemiluminescent immunoassay analyser IVD

DE-1
FR-1
EN-1

Vk_20230203_06

07.02.2023

DH HealthCare GmbH

ORBIS Medication
SW-Version: 3.x

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20230206_17

07.02.2023

Intuitive Surgical, Inc

SureForm 45, SureForm 45 Curved-Tip, SureForm 60
Model: 480445- 04; 480545-04; 480460-09
Lot: See FSN

MD: Robotic surgical cutting stapler, single-use

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

Vk_20230206_16

07.02.2023

Siemens Healthcare GmbH

ARTIS pheno
Model: 10849000
S/N: ARTIS pheno systems with software version VE10B in combination with a Siemens Healthineers table or a Trumpf/MAQUET table (OEM)
SW-Version: VE10B

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20230202_29

07.02.2023

GE Healthcare Finland Oy

Frame F2-01
Model: 5861293
S/N: SUT xx xx xxxx xx

MD: Patient monitoring system module rack

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

Vk_20230201_02

01.12.2022

(Updated 07.02.2023)

Clinical Innovations LLC

Fetal Measurements
Model: 989803137631; N/A
Lot: N/A
S/N: N/A
SW-Version: N/A

MD: Foetal scalp electrode, spiral

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

Vk_20221124_25

06.02.2023

bioMérieux SA

Mueller Hinton E Agar
Model: 413822, 413824, 413825, 417680
Lot: see FSN

IVD: Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

DE-1
FR-1
EN-1

Vk_20230125_01

03.02.2023

Miele & Cie. KG

Steelco PWD
Model: 8626, 8628

MD: Cleaning And Disinfection Equipment

DE-1
EN-1

Vk_20230126_01

01.02.2023

(Updated 02.02.2023)

Siemens Healthcare Diagnostics Inc.

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

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

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

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

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

IVD: Total protein IVD, kit, enzyme spectrophotometry

IVD: Triglyceride IVD, kit, enzyme spectrophotometry

IVD: Triglyceride IVD, kit, enzyme spectrophotometry

DE-1
FR-1
EN-1

Vk_20230127_24

02.02.2023

Covidien llc

Tri-Staple 2.0
Model: SIG60AXT: Tri-Staple 2.0 Black Intelligent Reload 60mm Extra Thick
Lot: N2D0004Y, N2D0195Y, N2D0002Y

MD: Surgical staple loading unit, non-cutting

DE-1
FR-1
EN-1

Vk_20230125_23

31.01.2023

(Updated 02.02.2023)

Ivor Shaw Ltd. trading as Pennine Healthcare

Link Yankauer Sets
Model: See FSN
Lot: See FSN

Suction Connecting Tubing
Model: See FSN
Lot: See FSN

MD: Surgical/emergency suction cannula, non-illuminating, single-use

MD: Suction/irrigation tubing, single-use

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

Vk_20230124_01

31.01.2023

Drägerwerk AG & Co. KGaA

Flex Ventilation Hose
Model: MP00303, MP04903, MP00305
Lot: Multiple

MD: Tubing

DE-1

Vk_20230127_21

30.01.2023

(Updated 31.01.2023)

Weinmann Emergency Medical Technology GmbH + Co. KG

MEDUMAT Standard 2
Model: 28710
S/N: Devices up to and including serial number SN 19645 are affected.

MD: Transport electric ventilator

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

Vk_20230117_08

27.06.2019

(Updated 31.01.2023)

Datascope Corp.

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Model: 0998-00-0800-XX, 0998-UC-0800-XX, 0998-00-3013-XX, 0998-00-3023-XX; N/A
Lot: N/A
S/N: All Cardiosave serial numbers distributed March 6, 2012 to present All CS100 and CS300 serial numbers distributed March 24, 2003 to present
SW-Version: N/A

MD: Intra-aortic balloon pump

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_20190619_15

22.03.2022

(Updated 30.01.2023)

ELITech Clinical Systems SAS

MAGNESIUM XB
Model: MGXB-0600; MGXB-0250; MGXB-M430
Lot: see FSN

IVD: Magnesium (Mg2+) IVD, kit, spectrophotometry

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

Vk_20220317_02

08.03.2022

(Updated 30.01.2023)

Abbott Molecular Inc.

Alinity m HBV AMP Kit
Model: 08N47-090; (US and Hong Kong only: 08N47-095)
Lot: see FSN

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

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

Vk_20220308_02

21.12.2022

(Updated 27.01.2023)

Phadia AB

Phadia 200, Fluorescent immunoassay analyser IVD, laboratory
Model: 12-4300-00
S/N: All

IVD: Fluorescent immunoassay analyser IVD, laboratory

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

Vk_20221213_28

23.01.2023

(Updated 26.01.2023)

Scewo AG

Scewo Bro
Lot: see FSN
S/N: see FSN

MD: Wheelchairs, Powered

DE-1
EN-1
EN-2

Vk_20230116_18

27.12.2022

(Updated 26.01.2023)

Philips Goldway (Shenzhen) Industrial Inc.

Efficia External Padles
Model: 989803196431;
Lot: see FSN

MD: External defibrillator electrode, adult, reusable

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

Vk_20221223_03

25.01.2023

Schiller AG

CARDIOVIT MS-2007; MS-2010; MS-2015
Model: 0A.101000: 3.900790, 3.900792; 0.090000: 3.900800, 3.900804, 3.900805; 0A.100000: 3.900829, 3.900830, 3.900833
SW-Version: versions below v3.10

CARDIOVIT AT-102
Model: 0.075000: 3.912300, 3.912301, 3.912302
SW-Version: all versions

CARDIOVIT AT-10 plus
Model: 0.173000: 3.920603, 3.920610
SW-Version: versions below v2.60

CARDIOVIT AT-104 PC
Model: 0.040000: 3.910454, 3.910456; 0.040100: 3.910454, 3.910456
SW-Version: all versions

CARDIOVIT CS-200
Model: 0.030000: 3.920250, 3.920200; 0.030100: 3.920250, 3.920200
SW-Version: all versions

CARDIOVIT AT-102 plus
Model: 0.075000: 3.912300, 3.912301, 3.912302
SW-Version: versions below v1.20

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiograph, professional, multichannel

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

Vk_20230124_11

24.01.2023

(Updated 25.01.2023)

Rayner Intraocular Lenses Limited

RayOne EMV
Model: RAO200E

MD: Posterior-chamber intraocular lens, pseudophakic

DE-1
FR-1
EN-1

Vk_20230124_09

25.01.2023

Drägerwerk AG & Co. KGaA

NovaStar plus, Nova Star TS
Model: see FSN

MD: Masks

DE-1
FR-1

Vk_20230120_16

25.01.2023

Teleflex Medical SDN BHD

Rüsch EndoGuide T
Model: 503100-000060, 503110-000060
Lot: See FSN

MD: Endotracheal tube introducer, single-use

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

Vk_20230120_01

25.01.2023

Medtronic MiniMed

MiniMed 508 Insulin Pump
S/N: All
SW-Version: All

MiniMed Paradigm Veo
Model: MMT-554, MMT-754
S/N: All
SW-Version: 2.6A or lower

MiniMed Paradigm Insulin Pump
Model: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-722
S/N: All
SW-Version: All

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

DE-1.1
DE-1.2
EN-1.1
EN-1.2

Vk_20230119_18

25.01.2023

B. Braun Melsungen AG

PROSET MULTIPACK SYRINGES
Model: 4185242, 4187250, 4890957
Lot: see FSN

MD: Intravenous line stopcock

DE-1

Vk_20230117_07

22.02.2022

(Updated 25.01.2023)

RaySearch Laboratories AB (publ)

RayStation
Model: RayStation 4 – 11B and RayPlan 1, 2, 7 – 11B and Service Packs
SW-Version: see FSN

MD: Radiation therapy software

DE-1 Information Only
FR-1 Information Only
IT-1 Information Only
EN-1 Information Only
EN-2 Current

Vk_20220217_70

23.01.2023

FUJIFILM Irvine Scientific, Inc

Oil for Embryo Culture
Model: 9305
Lot: 0000011351, 0000011367, 0000015999, 0000016001

MD: Devices For Assisted Reproduction

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

Vk_20230123_09

30.11.2022

(Updated 23.01.2023)

X-Nav Technologies, LLC

X-Guide System X-Mark Probe Tool
Model: P010673
Lot: 2007010010

MD: Surgical Navigation Instruments – Hardware Accessories

DE-1
FR-1

Vk_20221124_06

20.01.2023

AIR LIQUIDE MEDICAL SYSTEMS

MONNAL T60
Model: KA010000
S/N: All
SW-Version: V2.8.x

MONNAL T60 Advanced
Model: KA017128
S/N: All
SW-Version: V1.2.x

MD: Transport electric ventilator

MD: Transport electric ventilator

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

Vk_20230111_03

19.01.2023

B. Braun Melsungen AG

Original Perfusor Line
Model: 8250146, 8255067, 8272565, 8722935, 8723017, 8723018, 8723021, 8723025, 8723026, 8723060
Lot: see FSN

MD: Intravenous administration tubing extension set

DE-1
FR-1
IT-1

Vk_20230116_20

12.01.2023

(Updated 19.01.2023)

Johnson & Johnson International

Coated VICRYL PLUS – Antibacterial suture
Model: VCP1226H
Lot: SJBCGZS0

MD: Polyester suture, bioabsorbable, multifilament, antimicrobial

DE-1
EN-1

Vk_20230104_05

24.11.2022

(Updated 19.01.2023)

VWR International

FORMALIN 10% Buffered Q Path
Model: VWRQFOR0020AF59001
Lot: 220707C003

IVD: Fixative, formalin

DE-1
EN-1
EN-2

Vk_20221109_13

18.01.2023

B. Braun Melsungen AG

INF.SP.LINE, TRANS, PVC, LL, 250CM-EU
Model: 8270066SP-01
Lot: 22F19E8ST5; 22H25E8ST5

MD: Electric infusion pump administration set, single-use

DE-1
IT-1

Vk_20230111_21

17.01.2023

Sofradim Production

PARIETEX
Model: PCO2H3
Lot: PVE0194M

MD: Extra-gynaecological surgical mesh, composite-polymer

DE-1.0

Vk_20230111_20

10.01.2023

(Updated 16.01.2023)

Roche Diagnostics GmbH

Elecsys Troponin T hs
Model: 08469717190, 08469873190, 09315322190, 09315357190
SW-Version: n/a

Elecsys Troponin-T hs STAT
Model: 08469814190, 09315349190
SW-Version: n/a

IVD: Troponin I/t

IVD: Troponin I/t

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

Vk_20230109_15

09.01.2023

(Updated 16.01.2023)

GENERI BIOTECH s.r.o

gb PHARM UGT1A1
Model: 3253-025; 3253-050
Lot: 200086008; 200087011; 200087012

IVD: Inborn Gene Or Chromosome Alterations

DE-1
FR-1
EN-1

Vk_20221223_01

27.12.2022

(Updated 16.01.2023)

GENERI BIOTECH s.r.o

gb PHARM UGT1A1
Model: 3253-025; 3253-050
Lot: 200086006; 200086007; 200086008; 200087009; 200087010; 20008701; 200087012

IVD: Inborn Gene Or Chromosome Alterations

DE-1
FR-1
EN-1

Vk_20221221_33

19.12.2022

(Updated 16.01.2023)

VacSax Limited

Vommax
Model: 9310-003

MD: Fluid Collection Bags And Systems – Other

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

Vk_20221219_13

17.09.2021

(Updated 16.01.2023)

Datascope Corp.

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

MD: Intra-aortic balloon pump

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

Vk_20210913_06