Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2022 – 31.03.2022 Швейцарія

31.03.2022

Philips Medical Systems

Esophageal/Rectal Temperature Probes

MD: General-purpose patient temperature probe, reusable

EN-1

Vk_20220328_14

15.02.2022

(Updated 31.03.2022)

Advanced Medical Solutions Limited

LiquiBand Fix 8
Model: FX002
Lot: P00221182, P00221313, P00221396, P00221600, P00221756, P00221983, P00225605, P00225801, P00226740

MD: Surgical internal adhesive/sealant, synthetic polymer

DE-1
FR-1
IT-1

Vk_20220211_31

30.03.2022

Becton Dickinson S.A.

BD Plastipak Luer-Lok Syringe
Model: 300865
Lot: All

MD: General-purpose syringe, single-use

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

Vk_20220322_14

29.03.2022

Medtronic Inc.

IN.PACT Admiral
Model: See FSN
Lot: See FSN
S/N: All

MD: Peripheral angioplasty balloon catheter, drug-coated

DE-1
FR-1

Vk_20220323_14

25.03.2022

SHIMADZU Corporation

SONIALVISION G4
S/N: See FSN Serialnumbers

FLUOROspeed
S/N: See FSN Serialnumbers

MD: X-ray system, diagnostic

MD: X-ray system, diagnostic

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

Vk_20220316_15

21.02.2022

(Updated 24.03.2022)

Silony Medical GmbH

VERTICALE SI Screw Driver outer sleeve
Model: VI-6700.2
Lot: 798504IN0120; 798403IN0120; 023901IN0421; 024001IN0421

MD: General internal orthopaedic fixation system implantation kit

DE-1
EN-1

Vk_20220214_31

23.03.2022

Mathys Ltd Bettlach

balanSys REV stem screw
Model: 79.15.0062
Lot: all
S/N: 79.15.0062

MD: Knee femur stem prosthesis

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

Vk_20220318_18

23.03.2022

Draeger Medical Systems, Inc.

Infinity Central Station
SW-Version: VG2.1.2, VG2.1.2 SU1

MD: Centralized patient monitor

DE-1
FR-1
IT-1

Vk_20220311_29

22.03.2022

RaySearch Laboratories AB (publ)

RayCare
Model: 5A, 5A SP1, 5B
SW-Version: 5.0.0.60390, 5.0.1.60052, 5.1.0.61073

MD: Radiology information system application software

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

Vk_20220321_15

15.03.2022

(Updated 22.03.2022)

Getinge Disinfection AB

Getinge 9100-series – Washer Disinfector
Model: 9120E, 9122EW, 9125E, 9127E, 9128E, 9128EW
S/N: All 91xxE/ EW-models manufactured since start 2017 until 2021-12-21

MD: Surgical utensil washer/disinfector

DE-1
EN-1

Vk_20220311_31

16.03.2022

(Updated 22.03.2022)

Abbott Laboratories

ARCHITECT STAT Myoglobin Calibrators
Model: 2K43-01
Lot: 166000

IVD: Myoglobin IVD, calibrator

DE-1
EN-1

Vk_20220309_23

15.03.2022

(Updated 21.03.2022)

Abbott Vascular

20/30 INDEFLATOR, Plus 30 INDEFLATOR, Priority Packs
Model: 1000183, 1000184, 1000185, 1000186, 1000185-115, 1000186-115, 1003327
Lot: See FSN
SW-Version: Not Applicable

MD: Catheter/overtube balloon inflator, single-use

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

Vk_20220310_08

17.03.2022

HUM Gesellschaft für Homecare und Medizintechnik mbH

AEROpart O2-Brille B
Model: HSB01-B
Lot: Zeitraum: 01.01.2017 – 01.01.2022 (Alle Produkte der letzten 5 Jahre sind betroffen)

MD: Cannulae, Nasal, Oxygen Supply

DE-1
EN-1

Vk_20220308_14

08.12.2021

(Updated 17.03.2022)

Helena Biosciences Europe

V8
Model: V8; 800008, 800018, 800020

IVD: Electrophoresis analyser IVD, automated

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

Vk_20211206_06

16.03.2022

Z-Medica LLC (Subsidiary of Teleflex Incorporated)

QuikClot Interventional Hemostatic Bandage
Model: 183, 188
Lot: Refer to FSN

MD: Non-organic haemostatic agent

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

Vk_20220311_02

16.03.2022

GE Medical Systems LLC

Signa 1.5T TwinSpeed, Signa 1.5T Excite HD, 1.5T Signa HDx, 1.5T Signa HDxt, 1.5T Signa HDxt mobile

Signa 3.0T Excite HD, Signa Excite 3T, 3.0T Signa HDx, 3.0T Signa HDxt

MD: Full-body MRI system, superconducting magnet

IVD: Full-body MRI system, superconducting magnet

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

Vk_20220309_03

08.03.2022

(Updated 16.03.2022)

Abbott Molecular Inc.

Alinity m HBV AMP Kit
Model: 08N47-090; (US and Hong Kong only: 08N47-095)
Lot: Not Lot specific

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

DE-1
FR-1
EN-1

Vk_20220308_02

22.02.2022

(Updated 16.03.2022)

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
FR-1
IT-1
EN-1

Vk_20220217_70

14.03.2022

(Updated 15.03.2022)

FIAB SpA

Pads for Defibrillation “Bexen Cardio”
Model: KSA 0501D
Lot: 19DF1690, 19DF1846, 19DF2085, 20DF0160, 20DF0854, 20DF1178, 20DF1738, 20DF1958, 20DF2507, 21DF0039, 21DF0858, 21DF1450, 21DF1711, 21DF2025

MD: Defibrillator electrode, external, single-use

DE-2
FR-2
EN-3

Vk_20220311_30

15.03.2022

Philips Medical Systems Nederland BV

Philips Hemodynamic System
Model: 722463
SW-Version: R1.2.2, R1.2.3

MD: Haemodynamic monitoring system application software

DE-1
FR-1
IT-1

Vk_20220309_27

09.03.2022

(Updated 14.03.2022)

Siemens Healthcare Diagnostics Inc

Atellica IM/ADVIA Centaur Enhanced Estradiol (eE2)
Model: 10995561, 10995562, 10490889, 10491445
Lot: All Lots

IVD: Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
EN-1

Vk_20220307_13

08.03.2022

(Updated 14.03.2022)

Mikrogen GmbH

recomScan Software
Model: 31006, 31013
SW-Version: 3.4

IVD: software for avidity test systems

DE-1
EN-1

Vk_20220304_21

01.03.2022

(Updated 14.03.2022)

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
FR-1
IT-1
EN-1

Vk_20220301_01

11.03.2022

B. Braun Melsungen AG

Vasofix Safety, Vasofix Certo
Model: 4269071S-01, 4269071
Lot: See FSN

MD: Peripheral vascular infusion catheter

DE-1
FR-1
IT-1

Vk_20220308_17

11.03.2022

Corin Medical Ltd.

Trinity Acetabular Hip System
Model: 921.109; Not applicable
Lot: 87765, 26626, 83897, 25250, 24097, 80688, 23185, 22593, 77157, 75953, 20751, 69875, 69253, 17162, 22416, 68747, BL69809-13, BL69956-14, 64227, 63690, BL68271-13, 63215, 62073, 59388, 59387, 59346, 59229, 58396, 58141, 58204, 57391, 57559, 56454, 54825, 54
S/N: Not applicable

MD: Surgical depth gauge, reusable

DE-1
EN-1

Vk_20220223_06

08.03.2022

(Updated 09.03.2022)

Philips Medical Systems

Adult SMART Pad
Model: M5071A

Infant/Child SMART Pad
Model: M5072A

MD: External defibrillator electrode, adult, single-use

MD: External defibrillator electrode, paediatric, single-use

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

Vk_20220303_16

09.03.2022

Siemens Healthcare GmbH

syngo.via RT Image Suite
Model: 11546118
S/N: Siemens CT and syngo.via-Servers running the software syngo.via RT Image Suite, upgraded from earlier versions to VB60, are affected.

MD: CT system application software

DE-1

Vk_20220301_19

02.03.2022

(Updated 09.03.2022)

Siemens Healthcare Diagnostics Inc

Atellica 1500 Automated Urinalysis System
Model: SMN 11065004
S/N: All
SW-Version: All versions

Atellica UAS 800 Analyzer
Model: SMN 11065004
S/N: All
SW-Version: All versions

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

DE-1
FR-1
EN-1

Vk_20220225_20

08.03.2022

Intuitive Surgical, Inc

Endowrist Vessel Sealer Extend; SynchroSeal
Model: 480422; 480440

MD: Robotic electrosurgical instrument, bipolar, single-use

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

Vk_20220308_12

08.03.2022

Schiller AG

FRED easyport plus
Model: 3.940060, 3.940066, 3.940063; 0A.900000
S/N: see FSN
SW-Version: all versions before 1.2.2

MD: Non-rechargeable professional semi-automated external defibrillator

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

Vk_20220304_15

08.03.2022

RaySearch Laboratories AB (publ)

RayStation
Model: RayStation 11A, RayStation 11B, RayTreat 5A, RayTreat 5B including some service packs
SW-Version: 11.0.0.951, 11.0.1.29, 11.0.3.116, 12.0.0.932

MD: Radiation therapy software

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

Vk_20220304_06

08.03.2022

Boston Scientific Corporation

EXALT Model D Single-Use Duodenoscope
Model: M00542420, M00542421, M0054242CE0, M0054242CE1
Lot: All
SW-Version: N/A

MD: Flexible video duodenoscope, single-use

DE-1
EN-1

Vk_20220303_27

08.03.2022

SENTINEL CH SpA

CALiaGold Control Set
Model: 1151200
Lot: 10948, 11025, 11165

IVD: Calprotectin IVD, control

EN-1

Vk_20220303_19

07.03.2022

Siemens Healthcare GmbH, HC SV DS,

Artis zee

Artis Q

Artis Q.zen

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1
IT-1

Vk_20220224_16

22.02.2022

(Updated 07.03.2022)

Hill-Rom, Inc.

Compella Bariatric Bed and Controller
Model: P7800 P7810
S/N: Q061CB0021 to W355CB4154

MD: Bariatric Bed

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

Vk_20220222_01

22.02.2022

(Updated 07.03.2022)

Bode Chemie GmbH

Dismozon plus
Model: 981187 / 981257

MD: Medical device disinfection agent

DE-1
FR-1
IT-1

Vk_20220221_06

04.03.2022

Fuhrmann GmbH

Positioning Aids
Model: 300000, 300300
Lot: 30136796, 30136748, 30137046, 30137161, 30137292, 30137362, 30137866

MD: Positioning Aids

DE-1
EN-1

Vk_20220223_16

01.03.2022

(Updated 04.03.2022)

ImplanTec GmbH

ANA.NOVA Alpha Schaft
Model: All
Lot: All

MD: Prosthesis, joint, hip, femoral component

DE-1
FR-1
EN-1

Vk_20220222_10

02.03.2022

Boston Scientific Corporation

SpaceOAR and SpaceOAR Vue Systems
Model: SO-1010; SV-1010
Lot: All
S/N: All

MD: Radiotherapy protection spacer

DE-1
FR-1
EN-1

Vk_20220224_19

02.03.2022

Siemens Healthcare Diagnostics Products Limited

IMMULITE 2000 HCG
Model: L2KCG2, L2KCG6
Lot: All lots
S/N: N/A
SW-Version: N/A

IVD: Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay

FR-1
EN-1

Vk_20220224_15

24.02.2022

(Updated 02.03.2022)

Cipher Surgical Ltd

OpClear Disposable Procedure Kit
Model: CS-SZ10-00, CS-SZ10-30, CS-SR10-00, CS-SR10-30
Lot: A26/2/0041/21Y, A25/2/0041/21Z, A28/2/0041/21W, A27/2/0041/21X

MD: Endoscope lens cleaner, gas/fluid, single-use

DE-1
EN-1

Vk_20220218_26

02.03.2022

Siemens AG Healthcare

syngo Application Sotfware
Model: Artis pheno, Artis icono biplane, Artis icono floor
SW-Version: VE20

MD: Basic diagnostic x-ray system application software

DE-1
FR-1
EN-1

Vk_20220215_28

01.03.2022

Meridian Bioscience, Inc.

Revogene
Model: 610210, 130840
S/N: All

IVD: Integrated systems for nucleic acid extraction/amplification/detection

EN-1

Vk_20220224_20

01.03.2022

Liko AB

UNIVERSAL TWINBAR 670
Model: 3156087, P3156087, Liko M230 – model 2050015 (serial number 5361393-5362761)

MD: Overhead track patient lifting/transfer system

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

Vk_20220223_02

01.03.2022

Illumina, Inc

NextSeq 550Dx
Model: 20005715
S/N: NDX550427 and below

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

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

Vk_20220222_09

18.02.2022

(Updated 01.03.2022)

NeuMoDx Molecular, a QIAGEN Company

NeuMoDx Cartridge
Model: 100100
Lot: 115424, 115425, 115426, 115427, 115429, 115431
S/N: N/A

IVD: Microplate IVD

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

Vk_20220217_57

28.02.2022

(Updated 01.03.2022)

Siemens AG Healthcare

ARTIS icono / pheno

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20220215_30

17.02.2022

(Updated 01.03.2022)

Maquet Critical Care AB

Servo-u
Model: 6694800

Servo-n
Model: 6688600

MD: General-purpose intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

DE-1
FR-1
EN-1

Vk_20220210_13

15.02.2022

(Updated 01.03.2022)

Philips Medical Systems

Esophageal/Rectal Temperature Probes
Model: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641

MD: General-purpose patient temperature probe, reusable

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

Vk_20220209_02

09.02.2022

(Updated 01.03.2022)

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
EN-1

Vk_20220203_28

01.03.2022

Welch Allyn Inc.

Q-Stress / XScribe, HScribe / Vision Express, RScribe, DCS / Connex Cardio
SW-Version: See FSN

MD: Electrocardiographic long-term ambulatory recording analyser application software

DE-1
FR-1
IT-1

Vk_20220110_07

01.03.2022

HYPHEN BioMed SAS

HEMOCLOT Quanti. V-L
Model: CK065K
Lot: FA091617

IVD: Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting

EN-1

Vk_20211227_13

03.12.2021

(Updated 01.03.2022)

Maquet Critical Care AB

Flow-i C30
Model: 6888530

Flow-i C20
Model: 6888520

Flow-i C40
Model: 6888540

Flow-c
Model: 6887700

Flow-e
Model: 6887900

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

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

Vk_20211126_01

22.02.2022

(Updated 24.02.2022)

Deerfield Imaging, inc

HFD100 – ORT400 Imperial
Model: 118704-000 (component), 119629-000 (HFD100 top level)
S/N: Mount Clamp (118704-000): 10007558, 10008865, 10010675

MD: Skull clamp

FR-1
EN-1

Vk_20220221_16

22.02.2022

(Updated 24.02.2022)

Abbott Molecular Inc.

Integrated Reaction Unit (IRU)
Model: 09N26-010
Lot: 766233, 770433, 771200, 771201, 773642

IVD: General laboratory assay tray

DE-1
FR-1
EN-1

Vk_20220215_26

14.12.2021

(Updated 24.02.2022)

Abbott Molecular Inc.

Alinity m System
Model: 08N53-002
S/N: All instruments

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

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

Vk_20211208_03

22.02.2022

(Updated 23.02.2022)

NISSHA MEDICAL TECHNOLOGIES SAS

Clarevue PM
Model: 50401, 50500, 50502, 50507, 50600, 50601, 50602, 50603, 50604

MD: Ecg Electrodes

DE-1
FR-1
EN-1

Vk_20220215_27

22.02.2022

SEBIA

CAPI 3 IMMUNOTYPING
Model: 2600
Lot: 18111/01

IVD: Multiple clinical chemistry protein IVD, reagent

DE-1
FR-1

Vk_20220216_13

22.02.2022

Siemens Healthcare Diagnostics Inc.

Calcium_2 (CA_2) reagents
Model: 11097644
Lot: All lots

Enzymatic Hemoglobin A1c (A1c_E) reagents
Model: 11097536
Lot: All lots

Fructosamine (Fruc) reagents
Model: 11097637
Lot: All lots

Lithium_2 (LITH_2) reagents Calcium_2 (CA_2) reagents Fructosamine (Fruc) reagents
Model: 11532401
Lot: All lots

IVD: Calcium (Ca2+) IVD, kit, spectrophotometry

IVD: Glycated haemoglobin (HbA1c) IVD, kit, enzyme spectrophotometry

IVD: Fructosamine IVD, kit, enzyme spectrophotometry

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

DE-1
FR-1

Vk_20220210_18

21.02.2022

Instrumentation Laboratory Co.

HemosIL AcuStar ADAMTS 13
Model: 0009802048
Lot: B33919, B33919, B834173, B34353, B834520

IVD: Special Coagulation Tests

DE-1
EN-1

Vk_20220211_33

08.02.2022

(Updated 21.02.2022)

DiaSys Diagnostic Systems GmbH

oneHbA1c IS
Model: 1 3329 99 10 760
Lot: Lot: 03 101 26, Kit Lot: 60148641
S/N: N/A

IVD: Glycosylated/Glycated Haemoglobin

FR-1
EN-1

Vk_20220203_26

02.02.2022

(Updated 21.02.2022)

Getinge Disinfection AB

ED-FLOW, ED-FLOW SD
Model: ED-FLOW, ED-FLOW SD
S/N: All ED-Flows manufactured since start 2010 until 2021-10-20

MD: Endoscope washer/disinfector

DE-1
DE-2
EN-1

Vk_20220131_12

08.09.2021

(Updated 21.02.2022)

Smiths Medical ASD, Inc.

Level 1 NORMOFLO Irrigation Fluid Warmer
Model: H-1100, H-1129
Lot: All
S/N: All
SW-Version: N/A

Level 1 Fluid Warmer
Model: H-1025, H-1028, H-1200
Lot: All

Level 1 Fast Flow Fluid Warmer
Model: H-1000, H-500
Lot: All

Level 1 NORMOFLO Irrigation Fluid Warming Set
Model: IR-40, IR-500, IR-600, IR-700, IRI-600, IRI-600B
Lot: All

Level 1 Normothermic I.V. Fluid Administration Set
Model: D-100, D-300, D-50, D-60HL, DI-100, DI-300, DI-50, DI-60HL, D-70, DI-70
Lot: All

H-2 Level 1 – Pressure Chamber
Model: 7204012, 7204016, 7204017, 7204018, 7204019, 7204020, 7204030, 7204031, 7204034, 7204036, 7204037, 7204068, 7204066, 7204074
Lot: All

Level 1 – High-Flow 3 Way Stopcock
Model: SC-3
Lot: All

Level 1 – High Flow Extension Line
Model: X-36
Lot: All

Level 1 – High Flow Extension with Injection Site
Model: Y-INJ
Lot: All

Level 1 – High Flow Y-Type Extension
Model: Y-30
Lot: All

Level 1 – Gas Vent/Filter Assembly Replacement
Model: F-10, F-30
Lot: All

Level 1 – Patient Line Sets
Model: PL-6, PL-7
Lot: All

MD: Convection blood/fluid warmer, high-flow

MD: Convection blood/fluid warmer, high-flow

MD: Convection blood/fluid warmer, high-flow

MD: Heat-exchanging intravenous administration set

MD: Heat-exchanging intravenous administration set

MD: Intravenous pressure infusor, automated

MD: Intravenous line stopcock

MD: Intravenous administration tubing extension set

MD: Intravenous administration tubing extension set

MD: Intravenous administration tubing extension set

MD: Intravenous line filter

MD: Heat-exchanging intravenous administration set

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-0
EN-1
EN-2

Vk_20210816_02

23.08.2021

(Updated 21.02.2022)

Immunotech S.A.S.

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

IVD: Troponin I IVD, kit, chemiluminescent immunoassay

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

Vk_20210809_09

18.02.2022

bioMérieux SA

VIDAS CMV IgM
Model: 30205 / 30205-01
Lot: 1008873250 – Expiry Date 01JUN2022, 1008873260 – Expiry Date 01JUN2022, 1008988860 – Expiry Date 27JUL2022, 1009095380 – Expiry Date 27SEP2022

IVD: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1

Vk_20220210_14

18.02.2022

CooperVision Manufacturing Limited

Hy-Care and all branded variants of Hy-Care
Model: CLC005

MD: Multi-purpose soft/rigid contact lens solution

DE-1
FR-1
IT-1

Vk_20220209_15

15.02.2022

(Updated 17.02.2022)

astraia software GmbH

astraia software for women’s health
SW-Version: 1.27.0 or higher

MD: Patient health record information system

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

Vk_20220211_06

17.02.2022

Philips Medical Systems Nederland BV

Philips Azurion 7 M20
Model: 722079
SW-Version: Philips Azurion R2.0.x

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

DE-1
FR-1
EN-1

Vk_20220210_20

17.02.2022

Siemens AG Medizinische Technik – AX

Ysio
Model: 10281013

MD: Stationary basic diagnostic x-ray system, digital

DE-1
FR-1

Vk_20220210_15

17.02.2022

Biocon MedizintechnikGmbH

Sterile Surgical Gowns

MD: Surgical gown, single-use

DE-1

Vk_20220209_01

16.02.2022

B. Braun Melsungen AG

INF.SP.LINE, TRANS, PVC, LL, 250CM-EU
Model: 8270066SP-01
Lot: 21F23E8ST5, 21F25E8ST5, 21G16E8ST5, 21G17E8ST5

MD: Electric infusion pump administration set, single-use

DE-1

Vk_20220210_02

15.02.2022

Synedra Information Technologies GmbH

synedra View
Model: Teilmodul von synedra AIM
SW-Version: 19.x (Zephyr), 20.0.0.x (Kassiopeia)

MD: Radiology picture archiving and communication system

DE-1
FR-1
EN-1

Vk_20220211_18

15.02.2022

Suricog

EyeBrain
Model: T2
S/N: 0004-01-1308

MD: Eye-tracking neurological/brain injury assessment device

FR-2
EN-1

Vk_20220210_03

15.02.2022

BHS Technologies GmbH

RoboticScope
Model: BHS1100, 12075

MD: Microscope, operating

DE-1

Vk_20220203_01

15.02.2022

HeartWare Inc.

HeartWare Ventricular Assist System (HVAD)
Model: Controller AC Adapter: 1425, 1430; Controller DC Adapter: 1440; Battery: 1650DE

AIMD: Implantable ventricular circulatory assist system

DE-1
EN-1

Vk_20220202_01

11.02.2022

Philips Goldway (Shenzhen) Industrial Inc.

HeartStart Intrepid Monitor/Defibrillator
Model: 867172

MD: Rechargeable professional automated external defibrillator

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

Vk_20220211_11

01.02.2022

(Updated 11.02.2022)

Acandis GmbH & Co. KG

DERIVO 2 Embolisation Device
Model: 01-107001; 01-107002; 01-107003; 01-107004; 01-107005; 01-107006; 01-107007; 01-107008; 01-107009; 01-107010; 01-107011; 01-107012; 01-107039; 01-107043; 01-107047; 01-107048; 01-107052; 01-107053; 01-107057; 01-107058
Lot: all

MD: Bare-metal intracranial vascular stent

DE-1
EN-1

Vk_20220125_17

10.02.2022

BIP Biomedizinische Instrumente und Produkte GmbH

BIP O-Twist-Marker SRX
Model: OTM-SRX; OTM3.0SRX
Lot: 0919, 0220, 0920, 1220, 0121, 0221, 0321, 0421, 0721, 0821

MD: Imaging lesion localization marker, implantable

DE-1
FR-1
EN-1

Vk_20220204_01

10.02.2022

ConvaTec Limited

Urostomy Pouches – Combihesive and Natura

MD: Multiple-piece urostomy bag, open-ended

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

Vk_20220131_13

13.05.2020

(Updated 10.02.2022)

Radiometer Medical ApS

ABL800
Model: 393-800, 393-801
S/N: All
SW-Version: 6.19 and below

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

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

Vk_20200506_19

09.02.2022

arcomed ag

Volumed µVP7000
Model: Chroma; 7T-XRP-01, 7X-UOS-01
S/N: 71007674, 71007676, 71007677, 71007680, 71007698, 71007708, 71007737, 71007755, 71036429, 71036435, 71036772, 71036814, 71036841, 71046180, 71046856

MD: Infusion Pumps, Multitherapy, Ambulatory

DE-1
FR-1

Vk_20220209_07

09.02.2022

Philips Medical Systems Nederland BV

Philips StentBoost Live
Model: 459801781661, 722079, 722136, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228; NA
SW-Version: StenBoost Live R2.0 with Azurion R2.x

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

DE-1
EN-1

Vk_20220204_22

09.02.2022

GE Healthcare Tianjin Company Limited and GE Medical Systems LLC

Signa MR/i MR System
Model: See FSN

Brivo MRI System
Model: See FSN

Discovery MRI System
Model: See FSN

EchoSpeed MRI System
Model: See FSN

HighSpeed Plus MRI System
Model: See FSN

MR Max MRI System
Model: See FSN

MR Vectra MRI System
Model: See FSN

Optima MRI System
Model: See FSN

OrthOne MRI System
Model: See FSN

MSK Extreme MRI System

SmartSpeed MRI System

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

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: MRI system, superconducting magnet

MD: MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

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

Vk_20220204_17

08.02.2022

Drägerwerk AG & Co. KGaA

Evita V300
Lot: all
SW-Version: 2.60 and older

Evita Infinity V500
Lot: all
SW-Version: 2.60 and older

Babylog VN500
Lot: all
SW-Version: 2.60 and older

MD: Neonatal/adult intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

DE-1
FR-1
IT-1

Vk_20220204_21

03.02.2022

(Updated 08.02.2022)

Sysmex Corporation Japan

FLUOROCELL PLT
Model: CD-994-563
Lot: A1003, A1004, A1006

IVD: CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids)

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

Vk_20220203_08

08.02.2022

Huntleigh Healthcare

Dopplex
Model: DIOP8
Lot: 107842006001

MD: Invasive/noninvasive vascular ultrasound probe

EN-1

Vk_20220202_16

08.02.2022

Siemens Medical Solutions USA, Inc., Ultrasound

ACUSON Juniper Diagnostic Ultrasound System
Model: 11361954
S/N: See consignee list.
SW-Version: VA10D, VA10E, VA10F

MD: General-purpose ultrasound imaging system

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

Vk_20220128_16

08.02.2022

W.O.M. World of Medicine GmbH

HysteroLux Fluid Management System
Model: PH304
Lot: 72205000

MD: Hysteroscopic irrigation/insufflation system

DE-1
EN-1

Vk_20220126_10

01.02.2022

(Updated 07.02.2022)

Biomerieux

VIDAS High Sensitive Troponin I
Model: 415386, 415386-30

IVD: Troponin I IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20220127_14

02.12.2020

(Updated 04.02.2022)

Roche Molecular Systems Inc.

cobas z 480 analyzer
Model: 05200881001

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

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

Vk_20201124_09

01.02.2022

Össur hf

RESOLVE HALO
Model: see FSN
Lot: All Lot numbers
S/N: N/A

MD: Cervical spine immobilization system, single-use

DE-1
FR-1
IT-1

Vk_20220131_28

01.02.2022

SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.

Inflation Device
Model: 459831-1
Lot: SKI21W12

MD: Inflation device

DE-1
FR-1
EN-1

Vk_20220131_14

01.02.2022

MicroVention Inc.

HydroSoft 3D

MD: Neurovascular embolization coil

DE-1
FR-1
IT-1

Vk_20220126_08

13.10.2021

(Updated 01.02.2022)

Siemens Healthcare GmbH

Sensis, Sensis Vibe Combo, Sensis Vibe Hemo
Model: 10764561, 11007642, 11007641
SW-Version: VD1X

MD: Cardiac catheterization laboratory computer

DE-1
FR-1
IT-1

Vk_20211005_09

27.01.2022

Medtronic MiniMed

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

MiniMed 670G Insulin Pump
Model: MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1741, MMT-1742
S/N: all

MiniMed 720G Insulin Pump
Model: MMT-1809, MMT-1810, MMT-1859, MMT-1860
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-1881, MMT-1882, MMT-1892, MMT-1891
S/N: all

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

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

MD: Ambulatory insulin infusion pump, electronic

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

Vk_20220127_09

19.01.2022

(Updated 27.01.2022)

Ventana Medical Systems Inc

BENCHMARK ULTRA STAINER MODULE
Model: 05342716001
S/N: all
SW-Version: N/A

IVD: Microscope slide stainer IVD

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

Vk_20220114_19

19.01.2022

(Updated 27.01.2022)

SD BIOSENSOR, INC.

Standard Q COVID-19 IgM/IgG Combo Test
Model: Q-NCOV-01C; 09COV50G

IVD: Other Other Virology – RT & POC

FR-1
EN-1

Vk_20220114_12

25.01.2022

Chromsystems Instruments & Chemicals GmbH

Analytical column, MassChrom Free Metanephrines
Model: 81100; 81100
Lot: 3819, 0720, 1520, 2920, 0221, 0521, 1121, 2121
S/N: n/a
SW-Version: n/a

IVD: High performance liquid chromatography analyser column IVD

DE-1
FR-1
IT-1

Vk_20220121_09

25.01.2022

Baxter Healthcare SA

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

Minicap Extd Life Transfer Set
Model: R5C4484
Lot: All lots within expiry

MD: Peritoneal dialysis system tubing set

MD: Peritoneal dialysis system tubing set

DE-1
FR-1
IT-1

Vk_20220118_08

24.01.2022

Newdeal SAS

TIBIAXYS Hexalobular T10 Screwdriver
Model: 219135ND
Lot: FTL9, FTLA and FVRG

MD: Surgical screwdriver, reusable

DE-1
EN-1

Vk_20220112_08

18.01.2022

(Updated 21.01.2022)

OSCOR Inc.

Guidestar Steerable Guiding Sheath
Model: D141103
Lot: See FSN
S/N: N/A

Destino Twist Steerable Guiding Sheath
Model: DST1405525
Lot: See FSN
S/N: N/A

MD: Vascular guide-catheter, single-use

MD: Vascular guide-catheter, single-use

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

Vk_20220114_15

20.01.2022

Armstrong Medical Limited

AquaVENT FD140i Gas Flow Driver

MD: CPAP unit

DE-1
EN-1

Vk_20220114_23

20.01.2022

B. Braun Melsungen AG

B. Braun Perfusor Space
Model: 8713030
S/N: 632251, 632274, 632283, 632284, 632289, 632295, 632314, 640165

MD: Syringe pump

DE-1

Vk_20220112_11

12.01.2022

(Updated 20.01.2022)

Implantcast GmbH

AGILON glenoid components
Model: 38004001, 38004009, 38004010, 38004028, 38004029, 38004075, 38004071, 38004072, 38004073, 38004074
S/N: All manufactured parts placed on the market since 2017 until 12/31/2021

MD: Reverse shoulder prosthesis base plate

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

Vk_20220107_12

19.01.2022

NRT-Nordisk Røntgen Teknik A/S

Celex and Intelli-C EU
Model: See FSN
S/N: Device SN: 658008; Affected Footrest SN: 903282000046

MD: Stationary angiographic x-ray system, digital

DE-1
EN-1

Vk_20220113_02

19.01.2022

Medtronic Inc.

Prevail Paclitaxel-coated PTCA Balloon Catheter
Model: PRV025020RX, PRV025030RX, PRV035015RX, PRV035020RX, PRV035025RX
Lot: 0010853342, 0010841909, 0010837068, 0010837067, 0010765701, 0010832009, 0010815239

MD: Coronary angioplasty balloon catheter, drug-coated

FR-1

Vk_202

24.09.2021

(Updated 19.01.2022)

Cook Incorporated

Vascular Retrieval Forceps
Model: VRF-3.0-120
Lot: NS14325027

Kwart Retro-Inject Ureteral Stent Set
Model: 003500
Lot: NS13712097

Dotter Intravascular Retriever Set
Model: DRS-100
Lot: 10266860, 13296938

Miller Double Mushroom Biliary Stent Set
Model: UBSS-10-7.5-MLR
Lot: 9984121X

MD: Intravascular extraction catheter-snare

MD: Polymeric ureteral stent

MD: Intravascular extraction catheter-snare

MD: Biliary drain

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

Vk_20210922_12

19.10.2021

(Updated 18.01.2022)

Medtronic Inc.

Percept PC BrainSense
Model: B35200
S/N: All

AIMD: Deep brain electrical stimulation system

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

Vk_20211013_07

13.01.2022

(Updated 17.01.2022)

HS Doms GmbH

Centric
Lot: HD02480
S/N: HD02480

MD: Chairs, Examination/Treatment, Ophthalmology

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

Vk_20211229_10

13.01.2022

(Updated 17.01.2022)

HS Doms GmbH

HS-2010
S/N: HD02465, HD02466, HD02467

MD: Examination/Treatment Stands, Ophthalmic

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

Vk_20211229_09

17.01.2022

Medtronic Inc.

Endurant II/IIs Stent Graft System
Model: see FSN
S/N: see FSN

MD: Abdominal aorta endovascular stent-graft

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

Vk_20211223_02

21.12.2021

(Updated 14.01.2022)

Liko AB

Liko M230
Model: Model 2050015
S/N: 5361393-5362761

Liko M220
Model: Model 2050010
S/N: 5361393-5362761

MD: Mobile patient lifting system, battery-powered

MD: Mobile patient lifting system, battery-powered

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

Vk_20211216_20

13.01.2022

Applied Medical Resources Corporation

Epix Reusable Probe, 5mm x 45cm
Model: C7211; 101260801
Lot: 1413028; 1418704; 1427261

MD: Suction cannula, reusable

FR-1
EN-1

Vk_20220111_28

12.01.2022

Bühlmann Laboratories AG

Quantum Blue Anti-Infliximab
Model: LF-ADIF25; LF-ADIF10
Lot: 1107.N.S; 1107.N

IVD: TNF-alpha inhibitor antibody IVD, kit, immunochromatographic test (ICT), rapid

DE-1
EN-1

Vk_20220107_02

12.01.2022

Thermo Fisher Scientific – Microbiology Central Reporting

Cefiderocol on Sensititre plates
Model: T3462
Lot: 267261 to 402775

IVD: Reagent

FR-1
EN-1

Vk_20220106_06

12.01.2022

OxyPrem AG c/o Universität Zürich Klinik für Neonatologie

OxyPrem 1.4
Model: 001
Lot: All
S/N: All

MD: UMDNS=17-942

DE-1
FR-1
EN-1

Vk_20211227_12

21.12.2021

(Updated 12.01.2022)

Ambu A/S

AMBU SPUR II
Model: 32502300, , 32502300, 330023000, 325000530
Lot: 1000000280 to 1000212707 etc.

MD: Pulmonary resuscitator, manual, single-use

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

Vk_20211214_15

21.12.2021

(Updated 10.01.2022)

Medtronic Xomed

NIM TriVantage EMG Endotracheal Tube
Model: 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739; –
Lot: –
S/N: all

MD: Basic endotracheal tube, single-use

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

Vk_20211216_15

28.12.2021

(Updated 07.01.2022)

bioMérieux SA

ID 32 C
Model: 32200
Lot: 1008781060
SW-Version: N/A

IVD: Multiple Candida/yeast species culture isolate identification IVD, kit

DE-1
FR-1
EN-1

Vk_20211223_31

28.12.2021

(Updated 06.01.2022)

Laerdal Medical AS

Laerdal Suction Unit with Reusable Canister
Model: 784000, 78000000, 78000003, 78000033
Lot: 1721 – 2621
S/N: see FSN

MD: Emergency airway clearance suction system, electric

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

Vk_20211221_31

23.12.2021

(Updated 06.01.2022)

Synthes GmbH

Universal Chuck
Model: 03.043.001
Lot: 20911101, 20229201, 21210202, 21781103
S/N: N/A
SW-Version: N/A

MD: Surgical drill chuck

DE-1
EN-1

Vk_20211220_05

14.12.2021

(Updated 06.01.2022)

EUROS FRANCE

NEMOST – Growing Domino
Model: A304013051; A304013081
Lot: all

MD: Bone-screw internal spinal fixation system, sterile

DE-1
FR-1
EN-1

Vk_20211214_02

05.01.2022

Intuitive Surgical, Inc

Reducer, IS4000, 12-8MM, Disposable, Box of 6
Model: 470381-11
Lot: see FSN

MD: Laparoscopic access cannula seal reducer

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

Vk_20220103_27

24.11.2021

(Updated 03.01.2022)

Siemens Medical Solutions USA, Inc., Ultrasound

ACUSON Sequoia
Model: 11148775
SW-Version: Sequoia 1.2 (VA25A/VA25B)

MD: General-purpose ultrasound imaging system

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

Vk_20211122_23