Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.11.2020 – 31.12.2020

Опубліковано 04.01.2021 о 15:29

https://fsca.swissmedic.ch/mep/#/

15.12.2020 

(Updated 11.01.2021)

Carl Zeiss Meditec AG

IOLMaster 700
Model: 000000-1932-169
S/N: 1154757
SW-Version: 1.90.2.09 and 1.90.8.06

MD: Optical low coherence reflectometry (OLCR) biometer

IT-1
EN-1

Vk_20201208_19

09.12.2020 

(Updated 11.01.2021)

Siemens Healthcare Diagnostics Inc

Atellica IM 1300
SW-Version: V1.23.2 and prior

Atellica CH 930 Analyzer
SW-Version: V1.23.2 and prior

Atellica IM 1600
SW-Version: V1.23.2 and prior

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

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

Vk_20201207_15

29.09.2020 

(Updated 11.01.2021)

Siemens Healthcare Diagnostics Inc

ADVIA Centaur HBsAgII
Model: 10492138
Lot: see FSN
S/N: N/A

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

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

Vk_20200925_10

05.02.2020 

(Updated 11.01.2021)

Siemens Healthcare Diagnostics Inc.

Atellica CH 930 Reaction Cuvette Segment
Model: SMN 11099326
Lot: see FSN
S/N: N/A

IVD: Laboratory analyser cuvette IVD, reusable

DE-1
DE-2
DE-3
DE-5
FR-5
EN-1
EN-2
EN-3
EN-4
EN-5

Vk_20200128_08

30.12.2020 

(Updated 08.01.2021)

Qiagen GmbH

QIAstat-Dx Respiratory SARS-CoV-2 Panel
Model: 691214
Lot: 200218
S/N: 402180003 to 402180299

IVD: Other Nucleic Acid Identification – automated

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

Vk_20201230_01

24.12.2020 

(Updated 08.01.2021)

Liko AB

Multirall 200
Model: 3130001
S/N: see FSN

MD: Stationary patient lifting system, line-powered

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

Vk_20201215_16

22.12.2020 

(Updated 08.01.2021)

BD

BD 1ml Syringe Luer-Lok
Model: 309628

BD Plastipak 1ml Luer
Model: 303172

BD Blunt Fill Needle with Filter 18G x 1 1/2
Model: 305211

BD Microlance 3 30G x 1/2 0,3 x 13mm
Model: 302809; 304000

MD: General-purpose syringe, single-use

MD: Imaging lesion localization marker, external, reusable

MD: Medication transfer needle, filtering

MD: Hypodermic needle, single-use

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

Vk_20201209_19

27.03.2017 

(Updated 08.01.2021)

Stryker Instruments

SmartLife Large Aseptic Housing
Model: 7126-120-000
Lot: Not lot number related

MD: Rechargeable battery pack

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

Vk_20170320_02

07.01.2021

WRP Asia Pacific

Dermagrip Ellbogen-Handschuh
Model: small size; D3965-15
Lot: 60301149

MD: Hevea-latex surgical glove, non-powdered, non-antimicrobial

DE-1
FR-1
IT-1

Vk_20210105_08

07.01.2021

GE Medical Systems Israel, Functional Imaging

Discovery NM 630, Optima NM/CT 640, Discovery NM/CT 670 DR, Discovery NM/CT 670 Pro, Discovery NM/CT 670ES, NM 830, NM 830 DoD, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR

MD: Stationary gamma camera system

EN-1

Vk_20210104_20

07.01.2021

Invacare Corporation

Invacare Perfecto2 V Oxygen Concentrator
Model: IRC5PO2VAW
S/N: 17HF030338-18IF018523

MD: Mobile/portable oxygen concentrator

EN-1

Vk_20201229_11

29.12.2020 

(Updated 07.01.2021)

DePuy Ireland

PINNACLE 100 ACET CUP
Model: 121701048, 121701050, 121701052, 121701054, 121701056, 121701058, 121701060, 121701062
Lot: all

PINNACLE 100 HA ACET CUP
Model: 121711048, 121711050, 121711052, 121711054, 121711056
Lot: all

PINN SECTOR HA ACET CUP
Model: 121712048, 121712050, 121712052, 121712054, 121712056
Lot: all

PINN SECTOR ACET CUP
Model: 121722048, 121722050, 121722052, 121722054, 121722056, 121722058, 12172204860, 121722062
Lot: all

PINN 100 W/GRIPTION
Model: 121731048, 121731050, 121731052, 121731054, 121731056, 121731058, 121731060, 121731062
Lot: all

PINN SECTOR W/GRIPTION
Model: 121732048, 121732050, 121732052, 121732054, 121732056, 121732058,121732060, 121732062, 121732064
Lot: all

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

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

Vk_20201223_11

30.12.2020 

(Updated 07.01.2021)

Mölnlycke Health Care AB

Mölnlycke Procedure Trays and Single Packed Trocars
Model: see FSN
Lot: see FSN

MD: trocars single packed and in procedure trays

DE-1
FR-1
EN-1

Vk_20201222_22

24.02.2020 

(Updated 06.01.2021)

Siemens Healthcare Diagnostics Products Limited

IMMULITE/IMMULITE 1000 Estradiol
Model: LKE21
Lot: all lots

IMMULITE 2000/IMMULITE 2000 XPi Estradiol
Model: L2KE22, L2KE26
Lot: all lots

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

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

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

Vk_20200212_13

23.12.2020 

(Updated 05.01.2021)

DiaMed GmbH

ID-DiaCell; ID-Dia Screen; ID-Dia Panel
Model: see FSN
Lot: All lot currently in date

IVD: reagent red blood cell

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

Vk_20201217_09

17.12.2020 

(Updated 05.01.2021)

Bemer Int. AG

BEMER Classic und Pro Set
Model: Art.-Nr. 410200, Art.-Nr.420200, Art.-Nr. 410100, Art.-Nr.420100
Lot: Nicht relevant
S/N: all
SW-Version: Nicht relevant

MD: Produkt zur physikalische Gefaesstherapie

DE-1
FR-1
IT-1

Vk_20201211_16

28.12.2020 

(Updated 04.01.2021)

Accuray Incorporated (Madison)

TomoTherapy Treatment System
S/N: See FSN
SW-Version: 1.2.0 & 5.1.5

MD: Linear accelerator system

FR-1
EN-1

Vk_20201221_10

22.12.2020 

(Updated 04.01.2021)

Argon Medical Devices Inc.

TLAB Transjugular Liver Biopsy System
Model: TL-18C, TL-18N, TL-18S, TL-19, TL-19N, TL-19S
Lot: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182, 1419198, 1467762, 1473975, 1502312, 1419196, 1460291, 1469844, 1502325, 1428364, 1451428, 1486448, 1439836, 1451430, 1486441, 1439835, 1451429, 1486445

MD: Soft-tissue biopsy needle, single-use

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

Vk_20201221_05

04.01.2021

Medisafe UK Limited

Distal Duck Kit
Model: M20350, M20358, M20359, and M20400;N/A
Lot: 1811273 1906484 1909644 2001718, 1811277 1906499 1910649 2001719, 1811278 1906508 1910651 2001730, 1901340 1906529 1910653 2004766, 1901349 1907556 1911658 2004768, 1902374 1907571 1911680 2004770, 1903408 1908593 1911691 2004772, 190
S/N: N/A

MD: Medical device cleaning agent

DE-CUST_1
DE-DIST_1
FR-CUST_1
FR-DIST_1
IT-CUST_1
IT-DIST_1
EN-CUST_1
EN-DIST_1

Vk_20201120_23

29.12.2020

Abbott Point of Care

i-STAT CG8+ Cartridge
Model: 03P88-25
Lot: See Cartridge Lot list attached

i-STAT EG7+ Cartridges
Model: 03P76-25
Lot: See Cartridge Lot list attached

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

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

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

Vk_20201228_03

24.12.2020 

(Updated 29.12.2020)

Medartis AG

MODUS and MODUS 2 Pliers
Model: M2-2016, M-2016, M-2125
Lot: see FSN

MD: General internal orthopaedic fixation system implantation kit

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

Vk_20201217_28

22.12.2020 

(Updated 29.12.2020)

Likamed GmbH

Selexa
S/N: 14XBL0001 – 19XBL0024

MD: Bed chair

DE-1
FR-1
IT-1

Vk_20201216_10

22.12.2020 

(Updated 28.12.2020)

HeartWare Inc.

HeartWare Ventricular Assist System – HVAD Pump Implant Kit
Model: 1104
S/N: see FSN

AIMD: Implantable ventricular circulatory assist system

DE-1
EN-1

Vk_20201218_18

24.12.2020

Bioventus, LLC

EXOGEN Ultrasound Gel
Lot: 190204, 190211, 190213, 190226, 190228, 190230, 190235, 190235T, 190250, 190251,190252, 90263, 200201, 200203, 200207, 200212, 200212T, 200215, 200218, 200215T, 200227, 200228, 200228T, 200229, 200240, 200240T
S/N: N/A
SW-Version: N/A

MD: Coupling gel, non-sterile

DE-1
FR-1

Vk_20201221_07

24.12.2020

Dexcom, lnc.

Dexcom G6 sensor
Model: All sensors
Lot: All sensors
S/N: All sensors
SW-Version: N.A.

MD: Percutaneous interstitial-fluid glucose monitoring system

DE-1
FR-1
IT-1

Vk_20201207_03

23.12.2020

Ortho-Clinical Diagnostics, Inc

ORTHO VISION Analyser
Model: 6904579
SW-Version: 5.12.8;5.13.0

ORTHO VISION Max Analyzer
Model: 6904578
SW-Version: 5.12.8;5.13.0

IVD: Blood group/antibody screening analyser IVD, automated

IVD: Blood group/antibody screening analyser IVD, automated

DE-1
IT-1
EN-1

Vk_20201221_18

23.12.2020

Siemens Healthcare GmbH, HC SV DS,

ARTIS pheno systems
Model: 10849000
SW-Version: VE20B

ARTIS Icono Biplane
Model: 11327600
SW-Version: VE20B

ARTIS icono floor
Model: 11327700
SW-Version: VE20B

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

Vk_20201218_15

23.12.2020

Zimmer Patient Care Division

Spinal Rod Cutter
Model: N/A;N/A
Lot: Item number: 00-3925-002-00; all lots
S/N: N/A
SW-Version: N/A

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1
FR-1

Vk_20201217_24

23.12.2020

Spacelabs Healthcare Ltd

SENTINEL
Model: 98200 & 98201; software versions 10.0, 10.0.1, 10.0.2, 10.5 , 11.0 and 11.5
SW-Version: software versions 10.0, 10.0.1, 10.0.2, 10.5 , 11.0 and 11.5

MD: Cardiology information system application software

EN-1

Vk_20201215_15

18.12.2020 

(Updated 23.12.2020)

Mathys Ltd Bettlach

Affinis Inverse glenosphere vitamys
Model: 62.34.0060; 62.34.0061; 62.34.0062
Lot: see FSN
S/N: N/A
SW-Version: N/A

Affinis Inverse glenosphere PE
Model: 60.30.3036; 60.30.3039; 60.30.3042
Lot: see FSN

MD: Artificial shoulder joint

MD: Artificial shoulder joint

EN-2

Vk_20201210_31

31.07.2019 

(Updated 23.12.2020)

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Folate, ADVIA Centaur XP Folate, ADVIA Centaur XPT Folate
Model: See FSN
Lot: See FSN

IVD: Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

EN-1
EN-2

Vk_20190729_11

22.12.2020

Medtronic Inc.

Intellis Clinician Programmer Application
Model: A710
SW-Version: 1.3.80

AIMD: Multiple active implantable device programmer

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

Vk_20201222_01

22.12.2020

Roche Diagnostics GmbH

Electrolyte Analyzer
Model: 03157334001
SW-Version: all versions

IVD: Ion-selective analyser IVD, automated

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

Vk_20201221_19

22.12.2020

Actim Oy

Actim CRP Test
Model: 31031ETAC
Lot: 0044998 (exp 2021-09-30), 0045277 (exp 2021-11-11)
SW-Version: NA

IVD: C-reactive protein kit

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

Vk_20201218_21

22.12.2020

MAQUET Cardiopulmonary GmbH

Pediatric Venous Hardshell Cardiotomy Reservoir
Model: 701050111, 701053454, 701049185, 701053455, 701048595, 701051432, 701054166, 701070422;701050111, 701053454, 701049185, 701053455, 701048595, 701051432, 701054166, 701070422
Lot: see FSN

MD: Cardiotomy reservoir

EN-1

Vk_20201218_20

22.12.2020

Phadia AB

EliA dsDNA Well
Model: 14-5500-01
Lot: BFA3Y/0142

IVD: Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay

DE-1
FR-1

Vk_20201217_26

22.12.2020

Telemis

Telemis-Medical
SW-Version: All versions from 4.80-u00 up to 4.95-u00.3

MD: Picture archiving and communication system

FR-1
EN-1

Vk_20201217_03

22.12.2020

Illumina, Inc

VeriSeq NIPT Solution v2
Model: 20030577
Lot: see FSN

IVD: Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

DE-1
FR-1
IT-1

Vk_20201215_18

22.12.2020

SSI Diagnostica A/S

Pneumococcus CWPS
Model: 3459
Lot: ZCWPS1-1

IVD: Streptococcus pneumoniae total antibody IVD, reagent

EN-1

Vk_20201215_13

21.07.2020 

(Updated 22.12.2020)

Ortho Clinical Diagnostics Inc.

Vitros Chemistry Products BuBc Slides
Model: 8383051; 1612365
Lot: all lots

VITROS Chemistry Products TBIL Slides
Model: 8159931
Lot: all lots

VITROS XT Chemistry Products TBIL-ALKP Slides
Model: 6844296
Lot: all lots

Vitros Chemistry Products TP Slides
Model: 8392292

Vitros XT Chemistry Products ALB-TP Slides
Model: 6844293

IVD: Multiple clinical chemistry analyte IVD, reagent

IVD: Total bilirubin IVD, reagent

IVD: Multiple clinical chemistry analyte IVD, reagent

IVD: Total protein IVD, reagent

IVD: Multiple clinical chemistry analyte IVD, reagent

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

Vk_20200717_22

15.12.2020 

(Updated 21.12.2020)

Medtronic Inc.

ARES Antibiotic-Impregnated Catheter
Model: 91101, 93092, 95001
Lot: See FSN

MD: Intracerebral infusion/drainage catheter, long-term

FR-1
EN-1

Vk_20201211_02

15.12.2020 

(Updated 21.12.2020)

Medtronic MiniMed

CareLink Therapy Management Software for Diabetes
Model: MMT-7333, MMT-7350
SW-Version: v14.1a, v3.1a

MD: Self-care monitoring/reporting software

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

Vk_20201209_03

15.09.2020 

(Updated 18.12.2020)

Bien-Air Surgery SA

Foot Pedals
Model: 1600407 / 1600517 / 1600686
S/N: see FSN

MD: Foot-switch, electrical

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

Vk_20200910_02

15.12.2020 

(Updated 17.12.2020)

GE Healthcare

Centricity High Acuity Critical Care

MD: Patient health record information system

DE-1
FR-1
IT-1

Vk_20201214_03

17.12.2020

Siemens Healthcare GmbH, HC SV DS,

Artis zee/Q/Q.zen systems
Model: see FSN

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20201208_17

16.12.2020

Qiagen GmbH

therascreen PIK3CA RGQ PCR Kit (24)
Model: 873111
Lot: see FSN
S/N: see FSN

IVD: Other Acquired Gene or Chromosome Alteration Tests

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

Vk_20201211_17

16.12.2020

Mar-Med

Tourni-Cot Universal
Model: TCU – 6001
Lot: All
S/N: All

MD: Finger/toe tourniquet, sterile

EN-1

Vk_20201207_05

15.12.2020

Richard Wolf GmbH

LASERFASER Ø 272µM EINWEG
Model: 487501272
Lot: C203606

MD: Laser lithotripsy system

DE-1
FR-1

Vk_20201209_05

15.12.2020

Gentian AS

Gentian Cystatin C Calibrator Kit
Model: Gentian: 1051, 1012, 8012, 8051, Beckman Coulter: A52763
Lot: 1809403, 1809404, 1904403, 1904404, 1905415, 1906402

IVD: Cystatin C IVD, calibrator

DE-1
FR-1
IT-1

Vk_20200902_08

14.12.2020

NuVasive, Inc.

MAGEC System

MD: Spinal distraction rod

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

Vk_20201204_09

04.12.2020 

(Updated 11.12.2020)

Hamilton Medical AG

HAMILTON-H900 Humidifier
Model: 950001, 950004
S/N: All serial numbers with software version 1.10c
SW-Version: 1.10c

MD: Humidifiers, Artificial Airway, Heated

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

Vk_20201204_08

11.12.2020

Cardiac Pacemakers, Inc, (Boston Scientific Corporation)

Emblem S-ICD
Model: A209
Lot: see FSN
SW-Version: N/A

Emblem MRI S-ICD
Model: A219
Lot: see FSN

AIMD: Single-chamber implantable defibrillator

AIMD: Single-chamber implantable defibrillator

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

Vk_20201203_10

11.12.2020

Cardiac Pacemaker Inc

EMBLEM S-ICD Subcutaneous Electrode (Lead)
Model: Model 3501
Lot: N/A
S/N: All
SW-Version: N/A

AIMD: Endocardial defibrillation lead

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

Vk_20201203_08

02.12.2020 

(Updated 11.12.2020)

Hitachi High Technologies Corporation (HHT)

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
FR-1
IT-1
EN-1

Vk_20201130_17

11.12.2020

SenTec AG

SenTec Digital Monitor
Model: SDM
S/N: All SenTec Digital Monitors used in home healthcare environments

MD: Transcutaneous blood gas monitoring system

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

Vk_20201127_11

02.12.2020 

(Updated 10.12.2020)

Roche Molecular Systems Inc.

cobas z 480 analyzer
Model: 05200881001

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

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

Vk_20201124_09

16.11.2020 

(Updated 10.12.2020)

Geratherm Medical AG

Geratherm Patient Warming System
Model: 8001150500, 8001150501
S/N: L20041403

Arm-Schulter-Decke eines Geratherm patientenwärmesystems UniqueTemp Patientenwärmesystems UniqueTemp

MD: Electric pad whole-body heating system control unit

MD: Electric pad whole-body heating system pad

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

Vk_20201111_17

09.12.2020

The Binding Site Group Limited

Optilite Freelite Kappa Free Kit
Model: LK016.OPT; LK016.10.OPT; LK016.M.OPT
Lot: 432689; 433444; 437316

IVD: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

DE-1
FR-1
EN-1

Vk_20201203_02

09.12.2020

PETER BREHM GmbH

Titanium Flat-head Spongiosa screw Ø 6,5 x 40 mm
Model: 51265-40+01
Lot: 395225

MD: Grafts, Bone

DE-1
EN-1

Vk_20201201_12

02.12.2020 

(Updated 09.12.2020)

Seramun Diagnostica GmbH

Serazym Bovine Serum Albumin (BSA) sensitive
Model: E-108
Lot: 14-05-19, 15-04-20

IVD: Specific Proteins

DE-1
EN-1

Vk_20201125_11

08.12.2020

Welch Allyn Inc

ELI 380 Resting Electrocardiograph

MD: Electrocardiograph, professional, multichannel

EN-1

Vk_20201207_16

08.12.2020

Smiths Medical ASD, Inc.

Portex Loss Of Resistance Device
Model: 100/398/000
Lot: 3980977, 3986734, 3994302, 3994303, 4001003

MD: Low-resistance epidural syringe

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

Vk_20201207_02

08.12.2020

ConvaTec Limited

Aquacel Ag Hydrofiber Dressing with silver
Model: 403470
Lot: 9E00552, 9J01887

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

DE-1
FR-1
IT-1

Vk_20201202_02

08.12.2020

Boston Scientific Corporation

AXIOS Stent and Electrocautery – Enhanced Delivery System
Model: M00553640, M00553650, M00553660
Lot: see FSN

Hot AXIOS Stent and Electrocautery – Enhanced Delivery System
Model: M00553540, M00553550, M00553560
Lot: see FSN

MD: Implantable transenteric drainage tube

MD: Implantable transenteric drainage tube

DE-1
EN-1

Vk_20201201_08

08.12.2020

Implantcast GmbH

EcoFit Cup cementless / EcoFit Cup EPORE cementless
Model: ECOCUOPD, ECOEPOPD, 09300038
S/N: alle

MD: hip cup

DE-1
EN-1

Vk_20201201_03

08.12.2020

Siemens Healthcare Diagnostics Inc

ADVIA GGT reagent
Model: 10309495 (20ml); 10316298 (70ml)
Lot: see FSN

Atellica GGT reagent
Model: 11097597
Lot: see FSN

IVD: Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry

IVD: Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry

DE-1_ADVIA
DE-1_Atellica
FR-1_Atellica

Vk_20201130_13

03.11.2020 

(Updated 08.12.2020)

Medtronic MiniMed

CareLink Therapy Management Software for Diabetes
Model: MMT-7333, MMT-7350
SW-Version: v14.1a, v3.1a

MD: Self-care monitoring/reporting software

DE-2.1
DE-2.2
FR-2.1
FR-2.2
IT-2.1
IT-2.2
EN-1.1
EN-1.2
EN-2.1
EN-2.2

Vk_20201102_03

07.12.2020

Siemens Healthcare GmbH

SOMATOM
Model: 8098027, 10590000, 10430603, 10431700, 10742326, 10590100, 10267000
S/N: For details see attached consignee list. All Siemens CT scanners running on software syngo CT VB20A_SP2 are affected.
SW-Version: syngo CT VB20A_SP2

MD: Full-body CT system

DE-1
FR-1
IT-1

Vk_20201207_14

25.11.2020 

(Updated 07.12.2020)

Mikrogen GmbH

AmpliCube Coronavirus SARS-CoV-2
Model: 50143
Lot: ACVS042004

IVD: Other Virology – NA Reagents

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

Vk_20201118_16

28.08.2019 

(Updated 07.12.2020)

Cardiac Pacemakers, Inc, (Boston Scientific Corporation)

Emblem S-ICD
Model: A209

Emblem MRI S-ICD
Model: A219

AIMD: Single-chamber implantable defibrillator

AIMD: Single-chamber implantable defibrillator

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

Vk_20190821_15

04.12.2020

Cook Incorporated

Flexor Check-Flo Introducer
Model: See FSN
Lot: See FSN

Flexor Tuohy-Borst Side-Arm Introducer
Model: See FSN
Lot: See FSN

MD: Vascular catheter introduction set, nonimplantable

MD: Vascular catheter introduction set, nonimplantable

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

Vk_20201125_21

03.12.2020

Medela AG

AXS Universal Aspiration Tubing
Model: 077.0193
Lot: W-024423

MD: Suction/irrigation tubing, single-use

DE-1
FR-1
IT-1

Vk_20201202_09

26.11.2020 

(Updated 03.12.2020)

Schiller AG

Tempus LS
Model: 1A.702100; 00-30 10
SW-Version: 1.3.4

MD: Physiologic-monitoring defibrillation system

DE-1
EN-1

Vk_20201119_20

03.12.2020

Covidien LLC

Puritan Bennett 840 Ventilator
S/N: All

MD: Neonatal/adult intensive-care ventilator

EN-1

Vk_20201117_17

02.12.2020

DiaSorin Inc

LIAISON 1-84 PTH Assay
Model: 310630
Lot: 134909, 134909A, 134909B

IVD: Parathyroid hormone (PTH) terminal fragment IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20201130_02

02.12.2020

Helena Biosciences Europe

APTT Si L Minus
Model: 5558SLQ, 5559SLQ, 5560SLQ, 5562SLQ
Lot: see FSN
SW-Version: N/A

APTT (SILICA)
Model: OQLS065502, OQLS265502, OQLS365502, OQLS493502, OQLS955502
Lot: see FSN

IVD: Activated partial thromboplastin time (APTT) IVD, kit, clotting

IVD: Activated partial thromboplastin time (APTT) IVD, kit, clotting

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

Vk_20201123_05

02.12.2020

aacurat gmbh

pulla Strechlift
Model: 8266001
S/N: 0001 to 3738

MD: Strechlift

DE-1
EN-1

Vk_20201112_27

01.12.2020

Covidien LLC

TATM Auto SutureTM Vascular Loading Unit with DST SeriesTM Technology 30mm -V3
Model: TA30V3L
Lot: see FSN

TA Auto SutureTM Vascular Stapler with DST SeriesTM Technology 30mm -V3
Model: TA30V3S
Lot: see FSN

MD: Surgical staple loading unit, non-cutting

MD: Open-surgery manual linear stapler, single-use

DE-1

Vk_20201127_12

01.12.2020

Philips Ultrasound Inc.

EPIQ Ultrasound System
Model: EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx
SW-Version: 1.0.x, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.7.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, 5.0.1.

Affiniti Ultasound System
Model: Affiniti 30, Affiniti 50 and Affiniti 70
SW-Version: 1.0.x, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.7.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, 5.0.1.

MD: General-purpose ultrasound imaging system

MD: General-purpose ultrasound imaging system

DE-1-CUSTOMER
DE-1-DISTRIBUTOR
FR-1-CUSTOMER
IT-1-CUSTOMER
EN-1-CUSTOMER
EN-1-DISTRIBUTOR

Vk_20201125_18

01.12.2020

STERIS Canada Corporation

Reliance Vision Single Chamber Washer Disinfector

MD: Surgical utensil washer/disinfector

EN-1

Vk_20201123_09

25.11.2020 

(Updated 27.11.2020)

Olympus Medical Systems Corp.

GF-EUS ultrasound endoscope
Model: GF-UC140P-AL5 & GF-UCT140-AL5 & GF-UE160-AL5 & GF-UE260-AL5 & GF-UCT260 & GF-UCT180 & GF-UE190 & GF-UE290 & GF-UC240P-AL5 & GF-UCT240-AL5 & GF-UM20 & GF-UM130 & GF-UMQ130 & GF-UMP230 & CF-UMQ230 & & GF-UM240 & GF-UMQ240 & GF-UM160 & GF-UC160P-OL5 & GF-UCT
S/N: all

MD: GMDN=36951/38807

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

Vk_20201117_14

16.11.2020 

(Updated 27.11.2020)

Vivostat A/S

Vivostat Disposables – single use devices
Model: VS302, VS312, VS322, VS323, VS400, VS410, VS420, VS422, VS305, VS315, VS325, VS335, VS345, VS355, VS306, VS406, GM700, GM720, GM740

MD: Vivostat Disposables

DE-1
EN-1

Vk_20201113_17

26.11.2020

VLVbio AB

M30 Apoptosense ELISA
Model: 10011
Lot: 10011-008

IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)

DE-1
EN-1

Vk_20201120_19

11.11.2020 

(Updated 26.11.2020)

ESAOTE S.P.A.

MyLab
Model: see FSN
S/N: see FSN

MD: General-purpose ultrasound imaging system

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

Vk_20201103_21

26.11.2020 

(Updated 26.11.2020)

Cardinal Health

Protexis Latex Micro Surgical Gloves
Model: 2D72NT55X, 2D72NT60X, 2D72NT65X, 2D72NT70X, 2D72NT75X , 2D72NT80X, 2D72NT85X, 2D72NT90X
Lot: see FSN

MD: Hevea-latex surgical glove, non-powdered, non-antimicrobial

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

Vk_20201023_03

26.05.2020 

(Updated 26.11.2020)

Zimmer GmbH

Anaverse Glenoid Liner
Model: 01.04440.011; 01.04440.012;01.04440.013;01.04440.014;
Lot: See FSN

MD: Shoulder glenoid fossa prosthesis, prefabricated

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

Vk_20200519_01

25.11.2020 

(Updated 25.11.2020)

Leica Biosystems Newcastle Ltd

NCL-L-vWF
Model: NCL-L-vWF
Lot: 6071415
S/N: NA

IVD: HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY

DE-1
FR-1
EN-1

Vk_20201119_10

25.11.2020

DOC medikus GmbH

OncoSet Y-Link
Model: DOC 31006
Lot: 2020-07120, 2020-07142

MD: Infusion administration set

DE-1

Vk_20201118_13

17.11.2020 

(Updated 25.11.2020)

Welch Allyn Inc

ELI 380 Electrocardiograph
Model: see FSN
SW-Version: ELI 380 software version 2.4.1 and 2.4.2

MD: Electrocardiograph, general-purpose

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

Vk_20201112_04

07.09.2020 

(Updated 25.11.2020)

Medtronic (Schweiz) AG

Cobalt XT DR MRI SureScan
Model: DDPA2D4
S/N: RSM601557S

Cobalt XT HF CRT-D MRI SureScan
S/N: see FSN

MD: Dual-chamber implantable defibrillator

MD: Dual-chamber implantable defibrillator

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

Vk_20200806_09

24.11.2020

Karl Storz Endoskope SE und Co. KG

HYSTEROMAT E.A.S.I. SCB
Model: 26340020-1
S/N: all

MD: Surgical irrigation/aspiration system

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

Vk_20201123_08

24.11.2020

Galil Medical Ltd.

Cryoablation Needles
Model: see FSN
Lot: see FSN

MD: Cryosurgical set

DE-1
FR-1
EN-1

Vk_20201119_24

24.11.2020

Aesculap AG

AESCULAP Univation X System
Model: see FSN

MD: Unicondylar knee insert

DE-1

Vk_20201117_04

24.11.2020

Synthes GmbH

RIA 2 (Reamer Irrigator Aspirator)
Model: see FSN
Lot: all

MD: Medullary canal orthopaedic reamer, flexible

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

Vk_20201103_05

18.11.2020 

(Updated 23.11.2020)

BIONOTE, Inc.

Nowcheck COVID-19 Ag Test
Model: RG1901DG
Lot: 1901D001, 1901D002, 1901D003, 1901D004, 1901D005

IVD: Other Other Virology – RT & POC

DE-1
IT-1
EN-1

Vk_20201116_11

18.11.2020 

(Updated 23.11.2020)

Abbott

Alinity i Active-B12 (Holotranscobalamin)
Model: 09P2625; 09P2635; 09P2602; 09P2611
Lot: 11093UP00; 11095UP00; 11096UP00; 11094UP00

ARCHITECT Active-B12 (Holotranscobalamin)
Model: 3P24-28; 3P24-38; 3P24-02; 3P24-11
Lot: 11089UP00; 11090UP00; 902933475; 902933926; 902933474

IVD: Vitamin B12 IVD kit, chemiluminescent immunoassay

IVD: Vitamin B12 IVD kit, chemiluminescent immunoassay

DE-1 (Alinity)
DE-1 (Architect)
FR-1 (Architect)
IT-1 (Architect)
EN-1 (Alinity)
EN-1 (Architect)

Vk_20201113_22

17.11.2020 

(Updated 23.11.2020)

Mazor Robotics Ltd.

Mazor X
Model: ASM0214-02

MD: Multi-purpose stereotactic surgery system

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

Vk_20201113_03

20.11.2020

Boston Scientific Corporation

LOTUS Edge Valve System
Model: H749LVS230, H749LVS250, H749LVS270, H749LVSUS230, H749LVSUS250, H749LVSUS270, H749LVSCL230, H749LVSCL250, H749LVSCL270
Lot: All
SW-Version: N/A

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

DE-1
EN-1

Vk_20201116_09

18.11.2020 

(Updated 20.11.2020)

Siemens Healthcare Diagnostics Inc

Atellica CH – Enzymatic Creatinine (Ecre_2), Fructosamine (Fruc), Glucose Oxidase (GluO), Lactate (Lac), Triglycerides (Trig), Japan enzymatic creatinine (EcreJ), Lactate_2 (Lac_2)
Model: see FSN
Lot: all

Dimension – Enzymatic Creatinine (EZCR), Triglycerides (TGL)
Model: see FSN
Lot: all

ADVIA Chemistry – Enzymatic Creatinine (ECRE_2), Fructosamine (FRUC), Glucose Oxidase (GLUO), Lactate (LAC), Triglycerides (TRIG_2), Glucose Oxidase Concentrated (GLUO_c), Triglycerides_2 concentrated (TRIG_c)
Model: see FSN
Lot: all

Dimension Vista – Enzymatic Creatinine (ECREA), Triglycerides (TRIG)
Model: see FSN
Lot: all

IVD: CLINICAL CHEMISTRY

IVD: CLINICAL CHEMISTRY

IVD: CLINICAL CHEMISTRY

IVD: CLINICAL CHEMISTRY

DE-1 (ADVIA Chemistry)
DE-1 (Atellica CH)
DE-1 (Dimension Vista)
DE-1 (Dimension)
FR-1 (ADVIA Chemistry)
FR-1 (Atellica CH)
FR-1 (Dimension Vista)
FR-1 (Dimension)
EN-1 (ADVIA Chemistry)
EN-1 (Atellica CH)
EN-1 (Dimension Vista)
EN-1 (Dimension)

Vk_20201111_19

19.11.2020

I2A – Intelligence Artificielle Applications SA

SIRscan disc CEFOXITINE 30 µg
Model: 061024/065024
Lot: 200318A

IVD: Antimicrobial reagents disks

DE-1
FR-1
EN-1

Vk_20201116_07

11.11.2020 

(Updated 19.11.2020)

MAQUET Cardiopulmonary GmbH

HLS Set Advanced
Model: 70104.7753; 70104.8127
Lot: see FSN

HIT Set Advanced
Model: 70104.9134
Lot: see FSN

MD: Cardiopulmonary bypass system tubing set

MD: Cardiopulmonary bypass system tubing set

DE-1
FR-1
EN-1

Vk_20201109_01

17.11.2020 

(Updated 19.11.2020)

BD Switzerland Sàrl

Alaris GW volumetric Pump
Model: Refer to FSN
S/N: All
SW-Version: N/A

Alaris GW800 Volumetric Pump
Model: Refer to FSN
S/N: All

MD: General-purpose infusion pump, line-powered

MD: General-purpose infusion pump, line-powered

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

Vk_20201106_13

17.11.2020

Gelita Medical GmbH

GELITA-SPON Standard
Model: GS-010
Lot: T02215/1

MD: Gelatin haemostatic agent

EN-1

Vk_20201116_01

17.11.2020

GE Medical Systems Information Technologies, Inc.

MAC VU360 Resting ECG Analysis System
Model: 2030360-001
SW-Version: MAC VU360 V1.01 SP06 and any prior versions

MD: Electrocardiograph, professional, multichannel

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

Vk_20201112_30

17.11.2020

Respironics California, LLC

V60 Ventilator
Model: V60
S/N: See FSN

V60 Plus Ventilator
Model: V60 Plus
S/N: see FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

DE-1
FR-1
EN-1

Vk_20201112_10

17.11.2020

RaySearch Laboratories AB

RayStation
Model: see FSN

MD: Radiation therapy software

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

Vk_20201111_21

27.10.2020 

(Updated 16.11.2020)

Laerdal Medical AS

Laerdal Compact Suction Unit

MD: Emergency airway clearance suction system, electric

DE-1
FR-1
IT-1

Vk_20201026_25

10.11.2020 

(Updated 12.11.2020)

GA Health Company Limited

Andorate Disposable Valves Set
Model: GAR046
Lot: 19102223, 19102224, 20061807

MD: Endoscopic suction valve, single-use, sterile

DE-1
FR-1
EN-1

Vk_20201106_03

12.11.2020

Biomet Orthopedics

Regenerex Primary Taper Cap
Model: see FSN
Lot: see FSN

MD: Coated knee tibia prosthesis

DE-1
EN-1

Vk_20201020_15

22.10.2020 

(Updated 12.11.2020)

Rocket Medical PLC

Rocket KCH Fetal Bladder Drain
Model: R57405
Lot: 000000000475024, 000000000479735, 000000000482145, 000000000488912

MD: Suprapubic drainage catheter

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

Vk_20201014_14

12.11.2020

Biomet Orthopedics

OnPoint Scope Procedure Kits and Arthrosimplicity Kits
Model: see FSN
Lot: see FSN

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

DE-1
EN-1

Vk_20201014_04

03.06.2019 

(Updated 12.11.2020)

EKOS Corporation inc.

EKOS Control System 4.0

MD: Ultrasound thrombolysis system control unit

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

Vk_20190527_03

11.11.2020

BD Switzerland Sàrl

Alaris GP Volumetric Pump with Plus software
Model: 9002TIG03
S/N: 400008724 to 400009451

Alaris GP Guardrails Volumetric Pump with Plus software
Model: 9002TIG03-G
S/N: 470034144 to 470044446

Alaris neXus GP
Model: GPNEXUS1
S/N: 410000002 to 410004377

MD: General-purpose infusion pump, line-powered

MD: General-purpose infusion pump, line-powered

MD: General-purpose infusion pump, line-powered

DE-1
EN-1

Vk_20201103_16

04.11.2020 

(Updated 10.11.2020)

Siemens Healthcare Diagnostics Inc

Atellica IM 1300
Model: 11066001
Lot: N/A
S/N: N/A
SW-Version: V1.23.1 and lower

Atellica IM 1600
Model: 11066000
Lot: N/A
S/N: N/A
SW-Version: V1.23.1 and lower

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1
FR-1
EN-1

Vk_20201028_03

09.11.2020

Chromsystems Instruments & Chemicals GmbH

3PLUS1 Multilevel Plasma Calibrator Set
Model: 75128
Lot: 2219 and 2320

MassChrom Amino Acid Analysis Plasma Control Level I-III
Model: 0471, 0472, 0473
Lot: 2019

IVD: Multiple amino acid IVD, calibrator

IVD: Multiple amino acid IVD, control

DE-1
FR-1
IT-1

Vk_20201104_44

30.10.2020 

(Updated 09.11.2020)

Illumina, Inc

NextSeq550Dx High Output Reag. Kit v2.5, 75 cycles
Model: 20028870
Lot: A159626-1

IVD: Nucleic acid sequencing reagent kit IVD

FR-1
EN-1

Vk_20201021_16

09.11.2020

Optotek d.o.o.

OptoYag & SLT M
Model: N1001 / 83 9 00 000 M – S8
Lot: 08
S/N: 83 08 031

MD: Laser, Nd:YAG

EN-1

Vk_20201008_23

09.04.2020 

(Updated 09.11.2020)

Beckman Coulter Ireland, Inc.

iChemVELOCITY Automated Urine Chemistry System
Model: 700-7176-001, 700-7177-001, 700-7087, B75502, B75503.
Lot: Not applicable

iQ200 Series Urine Microscopy Analyzer
Model: 700-3345, 700-3375, 700-3325, 700-3347, 700-3326, 700-3370, 700-3320, 700-3322, 700-3340, 700-3320RFB, B48999, 700-3376, C10683.
Lot: Not applicable

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

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

Vk_20200407_01

02.11.2020 

(Updated 06.11.2020)

P. J. Dahlhausen & Co.GmbH

Disposable Laryngoscope handle for adults
Lot: FM167

MD: Laryngoscope handle, reusable

DE-1
EN-1

Vk_20201102_19

06.11.2020

SIS Medical AG

BEO NC PTCA Catheters
Model: See FSN
Lot: All lot numbers produced since 1 May 2017

MD: Coronary angioplasty balloon catheter, basic

DE-1
FR-1
IT-1

Vk_20201026_22

06.11.2020

SIS Medical AG

OPN NC
Model: See FSN
Lot: All lot numbers produced since 1 May 2017

MD: Coronary angioplasty balloon catheter, basic

DE-1
FR-1
IT-1

Vk_20201026_21

03.11.2020 

(Updated 05.11.2020)

Abbott GmbH & Co. KG

ARCHITECT EBV VCA IgM Calibrator
Model: 3P66-01
Lot: 08159BE00

IVD: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, calibrator

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

Vk_20201102_01

28.10.2020 

(Updated 05.11.2020)

Medtronic CoreValve LLC

CoreValve Evolut R Transcatheter Aortic Valve
Model: EVOLUTR-23, EVOLUTR-26, EVOLUTR-29, EVOLUTR-34
S/N: all

CoreValve Evolut PRO Transcatheter Aortic Valve
Model: EVOLUTPRO-23, EVOLUTPRO-26, EVOLUTPRO-29
S/N: all

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

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

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

Vk_20201026_01

04.11.2020

Chromsystems Instruments & Chemicals GmbH

6PLUS1 Multilevel Saliva Calibrator Set
Model: 73039
Lot: 3219 and 1020

MassChrom Cortisol, Cortisone Saliva Control Level I
Model: 0349
Lot: 3219 and 1020

MassChrom Cortisol, Cortisone Saliva Control Level II
Model: 0350
Lot: 3219 and 1020

IVD: Cortisol

IVD: Cortisol

IVD: Cortisol

DE-1
FR-1
IT-1

Vk_20201102_13

04.11.2020

Thermo Fisher Scientific Microbiology Basingstoke

Thermo Scientific Oxoid Brilliance Staph24 Agar
Model: PO1186A
Lot: 4276065

IVD: Prepared Microbial Culture Media

DE-1
EN-1

Vk_20201030_09

03.11.2020 

(Updated 03.11.2020)

TRACOE medical GmbH

TRACOE twist plus, TRACOE experc Set twist plus
Model: REF 316-07, REF 316-08, , REF 316-07-P, REF 316-08-P, , REF 888-316-07, REF 888-316-08, , REF 888-316-07-P, REF 888-316-08-P, REF 332-07, REF 332-08, , REF 888-332-07, REF 888-332-08;n.a.
Lot: See list attached to the report.
S/N: n.a.
SW-Version: n.a.

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

DE-1
FR-1
EN-1

Vk_20201027_13

18.12.2019 

(Updated 03.11.2020)

Fast-Track Diagnostics S.a.r.l.

FTD CE-IVD Kits
Model: see FSN
Lot: see FSN

IVD: IVD kits for the detection of various pathogens

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_20191216_14

03.09.2019 

(Updated 03.11.2020)

Roche Diagnostics GmbH

ALB2 (Albumin Gen.2)
Model: 05166861190 on cobas c 701/702
Lot: 33962301; 37437301; 43031001; 43718901

BILT3 (Bilirubin Total Gen.3)
Model: 05795419190 on cobas c 701/702
Lot: 36133801

C4-2 (Tina-quant Complement C4 ver.2)
Model: 05991994190 on cobas c 701/702
Lot: 36870301

IVD: Albumin IVD, kit, spectrophotometry

IVD: Total bilirubin IVD, kit, spectrophotometry

IVD: Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

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

Vk_20190828_10

02.11.2020

Stryker Instruments

ZYPHR PERFORATOR BIT
Model: 5100060001
Lot: see FSN

MD: Automatic cranial perforator, single-use

DE-1
FR-1
IT-1

Vk_20201023_02

 

 

 

 

DE-1

Vk_20201030_07

 

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