Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2022 – 31.12.2022

Date

Manufacturer

Trade name

Product description

Information

Swissmedic reference

30.12.2022

Mobius Imaging, LLC

AIRO CT SCANNER
Model: MOBICT-32
S/N: All

MD: GMDN=00869346000200

DE-1
FR-1
IT-1

Vk_20221223_36

30.12.2022

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 8111808469

MD: Extracorporeal membrane oxygenator

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

Vk_20221221_01

20.12.2022

(Updated 30.12.2022)

Macopharma

Storage solution for blood platelets SSP+
Lot: see FSN

MD: Platelet storage solution

EN-1
EN-2

Vk_20221213_25

29.12.2022

GE Medical Systems Israel Functional Imaging

Nuclear medicine system / X-Ray system, CT
Model: Brivo 615, Discovery NM 630, Optima 640, Discovery NM/CT 670 DR, Discovery NM/CT 670 ES, Discovery NM/CT 670 Pro, Discovery NM/CT 670 CZT, NM 830, NM 830 ES, NM/CT 850, NM/CT 850 ES, NM/CT 860, NM/CT 860 ES, NM/CT 870 CZT, NM/CT 870 DR, NM/CT 870 ES
Lot: see FSN
S/N: see FSN

MD: Stationary gamma camera system

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

Vk_20221223_37

22.12.2022

(Updated 29.12.2022)

LiNA Medical ApS

Lina Librata
Model: LIB-1

MD: Circulating-fluid endometrial-ablation catheter

DE-1
EN-1

Vk_20221215_25

29.12.2022

Endo-Flex GmbH

Biopsy Forceps SU
Model: NE0230-G, NE1618-C, NE6122-G,
Lot: 170519014 - 220302014

MD: Flexible endoscopic biopsy forceps, single-use

EN-1

Vk_20221215_23

28.12.2022

Schiller Medical

Schiller Defigard Touch 7
Model: DEFIGARD Touch7
S/N: All
SW-Version: Soft 8 and lower

MD: Physiologic-monitoring defibrillation system

DE-1
FR-1
IT-1

Vk_20221228_01

28.12.2022

Siemens Healthcare GmbH

SOMATOM go
Model: 11061610, 11061620, 11061623, 11061628, 11061630, 11061638, 11061640, 11061648, 11061660, 11061670
S/N: All systems that have myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license or myNeedle Guide 3D license

SOMATOM X.ceed
Model: 11330002
S/N: All systems that have myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license or myNeedle Guide 3D license

SOMATOM X.cite
Model: 11330001
S/N: All systems that have myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license or myNeedle Guide 3D license

NAEOTOM Alpha
Model: 11330003
S/N: All systems that have myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license or myNeedle Guide 3D license

MD: Full-body CT system

MD: Full-body CT system

MD: Full-body CT system

MD: Full-body CT system

DE-1
FR-1

Vk_20221223_33

27.12.2022

Roche Molecular Systems, Inc.

cobas SARS-CoV-2 & Influenza A/B
Model: 09233474190; 09446125190

cobas Influenza A/B & RSV UC
Model: 09233962190

IVD: SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)

EN-1

Vk_20221227_01

27.12.2022

Ortho Clinical Diagnostics

ORTHO VISION Analyser
Model: 6904579
Lot: Not Applicable
S/N: Not Applicable
SW-Version: all

ORTHO VISION Max Analyzer
Model: 6904578
SW-Version: all

IVD: Blood group/antibody screening analyser IVD

IVD: Blood group/antibody screening analyser IVD

EN-1

Vk_20221223_30

27.12.2022

Draeger Medical Systems, Inc.

Infinity Central Station
SW-Version: VG3.0

MD: Centralized patient monitor

DE-1
FR-1
IT-1

Vk_20221223_27

27.12.2022

Philips Goldway (Shenzhen) Industrial Inc.

Efficia External Padles
Model: 989803196431;
Lot: see FSN
SW-Version: N/A

MD: External defibrillator electrode, adult, reusable

EN-1

Vk_20221223_03

27.12.2022

Philips Goldway (Shenzhen) Industrial Inc.

Efficia Pads - Adapter Cable
Model: 989803197111
Lot: see FSN

MD: Electrical-only medical device connection cable, reusable

EN-1

Vk_20221223_02

27.12.2022

Datex-Ohmeda Inc.

B125P/B105P/B125M/B105M/B155M Patient Monitor
Model: 6160000-001, 6160000-002, 6160000-003, 6160000-004, 6160000-005

MD: General-purpose multi-parameter bedside monitor

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

Vk_20221222_03

27.12.2022

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

EN-1

Vk_20221221_33

20.12.2022

(Updated 27.12.2022)

Medicvent AB

Double mask
Model: size 2; 210002
Lot: Lot 3007 / Batch 6670

MD: Anaesthetic Face Masks

DE-1
EN-1

Vk_20221216_19

06.12.2022

(Updated 27.12.2022)

CHRISTEYNS FRANCE SA

Phago'scope APA

MD: Phago'scope APA

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

Vk_20221102_13

28.10.2022

(Updated 27.12.2022)

Boston Scientific Corporation

ORISE Gel Submucosal Lifting Agent
Model: M00519200, M00519201, M00519210, M00519211, M00519220, M00519221, M00519230, M00519231, M00519380, M00519390, M00519400
Lot: all

MD: Submucosal lift solution

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

Vk_20221010_12

17.08.2022

(Updated 23.12.2022)

Respironics, Inc

Amara View
Model: See FSN

DreamWisp
Model: See FSN

DreamWear
Model: See FSN

Wisp
Model: See FSN

Therapy Mask 3100
Model: See FSN

MD: CPAP/BPAP face mask, reusable

MD: CPAP/BPAP nasal mask, reusable

MD: CPAP/BPAP face mask, reusable

MD: CPAP/BPAP nasal mask, reusable

MD: CPAP/BPAP nasal mask, reusable

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

Vk_20220817_09

18.02.2022

(Updated 23.12.2022)

NeuMoDx Molecular Inc.

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

IVD: Microplate IVD

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

Vk_20220217_57

20.12.2022

(Updated 22.12.2022)

Biocartis NV

Idylla BRAF Mutation Test
Model: A010/6
Lot: Cartridge ID numbers 58450606 to 58450656 of lot 00005845

IVD: Tests For Acquired Genetic Or Chromosomal Alterations - Other

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

Vk_20221216_12

22.12.2022

B. Braun Melsungen AG

ProSet Intrafix SafeSet
Model: 4188110; 4188114; 4188116; 4188120
Lot: 22H26F0000, 22H30F0000; 22H31F0000; 22K06F0000; 22K08F0000, 22H29F0000

ProSet Combidyn
Model: 4185687
Lot: 22K06F0000

MD: Intravenous line stopcock

MD: Intravenous line stopcock

DE-1
IT-1

Vk_20221214_24

07.12.2022

(Updated 22.12.2022)

Medtronic CoreValve LLC

Evolut PRO+ Transcatheter Aortic Valve (TAV)
Model: EVPROPLUS-34
S/N: All

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

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

Vk_20221202_03

08.03.2022

(Updated 22.12.2022)

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

Vk_20220303_16

21.12.2022

Implantcast GmbH

MUTARS HD coupling
Model: 57201230N, 57201232N, 57201233N
S/N: All manufactured parts placed on the market since market launch until 09/12/2022

MD: Rotating hinged total knee prosthesis

DE-1

Vk_20221215_02

21.12.2022

Abbott Molecular Inc.

Alinity m System
Model: 08N53-002
S/N: not serial specific

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory

DE-1
FR-1
EN-1

Vk_20221213_29

21.12.2022

Phadia AB

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

IVD: Fluorescent immunoassay analyser IVD, laboratory

DE-1
FR-1

Vk_20221213_28

20.12.2022

Siemens Healthcare GmbH

ARTIS icono biplane

ARTIS icono floor

ARTIS pheno

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_20221219_01

20.12.2022

Siemens Healthcare GmbH

Artis zee/Q/Q.zen systems
Model: see enclosure; see enclosure
S/N: Artis zee / Q / Q.zen - systems with software version VD12A

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20221216_17

20.12.2022

Maquet Critical Care AB

Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
Model: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e; Flow-i: 6677200, 6677300 , 6677400 (SN < 20000), Flow-i: 6888520, 6888530, 6888540 (SN > 20000) , Flow-c: 6887700, Flow-e: 6887900
SW-Version: 04.08.00 - 04.08.03

MD: Anaesthesia workstation, general-purpose

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

Vk_20221216_15

20.12.2022

custo med GmbH

custo cardio 400 BT and custo cardio 400 accu
Model: 85130; 85131
S/N: see FSN

MD: Electrocardiographs, Multichannel

DE-1

Vk_20221215_03

20.12.2022

Spiegelberg GmbH & Co. KG

Tunneling Silverline Ventricular
Model: Probe 8F, Probe 10F
S/N: SND13.1.14, SND13.1.15

MD: Intracerebral infusion/drainage catheter, short-term

DE-1
EN-1

Vk_20221208_26

20.12.2022

Schiller AG

Microvit MT-101, MT-101 nano
Model: 1.300000, 1.300001, 1.300010, 1.300011, 1.340010, 1.340000, 1.340011, 3.920700 , 3.920710

MD: Electrocardiographic ambulatory recorder

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

Vk_20221205_20

06.12.2022

(Updated 20.12.2022)

Fujifilm Corporation

FDR Nano
Model: DR-XD 1000
S/N: Ending on 1993 and lower

MD: Mobile basic diagnostic x-ray system, digital

DE-2
FR-2
IT-2

Vk_20221201_21

19.12.2022

VacSax Limited

Vommax
Model: 9310-003

MD: Fluid Collection Bags And Systems - Other

EN-1

Vk_20221219_13

16.12.2022

(Updated 16.12.2022)

Epocal Inc.

epoc Host 2 and epoc NXS Host
Model: see FSN
Lot: N/A
S/N: All
SW-Version: Sensor config. 41.1, Host 2 3.37.3, NXS Host 4.10.6

IVD: Metabolic profile clinical chemistry analyser IVD

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

Vk_20221214_01

16.12.2022

DePuy Ireland

BIOSTOP G Bioresorbable Cement Restrictor
Model: 5463-08-000, 5463-10-000, 5463-12-000, 5463-14-000, 5463-16-000, 5463-18-000, 5463-20-000
Lot: All lots

MD: Polymer orthopaedic cement restrictor, bioabsorbable

EN-1

Vk_20221212_01

09.12.2022

(Updated 16.12.2022)

Covidien LLC

Sofsilk
Model: S1768K; SS786
Lot: See attachment A of FSN

Novafil
Model: 8886440013; 8886441003; 8886441013; 8886442243; 8886445041; 8886445251; SPB1233G
Lot: See attachment A of FSN

Surgilon
Model: 8886188351
Lot: See attachment A of FSN

Monosof
Model: SN247
Lot: See attachment A of FSN

Surgidac
Model: D1764K
Lot: See attachment A of FSN

Ti-Cron
Model: 8886301261; 8886301561; 8886308851; 8886310943; 8886311179; 8886318541
Lot: See attachment A of FSN

Surgipro II
Model: VP541X; VP875X; VP900X; VP902X
Lot: See attachment A of FSN

DERMALON
Model: 8886174924; 8886175741
Lot: See attachment A of FSN

MD: Silk suture

MD: Polyester suture, non-bioabsorbable, monofilament

MD: Nylon suture, non-bioabsorbable, multifilament

MD: Nylon suture, non-bioabsorbable, monofilament

MD: Polyester suture, non-bioabsorbable, multifilament

MD: Polyester suture, non-bioabsorbable, multifilament

MD: Polyester suture, non-bioabsorbable, multifilament

MD: Nylon suture, non-bioabsorbable, monofilament

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

Vk_20221201_32

15.12.2022

Covidien llc

Mahurkar Acute Dual Lumen High Flow Catheter
Model: 8888135191, 8888135241, 8888135162, 8888135192, 8888135242
Lot: See FSN

MD: Double-lumen haemodialysis catheter, nonimplantable

DE-1

Vk_20221208_05

15.12.2022

Vygon - Erzeugnisse für Medizin und Chirurgie - Gesellschaft mit beschränkter Haftung und Co Kommanditgesellschaft

Multicath 2-Lumen 3F 10cm
Model: 157.114
Lot: 310522GO

MD: Centrally-inserted central venous catheter

DE-1

Vk_20221201_10

14.12.2022

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 Thyroglobulin
Model: 10381648
Lot: 431, 432, 433, 434, 435, 436

IVD: Thyroglobulin IVD, kit, chemiluminescent immunoassay

FR-1
EN-1

Vk_20221208_15

13.12.2022

Teleflex Medical SDN BHD

Basic endotracheal tube
Model: see FSN
Lot: see FSN

MD: Basic endotracheal tube, single-use

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

Vk_20221213_30

13.12.2022

Align Technology Inc.

Invisalign System

MD: Orthodontic progressive aligner

DE-1
FR-1
EN-1

Vk_20221209_24

13.12.2022

The Anspach Effort Inc.

Attachments - EM/XM
Model: CRANI-A; CRANI-A-01; CRANI-A-G1; CRANI-A-R; CRANI-L; CRANI-L-G1; CRANI-L-R; CRANI-P; CRANI-P-G1
S/N: all

G1 Attachments
Model: CRANI-L-G1; CRANI-L-R; CRANI-P; CRANI-P-G1
S/N: all

MD: Burring power tool attachment

MD: Trephining power tool attachment

EN-1

Vk_20221209_06

13.12.2022

Roche Diabetes Care GmbH

Accu-Chek Solo cannula assembly & pump holder
Model: 07858833001, 07858841001; 04015630881659, 04015630881642
Lot: 847468303 and lower

Accu-Chek Solo supply kit
Model: 07858817001, 07858825001; 04015630881666, 04015630881673
Lot: 847468303 and lower

MD: Kit For Continuous Subcutaneous Insulin Infusion

MD: Kit For Continuous Subcutaneous Insulin Infusion

DE-1
FR-1
IT-1

Vk_20221206_18

13.12.2022

Intersurgical Ltd

NEONATAL, NASAL CANNU WITH CURV PRON AND TUBE, 2.1M
Model: 1164000
Lot: see FSN

MD: Nasal oxygen cannula, basic

DE-1
IT-1

Vk_20221123_20

05.12.2022

(Updated 13.12.2022)

Philips Electronics Nederland B.V.

Philips Ingenia Elition
Model: 781357, 782106, 782137, 781358, 782107, 782119, 782136
S/N: see FSN

MD: Full-body MRI system, superconducting magnet

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

Vk_20221123_04

12.12.2022

DH HealthCare GmbH

ORBIS Medication
SW-Version: 3.16

MD: Patient health record information system application software

DE-1
EN-1

Vk_20221130_01

23.11.2022

(Updated 12.12.2022)

Leica Microsystems (Schweiz) AG

PROvido
Model: 10448950, 10448976
S/N: 91221002, 190122001, 290622001, 80822001, 101221002, 250122002

Leica M530 OHX
Model: 10448737, 10734920, 10745322
S/N: 121221001

PROVEO 8
Model: 10449039, 10449058, 10448808
S/N: 210122001, 310522001

MD: General-purpose surgical microscope

MD: Neurosurgical microscope

MD: Ophthalmic slit lamp, surgical

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

Vk_20221116_05

07.12.2022

FH INDUSTRIE

BEPOD MEASURING SCREWDRIVER
Model: 265788
Lot: SM46935

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1
FR-1
IT-1

Vk_20221130_05

16.11.2022

(Updated 07.12.2022)

Maquet Critical Care AB

Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
Model: 6888520, 6888530 , 6888540 , 6887700, 6887900
S/N: See FSN

MD: Anaesthesia workstation, general-purpose

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

Vk_20221107_02

06.12.2022

ICT Healthcare Technology Solutions B.V.

Mosos CTG
SW-Version: 12.15.04 up to and including 12.15.09

MD: Obstetrical monitoring/analysis software

FR-1

Vk_20221205_25

06.12.2022

ArcRoyal uc, an Owens and Minor Company

Ohr-Set- Custum procedure pack
Model: CPT 44-108443
Lot: 765744, 758780

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

DE-1
EN-1

Vk_20221205_19

06.12.2022

RaySearch Laboratories AB (publ)

RayStation
Model: 11A SP3, 11B SP3, 12A SP1
S/N: 11.0.4.15, 12.0.4.12, 13.1.0.144
SW-Version: 11A SP3, 11B SP3, 12A SP1

MD: Radiation therapy software

EN-1

Vk_20221205_18

06.12.2022

Beckman Coulter , Inc.

LeukoSure Enumeration Kit
Model: 175621
Lot: 5621089K, 5621090K

IVD: Leukocyte count kit

DE-1
IT-1
EN-1

Vk_20221130_20

06.12.2022

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
FR-1
EN-1

Vk_20221130_18

05.12.2022

Mizuho Orthopedic Systems, Inc

Levó Arm
Model: 7887-050; 7887-050
S/N: 507

MD: Conventional Remote Control Tables

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

Vk_20221129_03

05.12.2022

Siemens Healthcare GmbH

Axiom Iconos R100

Axiom Luminos TF

Iconos R200 C20_C

MD: Hand-held general-purpose fluoroscopic x-ray system, digital

MD: Hand-held general-purpose fluoroscopic x-ray system, analogue

MD: Orthosis, truncal/orthosis, limb

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

Vk_20221124_10

05.12.2022

Diatron MI Zrt

Diacon 3 hematology control (Normal)
Model: Diacon 3; 10031727
Lot: B1122N
S/N: N/A
SW-Version: N/A

IVD: Control bood multilevel

DE-1
EN-1

Vk_20221114_04

02.12.2022

Abbott Molecular Inc.

Alinity m Resp-4-Plex Amplification Reagent Kit
Model: 09N79-90
Lot: 525460, 526393, 531612, 525766, 526483, 527142, 527403, 527602, 381177

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

DE-1
FR-1
EN-1

Vk_20221125_13

01.12.2022

HeartWare Inc.

HeartWare Ventricular Assist System
Model: 1104, MCS1705PU
S/N: all

AIMD: Implantable ventricular circulatory assist system

DE-1
EN-1

Vk_20221129_08

01.12.2022

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

EN-1

Vk_20221124_25

01.12.2022

Elekta Nucletron B.V

Oncentra Brachy
Model: 170730
Lot: Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

MD: Radiation therapy software

DE-1
FR-1
EN-1

Vk_20221124_18

30.11.2022

Randox Laboratories Ltd

Randox Specific Protein Control Level 1, 2, 3
Model: PS2682, PS10221, PS2683, PS10222, PS2684, PS10223
Lot: See FSN
S/N: N/A
SW-Version: N/A

IVD: Multiple clinical chemistry protein IVD, control

EN-1

Vk_20221129_22

30.11.2022

X-Nav Technologies, LLC

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

MD: Surgical Navigation Instruments - Hardware Accessories

FR-1

Vk_20221124_06

24.11.2022

(Updated 30.11.2022)

CODAN pvb Critical Care GmbH

Druckmess-Set, 1-fach
Model: 74.7030
Lot: 977493

MD: Invasive Blood Pressure Monitoring Instruments

DE-1
FR-1
IT-1

Vk_20221124_02

22.11.2022

(Updated 30.11.2022)

Medtronic MiniMed

Guardian Connect Application
Model: MMT-8200, MMT-8201
S/N: all
SW-Version: 1.3.0

MD: Patient health record information system application software

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

Vk_20221121_33

30.11.2022

ConvaTec Limited

AQUACEL FOAM ADH Ag 10X10CM (1X10)
Model: REF 420681
Lot: 1C03858, 2A02626 and 2C03688

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

DE-1
FR-1
IT-1

Vk_20221115_01

30.11.2022

Ivoclar Vivadent AG

VivaPen Snap-On Cannulas
Model: 745763
Lot: All Batches

MD: Accessories / Non-medical device

DE-1
FR-1
IT-1

Vk_20221109_03

28.11.2022

Bard Access Systems Inc

Catheter Repair Kits
Model: Refer to the FSN
Lot: Refer to the FSN

MD: Catheter care kit

DE-1
EN-1

Vk_20221115_24

28.11.2022

Olympus Medical Systems Corp.

ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
Model: LTF-190-10-3D; N4501730, N4501750
S/N: All

MD: Rigid video laparoscope

DE-1

Vk_20221114_02

22.03.2022

(Updated 28.11.2022)

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

Vk_20220317_02

23.11.2022

(Updated 25.11.2022)

Siemens Healthcare Diagnostics Inc.

Atellica IM Free Prostate-Specific Antigen (fPSA)
Model: 10995577
Lot: see FSN
S/N: N/A

IVD: Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
EN-1

Vk_20221122_01

25.11.2022

Volcano Corporation

PV .035 Digital IVUS Catheter
Model: 88901
Lot: Product manufactured from 19.08.2021 to 28.02.2022

MD: Intravascular ultrasound imaging catheter, single-use

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

Vk_20221116_12

24.11.2022

Lohmann & Rauscher GmbH & Co. KG

Vliwaktiv Absorbent Activated Charcoal Dressing
Model: 20254, 20255
Lot: See FSN

MD: Odour-absorbent dressing, non-antimicrobial

DE-1
FR-1
IT-1

Vk_20221117_14

24.11.2022

VWR International

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

IVD: Fixative, formalin

DE-1
EN-1

Vk_20221109_13

21.11.2022

(Updated 24.11.2022)

Mobilex A/S

Arthritis rollator Tiger
Model: 312201+312202; 312201+312202
S/N: 2022060800051-00100 Model number 312202, 2022011100001-00050 Model number 312201, 2022022500001-00150 Model number 312201, 2022032100001-00070 Model number 312201, 2022041200001-00150 Model number 312201, 2021122200001-00050 Model number 312201

MD: Handgrip disability-assistive walker, non-powered, foldable

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

Vk_20221026_17

27.07.2022

(Updated 24.11.2022)

Abbott Medical

Assurity
Model: PM2152, PM2162, PM2172, PM2272
S/N: Subset of Assurity serial numbers

Endurity
Model: PM2152, PM2162, PM2172, PM2272
S/N: Subset of Endurity serial numbers

AIMD: Dual-chamber implantable pacemaker, rate-responsive

AIMD: Single-chamber implantable pacemaker, rate-responsive

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

Vk_20220720_23

23.11.2022

Ortho Clinical Diagnostics

VITROS Intact PTH Reagent and Calibrator
Model: 6802892
Lot: 1610, 1630, 1621, 1640, 1645, 1650, 1670
S/N: Not Applicable
SW-Version: Not applicable

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

EN-1

Vk_20221122_02

23.11.2022

Biomedical Data Solutions Limited

Ortho Connect
Model: 3.0; 6904413; 6904414; 6904415; 6913355; 6904410; 6904411; 6904412; 6993333; 6993332
SW-Version: 3.0

IVD: Laboratory instrument/analyser application software IVD

FR-1

Vk_20221121_02

15.11.2022

(Updated 23.11.2022)

bioMérieux SA

Various Laboratory Products
Model: See FSN
Lot: See FSN

IVD: Products with Time Temperature Out of Range Issue

DE-1-Clinical
DE-3-Industry
FR-1-Clinical
FR-2-Industry
EN-1-Clinical
EN-2-Industry

Vk_20221109_18

01.11.2022

(Updated 23.11.2022)

Olympus Europa SE & Co. KG

HF-resection electrode
Model: WA22602S, WA22603S, WA22621S, WA22657S; WA22602S, WA22603S, WA22621S, WA22657S
Lot: see FSN

MD: Electrodes, Electrosurgical

FR-1
EN-1

Vk_20221028_29

22.11.2022

GE Healthcare IITS USA Corporation

Centricity PACS-IW with Universal Viewer
SW-Version: 5.x, 6.x

MD: Medical image management system

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

Vk_20221118_09

22.11.2022

Siemens Healthcare GmbH

Sensis, Sensis Vibe Combo, Sensis Vibe Hemo
SW-Version: Sensis/Sensis Vibe systems with software version VD12A

MD: Cardiac catheterization laboratory computer

DE-1
FR-1
IT-1

Vk_20221117_03

22.11.2022

icotec ag

icotec Torque Wrench
Model: REF 42-702
S/N: 200221-038, 200221-046

MD: Neurosurgery And Spinal Surgery Instrument Kits, Reusable

DE-1

Vk_20221117_02

22.11.2022

Arrow International Inc

Arrow AutoCAT2 Intra-Aortic Balloon Pump
Model: see FSN
Lot: see FSN
S/N: N/A
SW-Version: N/A

Arrow AC3 Optimus Intra-Aortic Balloon Pump
Model: see FSN
Lot: see FSN

MD: Intra-aortic balloon pump

MD: Intra-aortic balloon pump

DE-1
FR-1
IT-1

Vk_20221117_01

22.11.2022

bioMérieux SA

VIDAS Anti-HEV IgM (HEVM)
Model: 418115
Lot: see FSN

IVD: Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20221116_14

22.11.2022

Peter Brehm GmbH

MRP-TITAN System
Model: see FSN
Lot: all

MD: Hip Prostheses Femoral Components

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

Vk_20221115_26

22.11.2022

Aesculap AG

SU TROCARS AND ACCESSORIES ; EK002SU

MD: Laparoscopic access cannula, single-use

EN-1

Vk_20221115_23

21.11.2022

Teleflex Medical

Ureteral Stent
Model: see FSN
Lot: see FSN

MD: Ureteral stent

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

Vk_20221109_04

17.11.2022

bess medizintechnik gmbh

aerstent TBJ
Model: TBJ; 533-18-040
Lot: 210061

MD: Bare-metal tracheal/bronchial stent, sterile

EN-1

Vk_20221018_14

16.11.2022

3M Company

3M Ranger Blood/Fluid Warming High Flow Sets
Model: 24355
Lot: HX9137, HX9158, HX9162, HX9167, HX9169, HX9179, HX9181, HX9183, HX9184, HX9189, HX9190, HX9192, HX9198, HX9200, HX9202, HX9204, HX9214

MD: Conduction blood/fluid warmer set

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

Vk_20221111_15

08.11.2022

(Updated 16.11.2022)

Drägerwerk AG & Co. KGaA

Polaris Multimedia
Model: G28994, G92759
S/N: All, see FSN

MD: Lights, Surgical

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

Vk_20221107_29

08.11.2022

(Updated 16.11.2022)

MAQUET Cardiopulmonary GmbH

PLS Set
Model: 701068386, 701068389, 701068390, 701076706
Lot: from 3000204268 to 3000272105, from 3000212851 to 3000270727, from 3000208694 to 3000227579, from 3000190149 to 3000252498

MD: Cardiopulmonary bypass system tubing set

DE-1
FR-1
EN-1

Vk_20221104_03

16.11.2022

BECTON DICKINSON INFUSION THERAPY AB

BD Connecta Stopcocks
Model: 394926, 394936, 394951, 394961, 394971
Lot: see FSN

MD: Intravenous line stopcock

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

Vk_20221028_03

15.11.2022

Belmont Instrument Corporation

CritiCool
Model: 200-00236
S/N: 9976535500001, 9975437700014, 9983349200008

MD: Controller, temperature

FR-1
EN-1

Vk_20221114_05

15.11.2022

Ventana Medical Systems, Inc

VENTANA PD-L1 (SP142) Assay
Model: 08008540001
Lot: see FSN
SW-Version: n/a

VENTANA PD-L1 (SP142) IHC Assay
Model: 07011571001
Lot: see FSN
SW-Version: n/a

IVD: Programmed death-ligand 1 (PD-L1) IVD, antibody

IVD: Programmed death-ligand 1 (PD-L1) IVD, antibody

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

Vk_20221114_03

06.09.2022

(Updated 15.11.2022)

Teleflex Medical SDN BHD

Iso-Gard Filter S
Model: 19012, 19012T, 191667-000100, 19211, 19212, 19261, 19272, 19261T, 19262T, 19272T, 19211T, 19212T
Lot: See FSN

Filter and Catheter Mount
Model: 191667-000100
Lot: See FSN

MD: Microbial medical gas filter, single-use

MD: Microbial medical gas filter, single-use

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

Vk_20220831_01

11.11.2022

MPS - Medizinische Planungssysteme GmbH

ChemoCompile
SW-Version: 1.56

MD: Information Systems, Data Management

DE-1

Vk_20221111_12

10.11.2022

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 and IMMULITE 2000 Xpi 3gAllergy Specific IgE Universal Kit
Model: 10380875 (600T)
Lot: 830

IVD: Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

FR-1

Vk_20221107_25

26.10.2022

(Updated 10.11.2022)

Iberhospitex, S.A.

DRENOFAST
Model: 0028470; 0028480

MD: Closed-wound drainage kit

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

Vk_20221010_11

09.11.2022

Getinge Disinfection AB

ED-FLOW, ED-FLOW SD
Model: ED-FLOW, ED-FLOW SD
S/N: All ED Flows manufactured since start 2010 until 2022-08-24

MD: Endoscope washer/disinfector

DE-1
EN-1

Vk_20221028_27

09.11.2022

Getinge Disinfection AB

ED-FLOW, ED-FLOW SD
Model: ED-FLOW, ED-FLOW SD
S/N: All ED Flows manufactured since start 2010 until 2022-08-24

MD: Endoscope washer/disinfector

DE-1
EN-1

Vk_20221028_24

09.11.2022

Mathys Ltd Bettlach

Straight cup positioner
Model: 51.34.1114
Lot: all

Curved cup positioner
Model: 51.34.1112
Lot: all

MD: Joint prosthesis implantation kit, reusable

MD: Joint prosthesis implantation kit, reusable

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

Vk_20221028_19

26.10.2022

(Updated 09.11.2022)

Huntleigh Healthcare

Sonicaid
Model: SF1-EUR
S/N: All manufactured devices

MD: Cardiotocography telemetric monitoring system

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

Vk_20221024_26

08.11.2022

Randox Laboratories Ltd

Randox IgM
Model: IM3834
Lot: see FSN

Randox IgA
Model: IA3832
Lot: see FSN

IVD: Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry

IVD: Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

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

Vk_20221103_13

08.11.2022

Sysmex Corporation

XQ-Series Automated Hematology Analyzer
Model: XQ-320; XQ-520
S/N: All

IVD: Haematology / Haemostasis / Immunohaemotology / Histology / Cytology Instruments

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

Vk_20221102_17

26.07.2021

(Updated 08.11.2022)

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

Vk_20210712_10

26.07.2021

(Updated 08.11.2022)

ACUTRONIC Medical Systems AG

fabian +nCPAP evolution
Model: 122001

Fabian HFO
Model: 111001, 111001.01, 112001, 113001

fabian Therapy evolution
Model: 121001

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_08

04.11.2022

Medacta International SA

NextAR Shoulder System
Model: various
Lot: all

MD: Optical surgical navigation device tracking system

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

Vk_20221024_32

04.11.2022

Leica Biosystems Newcastle Ltd

BOND RTU Primary Antibody Bcl-6
Model: PA0204
Lot: 72366

IVD: BOND tm Ready-to-Use Primary Antibody Bcl-6 (LN22)

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

Vk_20221020_05

27.10.2022

(Updated 04.11.2022)

EUROSPINE SARL

Metallic Cervical Interbody Fusion Cage
Model: HRCm4SD, HRCm5SD, HRCm6SD, HRCm7SD, HRCm5LD, HRCm4LD, HRCm5LD, HRCm6LD and HRCm7LD
Lot: 1825S and 1826S

MD: Polymeric spinal interbody fusion cage

FR-1
EN-1

Vk_20221017_23

10.08.2021

(Updated 04.11.2022)

Fresenius Kabi Deutschland GmbH

Exelia Combox
Model: Z086710
S/N: all

Exelia Therapy Manager
Model: Z086810
S/N: all

Exelia VP
Model: Z085010
S/N: all

MD: Bedside syringe pump

MD: Infusion pump management unit, mobile

MD: Bedside infusion pump, single-channel

FR-1
FR-2
FR-3

Vk_20210802_04

01.11.2022

The Binding Site Group Limited

Freelite Human Lambda Free Kit for use on the Siemens BN ProSpec
Model: LK018.P
Lot: 467939

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

DE-1
FR-1
EN-1

Vk_20221028_01

01.11.2022

TRACOE medical GmbH

TRACOE Tracheostomy tube
Model: see FSN
Lot: see FSN

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

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

Vk_20221027_09

01.11.2022

LOWTeq GmbH

LOWTeq PDMS
SW-Version: 7.24 and before

MD: Information Systems, Data Management

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

Vk_20221026_15

01.11.2022

BEAVER-VISITEC INTERNATIONAL, INC

BeaverArtho-LOK Pointed Tip Curve L 4mm Blade
Model: 376780
Lot: 6034831, 6039837

MD: Meniscus knife

DE-1
EN-1

Vk_20221014_17

28.01.2020

(Updated 01.11.2022)

Roche Diagnostics GmbH

Elecsys CA 19-9
Model: 07027028190
Lot: see FSN

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

DE-01
DE-02
DE-03
DE-04
DE-05
DE-06
DE-08
DE-09
DE-10
FR-01
FR-02
FR-03
FR-04
FR-05
FR-06
FR-08
FR-09
FR-10
IT-01
IT-02
IT-03
IT-04
IT-05
IT-06
IT-08
IT-09
IT-10
EN-01
EN-02
EN-03
EN-04
EN-05
EN-06
EN-07
EN-08
EN-09
EN-10

Vk_20200124_20

25.10.2022

(Updated 31.10.2022)

Abbott GmbH

Alinity m System
Model: 08N53-002
S/N: not serial specific

IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory

DE-1
FR-1
EN-1

Vk_20221021_15

31.10.2022

Visionsense Ltd

VS3 Iridium- MMS-IR
Model: 174-0012; 175-0012
S/N: 3784634, 3784711, 3784722, 3784656, 3784809; 3784803

VS3 Iridium - Light Integrator - Beamcombiner
Model: 161-0001
S/N: 3611026, 3611095, 3611169, 3611219

MD: Endoscope video camera

MD: Endoscope video camera

DE-1
FR-1
EN-1

Vk_20221020_06

17.10.2022

(Updated 31.10.2022)

Coloplast A/S

In-Ka Ureteral balloon dilatation catheter kit
Model: BD4144, BD4145, BD4146
Lot: see FSN
SW-Version: not applicable

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

DE-1
EN-1

Vk_20221005_09

21.10.2022

(Updated 28.10.2022)

REPROLIFE

Tissue Storage Plate (Warm Plate, Vitri Plate)
Model: VP010; WP010
S/N: All serial numbers released prior to 05 August 2022

MD: Tissue cryostorage straw

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

Vk_20221012_11

22.12.2020

(Updated 28.10.2022)

HeartWare Inc.

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

AIMD: Implantable ventricular circulatory assist system

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

Vk_20201218_18

30.07.2019

(Updated 28.10.2022)

Siemens Healthcare Diagnostics Products Limited

IMMULITE/IMMULITE 1000 Progesterone
Model: LKPW1
Lot: all

IMMULITE 2000/IMMULITE 2000 XPi Progesterone
Model: L2KPW2, L2KPW6
Lot: all

IVD: Progesterone IVD, kit, chemiluminescent immunoassay

IVD: Progesterone IVD, kit, chemiluminescent immunoassay

EN-1
EN-2
EN-3

Vk_20190723_14

27.10.2022

Cendres+Métaux SA

CM root canal posts Reamer (White) Post size 1
Model: 070243
Lot: 0000393156, 0000377328, 0000402740, 0000405797, 0000405800, 0000405801

MD: Reamers, Reusable

DE-1
FR-1

Vk_20221021_25

27.10.2022

(Updated 27.10.2022)

Biomet UK Ltd

G7 Acetabular System
Model: see FSN
Lot: see FSN

Avantage
Model: P0463046, P0463048, P0463052
Lot: see FSN

RingLoc-X
Model: EP-044060, EP-053268
Lot: see FSN

MD: Acetabular shell

MD: Non-constrained polyethylene acetabular liner

MD: Acetabular shell

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

Vk_20220928_02

11.08.2022

(Updated 27.10.2022)

Regen Lab SA

RegenKit-BCT Family
Model: A-CP-3, ACP-3 USA, A-CP-3-20, R-ACR C/BA, R-ACR C2/B, RK-BCT-1, RK-BCT-1 USA, RK-BCT-2A, RK-BCT-3, RK-BCT-3 USA, RK-BCT-T
Lot: see FSN

MD: Haematological concentrate system preparation kit, platelet concentration

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

Vk_20220804_10

18.10.2022

(Updated 26.10.2022)

Getinge - Maquet GmbH

Extension table top
Model: 114020AN, 114020F0; 114020AN, 114020F0
S/N: see FSN

MD: UMDNS=13-961

DE-1
EN-1

Vk_20221014_18

26.10.2022

Cardiac Pacemaker Inc

EMBLEM S-ICD
Model: A209
S/N: See FSN
SW-Version: Model 3877 v1.03 and 2877 v4.09

EMBLEM MRI S-ICD
Model: A219
S/N: See FSN
SW-Version: Model 3877 v1.03 and 2877 v4.09

AIMD: Single-chamber implantable defibrillator

MD: Subcutaneous Implantable Defibrillators

DE-1
FR-1
EN-1

Vk_20221003_13

25.10.2022

3M (Schweiz AG)

3M Steri-Drape Surgical Drapes
Model: 1000, 1010, 1020, 1021, 1030, 1033, 1060, 1061, 1061NS, 1071
Lot: see FSN

MD: Patient surgical drape, single-use

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

Vk_20221021_09

25.10.2022

Hamilton Medical AG

Hamilton-C6
Model: 160021

MD: Ventilators, Intensive Care

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

Vk_20220822_27

21.10.2022

Insulet Corporation

Omnipod DASH Personal Diabetes Manager (PDM)
Model: 18239; PT-000010, PT-000011, PT-000019-CHE-ITA, PT-000019-CHE-FRE, PT-000019-CHE-DEU
S/N: All serial numbers

MD: Ambulatory insulin infusion pump, electronic

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

Vk_20221012_13

21.10.2022

One Lambda Inc.

LinkSeq HLA Typing Kit
Model: See FSN
Lot: See FSN
SW-Version: SureTyper Software

IVD: HLA class I & II antigen tissue typing IVD, kit, multiplex

DE-1
FR-1
EN-2

Vk_20221004_17

02.06.2022

(Updated 20.10.2022)

Medtronic MiniMed

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

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

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

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

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

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

MD: Ambulatory insulin infusion pump, electronic

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

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

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

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

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

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

Vk_20220525_17

04.10.2022

(Updated 19.10.2022)

DiaMed GmbH

IH-500
Model: 001500 / 001500RECOND

IVD: Immunohaematology/blood bank analyser IVD

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

Vk_20220921_01

18.10.2022

Roche Diabetes Care GmbH

Accu-Chek Insight Flex Can. 8 10p A
Model: 06541810001
Lot: 1375604

MD: Kit For Continuous Subcutaneous Insulin Infusion

DE-1
FR-1
IT-1

Vk_20221018_15

17.10.2022

JIANGSU INTCO MEDICAL PRODUCTS Co., Ltd

Quickie
Model: Q50R
S/N: see separate list

MD: Wheelchair, attendant/occupant-driven, front-wheels-operated, collapsible

DE-1
EN-1

Vk_20220926_01

28.09.2022

(Updated 13.10.2022)

Life Technologies Corporation, a part of Thermo Fisher Scientific

TaqPath COVID-19 HT Kit
Model: A50883
Lot: not applicable

IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20220927_34

27.07.2022

(Updated 13.10.2022)

Etac A/S

Molift Air 350 and Air 350 Tilt
Model: Molift Air 350; M26350, M26351, M26352, M26353, M26355

Molift Air 500
Model: Molift Air 500; M26500

Molift Air 200
Model: Molift Air 200; M26200, M26200-00, M26201

Molift Air 205
Model: Molift Air 205; M25205, 25205-00, M25205-2, M26205, M26205-2, M27205

Molift Air 300
Model: Molift Air 300; M25300, M25300-2, M26300

MD: Overhead track patient lifting/transfer system

MD: Overhead track patient lifting/transfer system

MD: Overhead track patient lifting/transfer system

MD: Overhead track patient lifting/transfer system

MD: Overhead track patient lifting/transfer system

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

Vk_20220713_01

12.10.2022

Siemens Healthcare GmbH

Sensis Vibe Hemo
Model: 4056869010199; 11007641
S/N: 103759, 103764; 039-301915, 039-301912

MD: Cardiac catheterization laboratory computer

DE-1
EN-1

Vk_20221010_05

12.10.2022

CamDiab Ltd

mylife CamAPS
Model: FX
SW-Version: 1.4 (153) and all previous versions

MD: General Medicine Therapeutic Treatment Instruments - Software Accessories

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

Vk_20221006_02

04.10.2022

(Updated 12.10.2022)

Edwards Lifesciences LLC

Fogarty Fortis Arterial Embolectomy Catheter
Model: 120404FFP, 120804FFP
Lot: All lot numbers manufactured from October 2020 with VascuPouch packaging are impacted.

Fogarty Arterial Embolectomy Catheters Pouch-Pack
Model: 120803FP, 120404FP, 120403FP, 120804FP, 120806FP, 120602FP, 120805FP, 120807FP, 120803FSP, 120403FSP
Lot: All lot numbers manufactured from October 2020 with VascuPouch packaging are impacted.

Fogarty Biliary Balloon Probes - Pouch Pack
Model: 410235FP, 410236FP, 410405FP
Lot: All lot numbers manufactured from October 2020 with VascuPouch packaging are impacted.

MD: Thrombectomy balloon catheter

MD: Thrombectomy balloon catheter

MD: Biliary drain

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

Vk_20220928_09

27.09.2022

(Updated 12.10.2022)

Medtronic (Schweiz) AG

Synergy Cranial, StealthStation Cranial
Model: see FSN
Lot: see FSN

MD: Neurological stereotactic surgery system

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

Vk_20220915_16

09.08.2022

(Updated 12.10.2022)

Randox Laboratories Ltd

Randox Serology I Positive Control
Model: SR10352
Lot: 036SR

IVD: Multiple-type blood-borne pathogen antibody/antigen IVD, control

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

Vk_20220805_17

11.10.2022

B. Braun Surgical S. A.

GELITA-TAMPON
Model: 2070014; 2070103; 2070154; 2070600; 2070707

MD: Sponges, Scrub

DE-1
FR-1
EN-1

Vk_20221004_13

04.10.2022

(Updated 11.10.2022)

Covidien LLC

Endo Stitch V-Loc 180 Absorbable Reload
Model: see FSN
Lot: see FSN

Endo Stitch V-Loc PBT Non-Absorbable Reload
Model: see FSN
Lot: see FSN

MD: Barbed polyester suture, non-antimicrobial

MD: Polyester suture, non-bioabsorbable, monofilament

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

Vk_20220928_18

11.10.2022

DIABELOOP SA

DBLG1 and DBL-hu
Model: see FSN
SW-Version: 1.12.4

MD: Ambulatory insulin infusion pump/interstitial glucose monitoring system

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

Vk_20220927_11

04.10.2022

(Updated 10.10.2022)

bioMérieux

Mueller Hinton E Agar (MHE)
Model: See FSN
Lot: See FSN

IVD: Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

DE-1
FR-1
EN-2

Vk_20220928_19

05.10.2022

ZOLL Circulation, Inc.

AutoPulse
Model: Model 100; 8700-0752-01/02/04/08/11/16/20/27
Lot: N/A
S/N: Between 06530 and 13184 inclusive and shipped prior to 6/17/2022. Total no. of suspect batteries shipped to EU countries listed on this FSCA = 937

MD: Cardiac resuscitator, battery-powered

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

Vk_20220930_01

30.09.2022

(Updated 05.10.2022)

Medtronic MiniMed

MiniMed 670G Insulin Pump
Model: MMT-1761, MMT-1762, MMT-1781, MMT-1782

MiniMed 640G Insulin Pump
Model: MMT-1711, MMT-1712, MMT-1751, MMT-1752

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

MD: Ambulatory insulin infusion pump, electronic

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

Vk_20220922_07

05.10.2022

FertiPro NV

FertiCult Mineral Oil
Model: MINOIL500
Lot: FP21FM28

MD: Materials/solutions For Preparation/handling For Assisted Reproduction

EN-1

Vk_20220920_19

03.10.2022

Philips Medical Systems

MR Patient Care Portal 5000
Model: 453564792561
Lot: N/A
S/N: See UAL86201955A
SW-Version: 01.01.00 and 01.02.00

MD: General-purpose multi-parameter bedside monitor

DE-1_customer
DE-1_distributor
FR-1_customer
EN-1_customer

Vk_20220915_06

23.09.2022

(Updated 30.09.2022)

CareDx AB

Olerup QTYPE 11
Model: 201.701-03/10
Lot: E050; E051; E053; E054; E055; E056; E057; E058; E059; E060; E061

IVD: Hla Antigen Typing

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

Vk_20220923_18

27.09.2022

(Updated 29.09.2022)

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
FR-1
EN-1

Vk_20220921_10