Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2021 – 31.06.2021

MD: Stationary gamma camera system

EN-1

Vk_2021010

0.06.2021

Leica Biosystems Melbourne Pty Ltd

BOND-MAX
Model: 49.0051
S/N: see FSN

BOND-III
Model: 21.2201
S/N: see FSN

IVD: Microscope slide stainer IVD

IVD: Microscope slide stainer IVD

DE-1
EN-1

Vk_20210628_02

23.06.2021 

(Updated 30.06.2021)

Stago

STA-R Max
Model: All STA-R MAX references
S/N: All instruments on 4.06 software version
SW-Version: 4.06

IVD: Coagulation analyser IVD, laboratory, automated

DE-1
EN-1

Vk_20210618_07

29.06.2021

Medline International France SAS

QuickSuite
Model: DYND4060SBE, DYND4090SBE, QSS01, DYKQSUITEL2CEA, DYKQSUITEL2CEASB, DYKQSUITEL3CEA, DYKQSUITEL4CEA, DYKQS01, DYKQSC01
Lot: all
S/N: N/A
SW-Version: N/A

MD: Operating table sheet, single-use

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

Vk_20210628_28

29.06.2021

Fresenius Kabi Deutschland GmbH

Exelia SP

Exelia VP

Exelia Combox

MD: Syringe pump

MD: General-purpose infusion pump, line-powered

MD: Syringe pump

FR-1

Vk_20210628_03

29.06.2021

MY01 Inc.

MY01 Continuous Compartmental Pressure Monitor
Model: MY01-001
Lot: 9448532, 9448838, 9448979, 9449237

MD: Compartmental-pressure monitoring system, single-use

DE-1
FR-1
EN-1

Vk_20210625_17

29.06.2021

Lohmann & Rauscher GmbH & Co. KG

Gauze swabs with x-ray thread in Kitpack, SetPack
Model: see FSN
Lot: see FSN

MD: Woven gauze pad, sterile

DE-1
FR-1
EN-1

Vk_20210610_08

16.06.2021 

(Updated 23.06.2021)

Abbott

Activated Alanine Aminotransferase (A-ALT)
Model: 8L92-22; 8L92-42
Lot: see FSN

Alinity c Activated Alanine Aminotransferase Reagent Kit (A-ALT)
Model: 08P1820
Lot: see FSN

IVD: Alanine aminotransferase (ALT) IVD, reagent

IVD: Alanine aminotransferase (ALT) IVD, reagent

DE-1 (A-ALT)
DE-1 (Alinity c A-ALT)
FR-1 (A-ALT)
FR-1 (Alinity c A-ALT)
IT-1 (A-ALT)
IT-1 (Alinity c A-ALT)
EN-1 (A-ALT)
EN-1 (Alinity c A-ALT)

Vk_20210614_14

22.06.2021 

(Updated 23.06.2021)

BRAHMS GmbH, part of Thermo Fisher Scientific

B·R·A·H·M·S Solution 2 KRYPTOR GOLD
Model: 89992
Lot: Lot 854203, Lot 942551, Lot 189328, Lot 988902, Lot 230098, Lot 251292,
S/N: n.a.
SW-Version: n.a.

IVD: Buffered sample diluent IVD, automated/semi-automated system

DE-1
FR-1
EN-1

Vk_20210610_01

05.05.2021 

(Updated 22.06.2021)

GRUPPO BIOIMPIANTI SRL

Orthopedics Implantable Medical Devices
Model: see FSN
Lot: see FSN

MD: Several Orthopaedic Implantable Medical Device

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

Vk_20210429_07

16.06.2021 

(Updated 21.06.2021)

BioFire Diagnostics, LLC

BioFire FilmArray Pneumonia plus (PN plus) Panel
Model: RFIT-ASY-0142 and RFIT-ASY-0143
Lot: All product within 6 months of expiration

IVD: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
FR-1
EN-1

Vk_20210609_26

18.06.2021

Medtronic CoreValve LLC

CoreValve Evolut R Transcatheter Aortic Valve
Model: ENVEOR-L, ENVEOR-N
Lot: All manufactured products before 11 July 2020 and 1 additional lot 10281657
S/N: -

CoreValve Evolut PRO Transcatheter Aortic Valve
Model: ENVPRO-14, ENVPRO-16
Lot: All manufactured products before 11 July 2020 and 1 additional lot 10281657

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

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

DE-1
FR-1
IT-1

Vk_20210611_11

18.06.2021

Thermo Fisher Scientific Microbiology Basingstoke

AMC30 AMOXY/CLAV.ACID
Model: CT0223B
Lot: 2341375, 2343397, 2394162, 2403210, 2408058, 2438023, 2438086, 2457651, 2463120, 2464593, 2491412, 2511707, 2609976, 2832507, 2840771, 2935065, 2958576, 2968037, 2978564

IVD: Antimicrobial Susceptibility Test

DE-1
FR-1
IT-1

Vk_20210610_12

17.06.2021

Nevro Corp

S8 Lead Adaptor
Model: SADP2008-xx(B)

M8 Lead Adaptor
Model: MADP2008-xx(B)

AIMD: Stimulators, Electrical, Spinal Cord, Analgesic

AIMD: Stimulators, Electrical, Spinal Cord, Analgesic

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

Vk_20210601_13

26.05.2021 

(Updated 17.06.2021)

Delta Med s.r.l.

Intravenous catheters and accessories
Model: see FSN
Lot: see FSN
SW-Version: Non applicabile

MD: Intravenous catheters and accessories

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

Vk_20210525_02

16.06.2021

GE Medical Systems Information Technologies, Inc.

CASE / CardioSoft Cardiac Testing System
SW-Version: V6.6x, V6.7x, V7.0

MD: Cardiac stress exercise monitoring system

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

Vk_20210614_08

16.06.2021

CareDx AB

Olerup QTYPE 11
Model: 201.701-10
Lot: E047
S/N: N/A
SW-Version: N/A

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

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

Vk_20210614_05

10.06.2021 

(Updated 16.06.2021)

Boddingtons

Endocuff Vision
Model: ARV110 ENDOCUFF-V M BLUE PK8 & ARV120 ENDOCUFF-V L GREEN PK8 & ARV130 ENDOCUFF-V S PURPLE PK8 & ARV140 ENDOCUFF-V XL ORANGE PK8; E0420501 (ARV110) & E0420500 (ARV120) & E0420502 (ARV130) & E0420503 (ARV140)
Lot: see FSN
SW-Version: N/A

MD: Endoscope tissue removal cap, single-use

DE-1
FR-1
EN-1

Vk_20210610_19

16.06.2021

Philips/Respironics, Inc

CPAP Breathing Systems
SW-Version: Not Applicable

MD: Ventilator breathing circuit, single-use

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

Vk_20210610_16

16.06.2021

CeMed GmbH

Innova-Set

MD: Casework, Multipurpose

DE-1
FR-1

Vk_20210601_15

15.06.2021

Medline International France SAS

Flexible light handle cover
Model: FLHC1 & FLHC2
Lot: All Lot numbers

MD: Medical equipment handle cover, single-use, sterile

FR-1
EN-1

Vk_20210614_02

15.06.2021

G.T.A. S.r.l.

Biopsy Needle
Model: PAG 1820
Lot: GT0056/20, GT0151/20, GT0152/20, GT0227/20

MD: Needles

EN-DE-1

Vk_20210602_20

14.06.2021

Ethicon Endo-Surgery LLC

Powered Plus Articulating Endoscopic Linear Cutter
Model: PSEE60A; LSR194P
Lot: U94V47; 10215411, 10215399, 10215407, 10215404
SW-Version: N/A

MD: Endoscopic motorized cutting stapler, single-use

DE-1
EN-1

Vk_20210603_23

10.06.2021

Philips/Respironics, Inc

Trilogy 100
S/N: see FSN

Trilogy 200
S/N: see FSN

BiPAP Hybrid A30, BiPAP V30 Auto, BiPAP A30 / A40
S/N: see FSN

MD: Ventilator

MD: Ventilator

MD: Portable electric ventilator

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

Vk_20210610_14

10.06.2021

bioMérieux SA

Sabouraud 2 agar (SAB2-T)
Model: 42037
Lot: 1008262940 - Expiry date: 01-MAR-2022, 1008342620 - Expiry date: 13-APR-2022, 1008472120 - Expiry date: 14-JUL-2022, 1008545830 - Expiry date: 04-AUG-2022, 1008615520 - Expiry date: 15-SEPT-2022

IVD: Basic/simple nutrient agar culture medium IVD

DE-1

Vk_20210526_22

10.06.2021

Siemens AG Healthcare

ARTIS ZEE CEILING
Model: see enclosure; see enclosure
S/N: Artis zee ceiling-Systeme, ------------------------, Artis zee ceiling systems

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20210322_28

09.06.2021

Philips Medical Systems Nederland BV

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Monitor Bracket Assembly
Lot: NA
SW-Version: NA

MD: Custom-made medical device mount

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

Vk_20210603_25

06.05.2021 

(Updated 09.06.2021)

Covidien LLC

Covidien DAR airway products
Model: see FSN
Lot: see FSN

MD: Breathing circuits, filters, suction catheters

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

Vk_20210426_14

29.12.2020 

(Updated 09.06.2021)

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

Vk_20201228_03

08.06.2021

Datex Ohmeda

Carestation 750, Carestation 750c
Model: 1012-9750-000, 1012-9755-000
S/N: See appendix attached to customer letter for list of affected serial numbers

MD: Anaesthesia workstation, general-purpose

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

Vk_20210603_22

08.06.2021

Contura International A/S

Bulkamid Urethral Bulking System
Model: 50012
Lot: see FSN

MD: Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

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

Vk_20210531_13

01.06.2021 

(Updated 08.06.2021)

Hillrom

Affinity IV Birthing Bed
Model: P3700B, P3700C, P3700D, P3700E

MD: Birthing bed/table, powered

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

Vk_20210527_06

07.06.2021

Cerus Corporation

INTERCEPT Processing Set for Plasma Units
Model: see FSN
Lot: All batches produced since June 2019

MD: Plasma photochemical treatment kit

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

Vk_20210528_10

04.06.2021

Siemens Healthcare GmbH

Artis pheno
S/N: Artis pheno systems with SW VE10B
SW-Version: VE10B

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20210527_18

02.06.2021 

(Updated 04.06.2021)

Siemens Healthcare Diagnostics Inc

Atellica UAS 800 Analyzer
Model: 11065004
Lot: n/a
S/N: All
SW-Version: Up to and incl. V4.0.310

Atellica 1500 Automated Urinalysis System
Model: 11065004
Lot: n/a
S/N: All
SW-Version: Up to and incl. V4.0.310

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

DE-1
FR-1
EN-1

Vk_20210525_44

04.06.2021

Lagis Enterprise Co., Ltd.

Endoscopic Instruments Scissors - Metzenbaum Curve
Model: El-3305
Lot: see FSN

MD: Flexible endoscopic scissors, single-use

DE-1
FR-1
EN-1

Vk_20210520_22

03.06.2021

Cardiac Pacemaker Inc

INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps)
Model: see FSN
S/N: see FSN

AIMD: Pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)

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

Vk_20210603_04

01.06.2021 

(Updated 03.06.2021)

XENIOS AG

support.set infant IPS (DP3, hilite 800LT, Rheopar
Model: 30000396; F30000396
Lot: 210310M653, 210222M403, 200923M554, 200728M087, 200722M875, 200515M499, 200428M445, 200324M785, 200326M094, 200316M033, 200219M250, 200123M038, 200121M642, 191219M773, 191028M748, 191007M255, 190917M897, 190917M858, 190916M734

MD: Cardiopulmonary bypass system tubing set

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

Vk_20210531_09

22.02.2021 

(Updated 03.06.2021)

Medtronic Inc.

Valiant NavionTM Thoracic Stent Graft System
Model: All
Lot: All
S/N: -
SW-Version: N/A

MD: Descending thoracic aorta endovascular stent-graft

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

Vk_20210218_20

18.09.2018 

(Updated 03.06.2021)

Cardiac Pacemaker Inc

ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 pacemakers and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)
Model: ACCOLADE: L300, L301, L310, L311, L321, L331; PROPONENT: L200, L201, L209, L210, L211, L221, L231; ESSENTIO: L100, L101, L110, L111, L121, L131; ALTRUA 2: S701, S702, S722; VISIONIST CRT-P: U225, U226, U228; VALITUDE CRT-P: U125, U128
S/N: see FSN

AIMD: Pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)

DE-1a
DE-1b
DE-2
FR-1b
FR-2
IT-1a
IT-1b
IT-2
EN-1a
EN-1b
EN-2

Vk_20180911_13

02.06.2021

Cytocell Ltd

DiGeorge/VCFS TUPLE1 and 22q13.3 Deletion Probe
Model: LPU004
Lot: 070180, 070626, 071116 and 073304

IVD: DiGeorge syndrome IVD, probe

DE-1
FR-1
IT-1

Vk_20210531_02

01.06.2021

Richard Wolf GmbH

MOTOR CONTROL UNIT 2307
Model: see FSN

MD: Tissue morcellation system

DE-1
FR-1
IT-1

Vk_20210531_12

01.06.2021

Hell & Co GmbH

Customized sets & treatment units
Model: see FSN
Lot: see FSN

MD: Casework, Multipurpose

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

Vk_20210528_13

01.06.2021

Össur hf

Miami J Select
Model: MJS-101, MJSR-101
Lot: MX180425 to MX200306

MD: Cervical spine collar, reusable

DE-1
FR-1
IT-1

Vk_20210526_08

01.06.2021

Beckman Coulter Ireland, Inc.

Creatine Kinase - MB (CK-MB)
Model: OSR6x155
Lot: All Lots
S/N: n/a

IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, enzyme spectrophotometry

DE-1

Vk_20210525_42

01.06.2021

Delta Med s.r.l.

Vasodrop Safety
Model: see FSN
Lot: see FSN

MD: Vasodrop Safety, Mandrin fü r Vasodrop Safety

DE-1
FR-1
IT-1

Vk_20210519_07

26.05.2021 

(Updated 31.05.2021)

M.E.D. Medical Products GmbH

Sterile customer kits containing BD components
Model: see FSN
Lot: see FSN

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

DE-1
FR-1
EN-1

Vk_20210517_49

28.05.2021

Institut Straumann AG

SCS Screw driver for Ratchet
Model: 046.401; 046.402
Lot: 046.401 Lot EHG85; 046.402 Lot FAP78
SW-Version: n/a

MD: Surgical screwdriver, reusable

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

Vk_20210520_21

05.05.2021 

(Updated 28.05.2021)

Bausch & Lomb Inc.

ReNu, Boston, Biotrue, EasySept, Sensitive Eyes contact lense solutions, Ophtaxia eye wash solution
Model: see FSN
Lot: see FSN

MD: Contact Lens Rinsing/Cleaning/Care Solution/Eye Wash Solution

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

Vk_20210505_04

27.05.2021

Bionic Medizintechnik GmbH

Führungsdraht mit J- förmiger Spitze
Lot: 201211

MD: Guide Wire

DE-1

Vk_20210520_11

28.06.2018 

(Updated 27.05.2021)

Radiometer Medical ApS

ABL800
Model: 393-801
S/N: all

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

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_20180622_08

26.05.2021

The Binding Site Group Limited

Freelite Human Kappa Free Kit on Roche Cobas
Model: LK016.CB; LK016.10CB
Lot: LK016.CB - 487719, 480133 and 457890; LK016.10CB - 457891

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

DE-1
FR-1
EN-1

Vk_20210525_01

26.05.2021

Siemens Healthcare GmbH, HC SV DS,

syngo.via
Model: 11461857
SW-Version: VB50A / VB50B

MD: Radiology DICOM image processing application software

DE-1
FR-1

Vk_20210521_13

26.05.2021

Philips Medical Systems Nederland BV

Ingenia Ambition X
Model: 871356, 871359; NAQ

MD: Full-body MRI system, superconducting magnet

DE-1
FR-1
EN-1

Vk_20210520_29

26.05.2021

BD Becton Dickinson Infusion Therapy AB

BD Venflon Pro I.V. Cannula
Model: 393210, 393209, 393208, 393207, 393206, 393204, 393202

MD: Peripheral intravenous cannula

DE-1
FR-1
EN-1

Vk_20210519_15

25.05.2021

Terumo Europe N.V.

Terumo Extracorporeal blood circuits, Tubing sets
Model: CX-BE068X, CX-BE093X, CX-BE094X, CX-CH088X, CX-CH094X, CX-CH132X, CX-CZ095XA, CX-CZ095X, CX-CZ096X, CX-DK098, CX-GE279, CX-UK484, CX-UK575; CX-BE068X, CX-BE093X, CX-BE094X, CX-CH088X, CX-CH094X, CX-CH132X, CX-CZ095XA, CX-CZ095X, CX-CZ096X, CX-DK098, CX-GE2
Lot: 1905120, 1908484, 2005151, 2005317, 1903203, 1904220, 1905362, 1907097, 1903126, 1903442, 1904341, 2004273, 1903224, 1904103, 1905398, 1904100, 1905104, 1906111, 1908344, 2004157, 2005231, 2005305, 1904375, 1904377, 1908370, 1908371, 2004022, 2004197, 200

MD: Cardiopulmonary bypass system tubing set

DE-1
EN-1

Vk_20210525_43

25.05.2021

Randox Laboratories Ltd

Randox NEFA (Non-esterified fatty acid)
Model: FA115
Lot: 544642

IVD: Non-esterified fatty acid IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20210520_25

25.05.2021

Karl Storz SE & Co.KG

Filter, Insufflation
Model: 031122-25
Lot: see FSN

MD: Microbial medical gas filter, sterile, single-use

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

Vk_20210520_12

25.05.2021

Angiomed GmbH & Co. Medizintechnik KG

Venovo Venous Stent System
Model: See FSN
Lot: All unexpired product

MD: Iliofemoral vein stent

DE-1
FR-1
EN-1

Vk_20210520_01

25.05.2021

Laboratorium Dr. G. Bichsel AG

Kaliumzusatzlösung für Hämodialysekonzentrate
Model: PPF 54 ml; FE1010067
Lot: L201714
SW-Version: n.a.

MD: Dialysate, hemodialysis

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

Vk_20210518_20

11.05.2021 

(Updated 25.05.2021)

Johnson & Johnson Vision Care

ACUVUE Vita
Lot: B00WWWL

MD: Soft corrective contact lens, daily-wear

DE-1
FR-1
EN-1

Vk_20210506_04

21.05.2021

BIOPSYBELL S.R.L.

Cement delivery cannula Ø1, 8mm, length 273mm
Model: SM-SF0927
Lot: 19123119

MD: Orthopaedic cement preparation/delivery kit

DE-1

Vk_20210517_57

21.05.2021

MAQUET Cardiopulmonary GmbH

Combination of Neonatal Venous Hardshell Cardiotomy Reservoir with QUADROX-I Neonatal Oxygenator with or without coating, Neonatal Venous Hardshell Cardiotomy Reservoir
Model: 701048596, 701051430, 701054173, 701050109, 701053443, 701049279, 701053444, 701063847, 701070440, 701070444, 701071077
SW-Version: N/A

MD: Cardiotomy reservoir

DE-1
FR-1

Vk_20210511_08

20.05.2021

BY CONNIEHANSEN 2015 ApS

Petra, Cross Runner, X STRONG
Model: 15013-4, 15013-5, 10008-4, 10008-5, 10016-4, 10016-5
S/N: 2001001 - 2103087

MD: Foot-propelled tricycles

DE-1
FR-1
IT-1

Vk_20210420_24

19.05.2021

Hell & Co. GmbH Medical Devices

Customized sets & treatment units
Model: see FSN
Lot: see FSN

MD: Casework, Multipurpose

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

Vk_20210517_47

19.05.2021

LeMaitre Vascular, Inc.

LeMaitre Aortic Occlusion Catheter
Model: 2107-80, 2107-81
Lot: see FSN

MD: Intravascular occluding balloon catheter, image-guided

DE-1
FR-1
IT-1

Vk_20210517_23

19.05.2021

Terumo Cardiovascular Systems

Terumo Sarns TCM II Cooling and Heating System

MD: Cardiopulmonary bypass system heating/cooling unit

FR-1

Vk_20210512_45

19.05.2021

Kulzer GmbH

PalaXtreme
Model: Liquid & Powder; several catalogue numbers
Lot: several

MD: Materials For The Preparation Of Custom-made Dental Devices - Other

DE-1
FR-1
IT-1

Vk_20210507_02

12.05.2021 

(Updated 19.05.2021)

C.G.M. SPA divisione medicale META

Sterile blade for use as a cutting device in surgi
Model: see FSN
Lot: see FSN

MD: Manual scalpel blade, single-use

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

Vk_20210504_12

18.05.2021

Karl Storz SE & Co.KG

Video Mediastinoscope
Model: 10973HD
S/N: ALL

MD: Rigid mediastinoscope

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

Vk_20210517_35

18.05.2021

Telemis

Telemis-Medical
SW-Version: All versions 4.95

MD: Radiological PACS software

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

Vk_20210517_19

18.05.2021

Maquet Critical Care AB

SoKINOX / SERViNO
Model: SoKINOX / SERViNO NO delivery system; 66 94 550 / 68 81 700

MD: Nitric oxide delivery unit, system-based

DE-1
FR-1
EN-1

Vk_20210512_35

12.05.2021 

(Updated 18.05.2021)

NeuMoDx Molecular, a QIAGEN Company

NeuMoDx Cartridge
Model: 100100
Lot: 106629, 106630, 106631, 106632 used in conjunction with either of the following assays: - NeuMoDx SARS CoV-2 Test Strip (REF 300800) - NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900)
S/N: All
SW-Version: N/A

IVD: Microplate IVD

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

Vk_20210512_20

12.05.2021 

(Updated 18.05.2021)

Bosch Healthcare Solutions GmbH

Vivalytic SARS-CoV-2 and SARS-CoV-2 Pooling
Model: F09G 300 411, F09G 300 587

IVD: SARS-CoV-2 test

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

Vk_20210510_40

18.05.2021

Leica Biosystems Newcastle Ltd

BOND Wash Solution 10X Concentrate
Model: AR9590
Lot: W120976, W121328, W121440, W121585, W121996, W122202, W122370, W122860, W123000, W123403

BOND Epitope Retrieval Solution 1
Model: AR9961
Lot: ER1120817, ER1121284, ER1121584, ER1121849, ER1121997, ER1122204, ER1122368, ER1122369, ER1122723, ER1122996, ER1123064, ER1123377, ER1120284

BOND Epitope Retrieval Solution 2
Model: AR9640
Lot: ER2120585, ER2120977, ER2121181, ER2121327, ER2121498, ER2121586, ER2121848, ER2121994, ER2122029, ER2122200, ER2122366, ER2122477, ER2122543, ER2122858, ER2122859, ER2122999, ER2123166, ER2123302, ER2123460, ER2120286

IVD: Buffered wash solution IVD, automated/semi-automated system

IVD: Immunohistochemistry antigen retrieval reagent IVD

IVD: Immunohistochemistry antigen retrieval reagent IVD

DE-1
FR-1
IT-1

Vk_20210510_34

18.05.2021

Limacorporate S.p.a.

Multigen Plus H knee system
Model: all Multigen Plus H components

MD: Knee prosthesis, internal, total

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

Vk_20210510_04

11.05.2021 

(Updated 18.05.2021)

Siemens Healthcare Diagnostics Inc

Atellica CH 930 Analyzer
Model: Atellica CH 930 Analyzer; 11067000
SW-Version: Software versions 1.24.0 SP1 and lower

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1
FR-1
EN-1

Vk_20210507_08

11.05.2021 

(Updated 18.05.2021)

AIR LIQUIDE MEDICAL SYSTEMS

WALL CHARGING STATION for MONNAL T60
Model: KA010300
S/N: All

MD: General utility supply system, wall-mounted

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

Vk_20210504_04

26.01.2021 

(Updated 18.05.2021)

Baxter Healthcare SA

PrisMax, V2, ROW
Model: 955558
S/N: all

MD: Haemodialysis system, institutional

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

Vk_20210118_24

05.08.2020 

(Updated 18.05.2021)

Siemens Healthcare Diagnostics Inc

Dimension EXL High Sensitivity Troponin I Flex
Model: 10471068
Lot: EB0255

Dimension Vista High Sensitivity Troponin I Flex
Model: 10471067
Lot: 20008BB, 20035BC, 20135BB

IVD: Troponin I IVD, kit, chemiluminescent immunoassay

IVD: Troponin I IVD, kit, chemiluminescent immunoassay

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_20200730_06

27.06.2019 

(Updated 18.05.2021)

Datascope Corp.

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

MD: Intra-aortic balloon pump

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

Vk_20190619_15

17.05.2021

Löwenstein Medical Innovation GmbH & Co. KG

Intensive Care Ventilators elisa 300, elisa 500, elisa 600, elisa 800 and elisa 800VIT
SW-Version: 2.02.x, 2.04.0, 2.04.1, 2.04.2 und 2.05.x

MD: Intensive care ventilator

DE-1
EN-1

Vk_20210504_13

04.05.2021 

(Updated 17.05.2021)

ViewRay Inc.

Stereotactic radiotherapy/MRI System
Model: MRIdian Linac System; 20000-1
S/N: 108, 203, 214, 215, 226, 228, 232, 240 and 244

MD: Stereotactic teletherapy radionuclide system, MRI-imaging

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

Vk_20210503_01

06.05.2021 

(Updated 17.05.2021)

Synaptive Medical Inc

Synaptive Trackable Suction
Model: All versions; SYN-0657 and SYN-0783
Lot: All lot/batch numbers are affected.
S/N: All serial numbers are affected.
SW-Version: N/A

MD: Suction cannula, reusable

FR-1
EN-1

Vk_20210428_23

20.04.2021 

(Updated 17.05.2021)

Roche Diagnostics GmbH

IRON 2
Model: 03183696122
Lot: All

IVD: Iron IVD, kit, spectrophotometry

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

Vk_20210413_16

14.05.2021

Sidam s.r.l. a Socio Unico

SIDAM, 8 INCH, EXTENSION, W/VALVE
Model: see FSN
Lot: see FSN

MD: W/VALVE

DE-1
FR-1
IT-1

Vk_20210409_21

12.05.2021

Becton Dickinson GmbH

Group B Streptococcus Differential Agar (Granada)
Model: 257079
Lot: 1056185, 1057448, 1069181, 1083771

IVD: Group B Streptococcus Differential Agar

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

Vk_20210510_38

12.05.2021

M.D.L. SRL

Biopsy Needle
Model: PB2315, PC01615, PS1310
Lot: 1718, 3818, 0618

Needle for regional anaesthesia
Model: AETM21090
Lot: 0118

MD: Needles

MD: Needles

IT-/EN1

Vk_20210505_01

12.05.2021

CeramOptec GmbH

FiLaC Fistula Kit
Lot: 18A022I 19D013I 19F027I 20K008I 18B015I 19D014I 19I010I 20K009I 18G011I 19E008I 20B008I 20L001I 19A003I 20C007I 18G007I 19C002I 19F002I 18J002I

LHP Procedure Kit
Lot: 18A022I 19D013I 19F027I 20K008I 18B015I 19D014I 19I010I 20K009I 18G011I 19E008I 20B008I 20L001I 19A003I 20C007I 18G007I 19C002I 19F002I 18J002I

HeLP Procedure Kit
Lot: 18A022I 19D013I 19F027I 20K008I 18B015I 19D014I 19I010I 20K009I 18G011I 19E008I 20B008I 20L001I 19A003I 20C007I 18G007I 19C002I 19F002I 18J002I

MD: General/multiple surgical laser system beam guide, single-use

MD: General/multiple surgical laser system beam guide, single-use

MD: General/multiple surgical laser system beam guide, single-use

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

Vk_20210504_14

04.05.2021 

(Updated 12.05.2021)

TRUSETAL VERBANDSTOFFWERK GMBH

TRU-PACK surgical procedure kits
Model: see FSN
Lot: see FSN

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

DE-1
DE-2
FR-1

Vk_20210426_24

24.03.2021 

(Updated 12.05.2021)

Diffuplast srl

Parenteral, Enteral nutrition bags, Connection set, Filling set, Transfer sets, Preparation sets, Extension sets
Model: see FSN
Lot: see FSN

MD: Intravenous administration bag/bottle

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

Vk_20210302_16

04.05.2021 

(Updated 11.05.2021)

Teleflex Malaysia

Rüschelit Super Safety Clear Tracheal Tube
Model: see FSN
Lot: see FSN

MD: Basic endotracheal tube, single-use

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

Vk_20210503_10

28.04.2021 

(Updated 11.05.2021)

Servoprax GmbH

Mediware Infusionsgerät
Model: H7 0303
Lot: see FSN

MD: Intravenous Administration Sets

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

Vk_20210426_20

27.04.2021 

(Updated 11.05.2021)

Quanta System SpA

Sterile Optical Fibers reusable
Model: see FSN
Lot: see FSN

Steril Optical Fibers single use
Model: see FSN
Lot: see FSN

MD: Urogenital surgical laser system beam guide, reusable

MD: Urogenital surgical laser system beam guide, single-use

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

Vk_20210419_17

11.05.2021

Baxter Healthcare SA

Access Sets, Reconstitution Devices and Nutrition Devices
Model: see FSN
Lot: All batches within expiry that have been sterilized at Steril Milano.

MD: Surgical irrigation tubing set, single-use, Intravenous fluid container single-use, Intravenous administration tubing extension set, Medical tubing clip/clamp, dial-calibrated, Peritoneal dialysis system tubing set, Blood transfusion set

DE-1
FR-1
IT-1

Vk_20210322_02

10.05.2021

ITP Innovative Tomography Products

Koaxiale interventionelle Kanüle 21Gx150
Lot: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820

MD: Koaxiale interventionelle Kanü le

FR-1
IT-1
EN-1

Vk_20210429_03

10.05.2021

SAPI MED S.p.A.

SAPI MED
Model: see list
Lot: see list

MD: sterile coloproctology products

DE-1
FR-1
IT-1
EN-product list

Vk_20210428_22

12.04.2021

SOMATEX Medical Technologies GmbH

Bone Marrow
Model: 180910, 180935, 180960, 180965
Lot: see FSN

MR Safe Cut
Model: 601210
Lot: see FSN

Marrow Cut
Model: 180980, 180990, 180995
Lot: see FSN

SAFE-CUT
Model: 181130, 181140, 181145
Lot: see FSN

MD: Biopsy needle, general-purpose, single-use

MD: Biopsy needle, general-purpose, single-use

MD: Biopsy needle, general-purpose, single-use

MD: Biopsy needle, general-purpose, single-use

DE-1
IT-1
EN-1

Vk_20210330_11

07.05.2021

Covidien LLC

Signia small diameter curved intelligent reload
Model: SIGSDS30CTV, SIGSDS30CTVT, SIGSDL45CTVT
Lot: see FSN
S/N: n/a

MD: Surgical staple loading unit, non-cutting

EN-1

Vk_20210329_11

06.05.2021 

(Updated 06.05.2021)

ACE Medical Co. Ltd

AutoSelector
Model: AFLC-B
Lot: A200804-PSCFB000CH-1, A200805-PSCFB000CH-1

MD: Elastomeric infusion pump system

DE-1
EN-1

Vk_20210430_13

05.05.2021

bioMérieux SA

Sabouraud 2 agar (SAB2-T)
Model: 42037
Lot: 1007856360 - Expiry date: 28-APR-2021, 1007724190 - Expiry date: 18-MAY-2021, 1008001290 - Expiry date: 03-OCT-2021, 1008112720 - Expiry date: 06-DEC-2021
S/N: N/A
SW-Version: N/A

IVD: Basic/simple nutrient agar culture medium IVD

DE-1

Vk_20210428_24

03.05.2021 

(Updated 05.05.2021)

Fuji Systems Corporation, Shirakawa Plant

Sterilized Drape for PDE
Model: 0823802
Lot: ALL

MD: Instrument/equipment drape, single-use, sterile

DE-1
EN-1

Vk_20210406_01

09.03.2021 

(Updated 05.05.2021)

BECTON DICKINSON INFUSION THERAPY AB

BD Venflon Pro Safety I.V. Cannula
Model: see FSN
Lot: see FSN

MD: Peripheral intravenous cannula

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

Vk_20210218_17

04.05.2021

HEMODIA SAS

PATIENT SET W/ C-VALVE DF PUMP
Model: 11010077
Lot: 1137483
S/N: NA
SW-Version: NA

MD: Surgical irrigation tubing set, single-use

DE-1
FR-1
IT-1

Vk_20210503_05

04.05.2021

Soluscope SAS

SOLUSCOPE SERIE 4 PA
Model: SL-V4-PA
SW-Version: 1.8.2

MD: Flexible endoscope washer

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

Vk_20210430_22

04.05.2021

Medtronic Sofamor Danek USA, Inc.

Break-off set screw
Model: 777501000
Lot: CT20L012, CT20L020

MD: Bone-screw internal spinal fixation system, sterile

FR-1
EN-1

Vk_20210428_03

23.04.2021 

(Updated 04.05.2021)

ACUTRONIC Medical Systems AG

fabian +nCPAP evolution
Model: 7050.IB, 122001, 7250.IB/122011, 122012
S/N: see FSN

Fabian HFO
Model: 111001, 111001.01, 112001, 113001
S/N: see FSN

fabian Therapy evolution
Model: 121001, 121012
S/N: see FSN

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

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

Vk_20210419_06

13.04.2021 

(Updated 04.05.2021)

Datascope Corp.

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

MD: Intra-aortic balloon pump

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

Vk_20210407_14

23.02.2021 

(Updated 04.05.2021)

Immucor GTI Diagnostics, Inc.

MatchIt! DNA Software
Model: 888623; 888623CE
SW-Version: V1.2 and V1.3

IVD: MatchIt! DNA Software

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

Vk_20210218_06

27.04.2021 

(Updated 03.05.2021)

Coloplast A/S

Philips bougie female metric thread
Model: AG5416, AG5420
Lot: 7694143 (cat. AG5416), 7748119 (cat. AG5420)

MD: Urethral bougie, single-use

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

Vk_20210422_14

03.05.2021

Boston Scientific Corporation

POLARSHEATH
Model: M004CRBS3050, POLARSHEATH Steerable Sheath 12F
Lot: all, first lot put on the market: 11-DEC-2019

MD: Vascular guide-catheter, single-use

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

Vk_20210413_13

27.04.2021 

(Updated 30.04.2021)

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur XP / XPT / CP

ADVIA Centaur Syphilis
Model: 10492493
Lot: All Lots

IVD: Chemistry / Immunochemistry Instruments

IVD: Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

FR-1
EN-1

Vk_20210423_10

30.04.2021

Welch Allyn Inc

ProBP 3400 Blood Pressure Device
Model: 34XFHT-B
S/N: All

GS 777 Wall Transformer
Model: 77710
S/N: All

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

MD: Basic power supply

DE-1
FR-1
IT-1

Vk_20210419_25

19.08.2020 

(Updated 30.04.2021)

Ortho Clinical Diagnostics

ORTHO VISION Analyser
Model: 6904579

ORTHO VISION Max Analyzer
Model: 6904578

IVD: Blood group/antibody screening analyser IVD, automated

IVD: Blood group/antibody screening analyser IVD, automated

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

Vk_20200817_27

22.04.2021 

(Updated 29.04.2021)

ArjoHuntleigh AB

Nimbus 4 & Nimbus Professional
Model: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P; n/a
Lot: n/a
S/N: 13 042 mattresses manufactured between 09-Sep-2013 and 2021-Mar-29
SW-Version: Not applicable

MD: Alternating-pressure bed mattress overlay system

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

Vk_20210413_15

12.04.2021 

(Updated 29.04.2021)

F.M S.p.A.

DKS LOVERSAN
Model: see FSN
Lot: see FSN

MD: Infusion Sets and Accessories

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

Vk_20210406_02

28.04.2021

Arthrex INC

Angel cPRP Processing Set (EU)
Model: see FSN
Lot: All

MD: Blood centrifugation system containment kit

DE-1
FR-1
IT-1

Vk_20210426_22

27.04.2021

Xstrahl Limited

Xstrahl
Model: X80, X100, X150, X200, X300; As model numbers
SW-Version: 2.0.25.6 and above from date of release 2018-01-26

MD: Stationary orthovoltage therapeutic x-ray system

DE-1
EN-1

Vk_20210427_01

27.04.2021

Philips Medical Systems

Xper Flex Cardio Physiomonitoring System
Model: Model FC2010 and FC2020
S/N: see FSN
SW-Version: 1.6.8 and 1.5.19

MD: General-purpose multi-parameter bedside monitor

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

Vk_20210421_11

27.04.2021

Teleflex Malaysia

Rusch TracFlex Plus Set Cuffed
Model: see FSN
Lot: see FSN

Rüsch TracFlex Plus Tracheostomy Tube with Subglottic Suction Set, Cuffed
Model: see FSN
Lot: see FSN

Rusch TracFlex Plus Phonation Set, Cuffed
Model: see FSN
Lot: see FSN

Ruschcare TracFlex Plus Phonation Set, Cuffed
Model: see FSN
Lot: see FSN

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

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

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

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

DE-1
FR-1
IT-1

Vk_20210421_01

27.04.2021

Balt Extrusion

SILK VISTA
Model: ALL
Lot: ALL

MD: Bare-metal intracranial vascular stent

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

Vk_20210414_27

20.04.2021 

(Updated 26.04.2021)

VitreQ B.V.

CryoTreq
Model: CT00.D01
Lot: 20201169, 20201679, 20201776, 20202426, 20213725, 20214150, 20214155

MD: Ophthalmic cryosurgical system, mechanical

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

Vk_20210420_01

20.04.2021 

(Updated 26.04.2021)

Siemens Healthcare GmbH

Artis Zee
Model: see FSN

Axiom Artis
Model: see FSN

Artis Q
Model: see FSN

Artis Q zen
Model: see FSN

MD: Stationary angiographic x-ray system, digital

MD: Fluoroscopic x-ray system, angiography

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

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

Vk_20210414_15

22.04.2021 

(Updated 26.04.2021)

BIOPSYBELL S.R.L.

BIOPSYBELL products: DISKOM PERCUTANEOUS DISCECTOMY DEVICE, RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP, VERTEBROPLASTIC, AGO ESter, ESTER, BONE ACCESS NEEDLE, SCREW FIX
Model: see FSN

MD: Products for orthopaedic spine treatment

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

Vk_20210409_20

23.04.2021

Dräger Medical AG & Co.

Evita V600

Evita V800
S/N: All
SW-Version: SW1.05.00 and lower

Babylog VN800

Babylog VN600

MD: Neonatal/adult intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

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

Vk_20210416_18

23.04.2021

Medtronic Inc.

Azure, Astra Implantable Pulse Generators (IPGs) and Percepta, Serena, Solara Cardiac Resynchsronization therpy devices (CRT-Ps)
Model: W2DR01; W3DR01; W2SR01; W3SR01; X2DR01; X2SR01; W1TR04, W4TR04; W1TR05, W4TR05; W1TR06, W4TR06
S/N: all

AIMD: IPGs and CRT-P devices

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

Vk_20210407_17

23.04.2021

Medtronic Inc.

CareLink SmartSync Device Manager
Model: 24970A
Lot: n/a
S/N: n/a
SW-Version: All software before version 4.0

AIMD: Cardiac pulse generator programmer

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

Vk_20210407_16

13.04.2021 

(Updated 23.04.2021)

RaySearch Laboratories AB (publ)

RayCare
Model: RayCare 4A
S/N: build number: 4.0.0.60621
SW-Version: 4.0.0.60621

MD: Radiology information system application software

FR-1
EN-1

Vk_20210406_33

02.12.2020 

(Updated 23.04.2021)

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

Silica Substrate APTT Silica
Model: OQLS955502AD
Lot: see FSN

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

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

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

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

Vk_20201123_05

22.04.2021

ECO PHYSICS AG

Exhalyzer D
Model: M3024 with option M3024-12 (N2-MBW)
SW-Version: Spiroware 3.3.0 and older

MD: Pulmonary function analysis system, adult

EN-1

Vk_20210331_22

13.04.2021 

(Updated 21.04.2021)

Wilson-Cook Medical Inc.

Hemospray Endoscopic Hemostat
Model: HEMO-10-EU, HEMO-7-EU

MD: Inorganic haemostatic agent, sterile

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

Vk_20210407_05

13.04.2021 

(Updated 21.04.2021)

Fresenius Kabi AG

Exelia SP
Model: Z084010

MD: Syringe pump

FR-1
EN-1

Vk_20210407_04

21.04.2021

Ulrich Medical GmbH & Co.KG

Disposable cuff
Model: All codes Starting with UT 133XX

MD: Tourniquet cuff, single-use

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

Vk_20210406_31

17.10.2018 

(Updated 21.04.2021)

Medtronic Inc.

CareLink Programmer
Model: 2090
S/N: All

CareLink Encore Programmer
Model: 29901
S/N: All

AIMD: Cardiac pulse generator programmer

AIMD: Cardiac pulse generator programmer

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

Vk_20181015_09

20.04.2021

Richard Wolf GmbH

LASER FIBER DISPOSABLE and REUSABLE
Model: 87501200, 87501272, 87501550, 87501800, 875011000, 875013650, 87502200, 487501200, 487501272, 487501550, 487501800, 4875011000, 4875013650, 487502200
Lot: All lots with production date since 01.01.2016

MD: Laser lithotripsy system

DE-1
FR-1
IT-1

Vk_20210413_10

20.04.2021

B. Braun Melsungen AG

customer specific set including BD Venflon Pro Safety I.V. Cannula
Model: see FSN
Lot: see FSN

MD: customer specific set

DE-1
FR-1

Vk_20210409_15

24.03.2021 

(Updated 20.04.2021)

Welch Allyn Inc

AM12M Acquisition Module
Model: 9293-065-50
Lot: see FSN

MD: Electrocardiograph, professional, multichannel

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

Vk_20210323_11

19.04.2021

Boston Scientific Corporation

Upsylon Y Mesh Kit with Colpassist
Model: See FSN
Lot: See FSN
S/N: See FSN

MD: Pelvic organ prolapse surgical mesh, synthetic polymer

DE-1
FR-1
EN-1

Vk_20210413_01

17.03.2021 

(Updated 19.04.2021)

Given Imaging Inc

Bravo pH Capsule Delivery Dev and Bravo CF Capsule Delivery
Model: FGS-0312, FGS-0313, FGS-0635, FGS-0636

MD: Gastrointestinal telemetric monitoring system

DE-1
DE-2a
DE-2b
FR-1
FR-2a
FR-2b
IT-1
IT-2a
IT-2b
EN-1
EN-2a
EN-2b

Vk_20210308_16

27.03.2017 

(Updated 19.04.2021)

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

Vk_20170320_02

16.04.2021

Vapotherm, Inc.

Vapotherm Oxygen Assist Module (OAM)
Model: PF-OAM-MAS; PF-OAM-NEL; PF-OAM-MAS; PF-OAM-NEL
Lot: Any units upgraded to Software Version 2.5.0 which began on 29-Jan-2021
S/N: Any units upgraded to Software Version 2.5.0 which began on 29-Jan-2021
SW-Version: 2.5.0

MD: Oxygen Assist Module

DE-1

Vk_20210324_04

27.05.2020 

(Updated 16.04.2021)

Elekta Ltd

Elekta Unity

MD: Linear accelerator system

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

Vk_20200525_05

07.04.2021 

(Updated 15.04.2021)

Hitachi Ltd.

Hitachi ALOKA ARIETTA, Hitachi ARIETTA
Model: ALOKA ARIETTA 850, ALOKA ARIETTA 850SE; ARIETTA 750SE, ARIETTA 750LE, ARIETTA 750VE
SW-Version: AR 850 Ver.4.0.0/4.0.1/4.0.2, AR 750 Ver.2.0.0

MD: General-purpose ultrasound imaging system

DE-1 (ALOKA AR850)
DE-1 (AR750)
EN-1 (ALOKA AR850)
EN-1 (AR750)

Vk_20210401_01

15.04.2021

RanD S.r.l

Disposable devices and accessories for Hyperthermic Perfusion treatments for use with PERFOMER HT and PERFORMER LRT equipment
Model: see FSN
Lot: see FSN

MD: Intravascular/intracavitary-circulation hyperthermia system set

DE-1
FR-1
EN-1

Vk_20210318_05

14.04.2021

NeuMoDx Molecular, a QIAGEN Company

NeuMoDx Saliva Collection Kit
Model: 100500
Lot: 108236
S/N: N/A
SW-Version: n/a

IVD: Saliva specimen collection kit IVD

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

Vk_20210414_25

14.04.2021

C + TBA Cells + Tissuebank Austria

Allografts C + TBA
Model: ASP310
Lot: 310X21013S

: Allograft (devitalisiert)

DE-1
EN-1

Vk_20210408_16

14.04.2021

Synedra Information Technologies GmbH

synedra View
SW-Version: 19.x (Zephyr), 20.x (Kassiopeia)

MD: Radiology picture archiving and communication system

DE-1
FR-1
EN-1

Vk_20210408_15

14.04.2021

PREVOR

DIPHOTERINE
Model: DAPD
Lot: See FSN
S/N: N/A

HEXAFLUORINE
Model: DAPF
Lot: See FSN
S/N: N/A

MD: Solution, irrigating, non-injectable

MD: Solution, irrigating, non-injectable

DE-1
FR-1
IT-1

Vk_20210407_03

13.04.2021

VENITI, Inc.

VICI Venous Stent System
Model: See FSN
Lot: See FSN
S/N: Not Applicable
SW-Version: N/A

VICI RDS Venous Stent System
Model: See FSN
Lot: See FSN
S/N: Not Applicable

MD: Iliofemoral vein stent

MD: Iliofemoral vein stent

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

Vk_20210413_02

13.04.2021

Clinical Laserthermia Systems AB

TRANBERG
Model: see FSN
Lot: see FSN

MD: Temperature probes; Laser applicators, non cooled

DE-1
EN-1

Vk_20210409_06

13.04.2021

Randox Laboratories Ltd

Calibration Serum Level 3
Model: CAL2351
Lot: 1162UE

IVD: Multiple-type clinical chemistry analyte profile IVD, calibrator

FR-1
EN-1

Vk_20210408_24

12.04.2021

Insulet Corporation

Omnipod DASH Insulin Management System
Model: PT-000002-XX-XXX
Lot: N/A
SW-Version: N/A

MD: Ambulatory insulin infusion pump/blood glucose analyser system

IT-1.1
IT-1.2

Vk_20210224_20

12.04.2021

Philips Goldway (Shenzhen) Industrial Inc.

Efficia DFM 100
Model: 866199
S/N: see FSN

MD: Rechargeable professional automated external defibrillator

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

Vk_20210222_16

08.04.2021

Aptissen SA

Healaflow
Model: A-HEA060
Lot: 341335/1

MD: Eye drain

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

Vk_20210401_18

30.03.2021 

(Updated 08.04.2021)

Oy Reagena Ltd

ReaScan TBE lgM
Model: 114106
Lot: XA13/1

ReaScan CXCL 13
Model: 114253
Lot: XD22/1

IVD: Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic test (ICT), rapid

IVD: C-X-C motif chemokine ligand 13 (CXCL13) IVD, kit, immunochromatographic test (ICT), rapid

FR-1 - CXCL13
FR-1 - TBE-IgM
EN-1 - CXCL13
EN-1 - TBE-IgM

Vk_20210326_17

06.04.2021

SERF

Jauges broche F.A.S.T.
Model: 3663165003513, 3663165003520, 3663165003704
Lot: all

MD: Orthopaedic prosthesis implantation instrument, reusable

FR-1

Vk_20210331_03

06.04.2021

Medtronic Inc.

Intellis Recharger
Model: 97755
S/N: all

AIMD: Noninvasive device battery charger

DE-1
FR-1
IT-1

Vk_20210325_12

06.04.2021

Covidien LLC

Surgiwand II Auto Suture Suction and Irrigation Device
Model: 178083, 178093, 178094
Lot: See FSN

MD: Surgical irrigation/aspiration cannula, non-illuminating, single-use

DE-1

Vk_20210322_07

06.04.2021

EUROIMMUN Medizinische Labordiagnostika AG

EUROLINE sample buffer
Lot: D200114AB

IVD: Sample buffer

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

Vk_20210309_16

02.12.2020 

(Updated 06.04.2021)

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

Vk_20201130_17

01.04.2021

Medline International France SAS

Medline Sterile Procedure Trays
Model: 1417234-3, DGFEY067C, DGFEY101, DGFEY101A, FGREY005C, HGGEN034B, HGGEY041C, HGGEY046A, HGGEY073A, HGGEY094, HGGEY094A, PGSEY071A, QDYN1569-1, ZGZEN017A, ZGZEN028A, ZGZEN028B, ZGZEN045B, ZGZEY002I, ZGZEY020G, ZGZEY036

MD: Syringe

DE-1
FR-1
EN-1

Vk_20210326_10