Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2020 – 31.08.2020

08.01.2020 

(Updated 01.09.2020)

Abbott - Thoratec Corporation

Heartmate III
Model: 106525, 106525INT / 106524, 106524INT LVAS HM3 KIT
Lot: All Batch Numbers of the model 106525, 106525INT
S/N: All Serial Numbers of the model 106524, 106524INT LVAS HM3 KIT

AIMD: Implantable ventricular circulatory assist system

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

Vk_20191202_22

26.08.2020 

(Updated 31.08.2020)

Olympus Medical Systems Corp.

EVIS EXERA II BRONCHOVIDEOSCOPE
Model: BF-Q180; N2117430, N2117460, N3630730, N3630760, N3820730, N3820760
S/N: All

MD: Flexible video bronchoscope, reusable

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

Vk_20200824_15

26.08.2020 

(Updated 31.08.2020)

VBM Medizintechnik GmbH

Laryngeal Tube
Model: See Annex 1
Lot: See Annex 1

MD: Laryngeal mask airway, reusable

DE-1
EN-1

Vk_20200820_17

31.08.2020

MAQUET Cardiopulmonary GmbH

HCU40
Model: 70104.4054; 70105.4917;70104.4054; 70105.4917
Lot: N/A
S/N: All Serial Numbers below 90442012
SW-Version: N/A

MD: Cardiopulmonary bypass system heat exchanger, reusable

DE-1
FR-1
EN-1

Vk_20200812_12

19.08.2020 

(Updated 28.08.2020)

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
FR-1
IT-1
EN-1

Vk_20200817_27

28.08.2020

Roche Diabetes Care GmbH

Accu Chek Guide test strips
Model: 07453744016, 08721106001
Lot: 101130 (Mfr date 2019-04-14, Exp date 2020-10-11), 101261 (Mfr date 2019-04-29, Exp date 2020-10-26)

IVD: Glucose IVD, reagent

DE-1
FR-1
IT-1

Vk_20200812_01

28.08.2020

MicroPort Orthopedics Inc.

PROFEMUR Ti Long/X-long Modular Necks
Model: see FSN
Lot: see FSN

MD: Femoral head/stem prosthesis adaptor

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

Vk_20200731_08

28.08.2020

MicroPort Orthopedics Inc.

PROFEMUR Ti and CoCr Modular Necks
Model: see FSN
Lot: see FSN

MD: Femoral head/stem prosthesis adaptor

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

Vk_20200731_07

27.08.2020

Carl Zeiss Meditec AG

VISUREF 150 Autorefractor
Model: 000000-2227-967

VISULENS 550 Digital Lensmeter
Model: 000000-2268-038

MD: Ophthalmic refractometer, automated

MD: Automated lensmeter

DE-1

Vk_20200813_07

26.08.2020

Intersurgical Ltd

AbCan Spherasorb
Model: 2199001
Lot: 1190929, 1190930, 1200719, 1201724, 1201864, 1202798

AbCan LoFlosorb
Model: 2199003
Lot: 1191191

MD: Carbon dioxide absorber, single-use

MD: Carbon dioxide absorber, single-use

EN-1

Vk_20200820_27

26.08.2020

IMACTIS SAS

CT-Navigation system
Model: MA-J02000 or MA-J00180

MD: Robotic surgical navigation system

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

Vk_20200819_15

25.08.2020

Medline Industries Inc.

Sterile Gauze
Model: GS10P757512XR, GS10P102012XR
Lot: QDPAN0327192, QDPAN0204201, OGPAN0327192, OGPAN051419G, OGPAN0710191, OGPAN090319A, OGPAN1017193

MD: Swab

DE-1
EN-1

Vk_20200824_13

25.08.2020

ArthroCare Corporation

SpeedStitch Needle
Model: OM-8850
Lot: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2032526, 2033815, 2036941, 2037604, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575 & 2051239

MD: Suturing needle, single-use

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

Vk_20200821_24

25.08.2020

Apollo Endosurgery Inc

LAP-BAND System and Accessories
Model: C-20360, C-20365, C-20304, C-20306

MD: Gastric band

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

Vk_20200821_06

25.08.2020

Covidien LLC

Endo Gia Auto Suture Universal Articulating Loading Unit
Model: 030450, 030451, 030452, 030453, 030454, 030455, 030457, 030458
Lot: See appendix of FSN

MD: Surgical staple loading unit, non-cutting

DE-1
FR-1
IT-1

Vk_20200821_05

11.08.2020 

(Updated 25.08.2020)

Randox Laboratories Ltd

Randox Soluble Transferrin Receptors Cal & Control
Model: TF10161; TF10162
Lot: siehe FSN

IVD: Soluble transferrin receptor IVD, calibrator

DE-1
DE-2

Vk_20200729_04

15.06.2020 

(Updated 21.08.2020)

Handicare AB

SwiftHook
Model: 70200008
S/N: All

MD: Patient Lift Hook

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

Vk_20200511_12

20.08.2020

Elekta Ltd

Elekta Unity

MD: Linear accelerator system

DE-1
FR-1
IT-1

Vk_20200813_09

19.08.2020 

(Updated 20.08.2020)

B. Braun Melsungen AG

GASTRO DUODENAL FEEDING TUBES WITH GUIDE
Model: see Section 8;see Section 8
Lot: all

MD: Nasogastric feeding tube

DE-1
FR-1
IT-1

Vk_20200813_04

06.08.2020 

(Updated 20.08.2020)

Globus Medical

ALTERA
Model: see FSN
Lot: see FSN

MD: Metallic spinal interbody fusion cage

EN-1
EN-2

Vk_20200730_05

19.08.2020

Siemens Healthcare Diagnostics Inc

Atellica UAS 800 analyzer
Model: SMN 11065004
SW-Version: All versions up to and including V4.0.220

IVD: Urine analyser IVD, laboratory, automated

FR-1
EN-1

Vk_20200813_10

14.08.2020 

(Updated 19.08.2020)

Barnaux Healthcare B.V.

Hydraclair ampoules
Model: 042001
Lot: Y351C
S/N: QEY08007 EYEYE HYDRACLAIR AMPUL WEST

MD: Eye lubricant

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

Vk_20200804_23

18.08.2020

Medineering GmbH

Surgical Base System
Model: SBS 1.3.2 and SBS 1.4
S/N: see FSN

MD: Positioning Aids

DE-1
EN-1

Vk_20200812_10

18.08.2020

ITH icoserve technology for healthcare GmbH

syngo.share view diagnostic
Model: 11250008
SW-Version: VA24 - VA28

MD: Radiology PACS software

DE-1

Vk_20200811_25

18.08.2020

Riverpoint Medical

Velosorb Fast Surgical Suture
Lot: see FSN
S/N: see FSN

MD: Surgical Suture

DE-1
FR-1
IT-1

Vk_20200810_02

18.08.2020

Smith & Nephew Orthopaedics AG

POLARSTEM COLLAR Reamer Guide
Model: 75102205
Lot: A56281, A57539, A58660, A60630, A61590, A62616 and A62689

MD: Orthopaedic reamer guide

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

Vk_20200731_24

07.08.2020 

(Updated 17.08.2020)

Datascope Corp.

IAB intra aortic balloon
Model: see FSN
Lot: see FSN
S/N: see FSN

MD: Intra-aortic balloon catheter

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

Vk_20200806_17

06.08.2020 

(Updated 17.08.2020)

Maquet Critical Care AB

SoKINOX / SERViNO
Model: SoKINOX NO Delivery and Monitoring System, SERVINO NO Delivery and Monitoring System;66 94 550 , 68 81 700
S/N: See Consignee list , EVU-207352

MD: Nitric oxide delivery unit, system-based

DE-1
EN-1

Vk_20200721_14

14.08.2020

Natus Medical Incorporated

Embletta Gold USB Cable
Model: 2020303;2020303

MD: USB Cable

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

Vk_20200806_18

12.08.2020 

(Updated 14.08.2020)

DiaSorin S.p.A.

LIAISON Measles IgM
Model: 318820
Lot: 174026

IVD: Measles virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

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

Vk_20200804_24

31.07.2020 

(Updated 14.08.2020)

Rocket Medical PLC

Rocket FBS Kit for Lactate with Sampling Wand
Model: R57028-00-SW
Lot: 000000000483581 and 000000000486235

MD: Foetal blood sampling kit, scalp

DE-1
FR-1
EN-1

Vk_20200723_23

13.08.2020

NuVasive, Inc.

PRECICE Bone Transport Nail
Model: BT10-60SJ280-6
Lot: Submitted in the initial report under section 8.
S/N: N/A
SW-Version: N/A

MD: Long bone distraction rod, magnetic

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

Vk_20200729_07

23.01.2020 

(Updated 13.08.2020)

Stryker Medical

Lifepak 15
Model: V15-2-XXXXXX
S/N: See FSN

MD: Physiologic-monitoring defibrillation system

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

Vk_20200113_03

12.08.2020

Siemens Healthcare GmbH

Cios Alpha & Cios Spin
Model: see FSN
S/N: see FSN

MD: Basic diagnostic x-ray system

DE-1
FR-1
EN-1

Vk_20200804_26

12.08.2020

Randox Laboratories Ltd

RANDOX AMMONIA
Model: AM1015, AM1054
Lot: 517541, 512103

IVD: Ammonia IVD, kit, enzyme spectrophotometry

DE-1
EN-1

Vk_20200804_09

06.08.2020 

(Updated 12.08.2020)

Weinmann Emergency Medical Technology GmbH + Co. KG

MEDUMAT Standard
Model: 28710
S/N: alle Geräte-Seriennummern seit Produkteinführung
SW-Version: kleiner gleich 4.13

MD: Transport electric ventilator

DE-1
FR-1
IT-1

Vk_20200729_14

11.08.2020

Boston Scientific Corporation

IMAGER II Angiographic Catheter
Model: See FSN
Lot: All

MD: Angiographic catheter, single-use

DE-1
FR-1
EN-1

Vk_20200810_15

11.08.2020

Prodimed

One Shot product range
Model: see fsn

MD: surgical instruments and sets

EN-1

Vk_20200806_06

11.08.2020

Karl Storz SE & Co.KG

Tubing Set, Irrigation, PC
Model: 437000;031523-10
Lot: 190930, 191008

MD: Surgical irrigation tubing set, single-use

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

Vk_20200805_08

11.08.2020

AuXin Surgery s.a.

CADISS Kit
Model: CADISS REMOTE Kit; AU-0-001
Lot: AU0001200116

MD: Dissection kit

DE-1
FR-1
IT-1

Vk_20200804_01

11.08.2020

Cardinal Health

Protexis Latex Micro Surgical Gloves
Model: 2D72NT55X, 2D72NT60X, 2D72NT65X, 2D72NT70X, 2D72NT75X, 2D72NT80X, 2D72NT85X, 2D72NT90X
Lot: see FSN
SW-Version: N/A

MD: Hevea-latex surgical glove, non-powdered

DE-1
FR-1
IT-1

Vk_20200729_05

11.08.2020

Hell & Co GmbH

Kundenspezifische Sets & Behandlungseinheiten
Model: 170000173, 170000188, 170000205, 170000219, 170000225, 170000247, 170000300, 170000314, 170000326
Lot: see FSN

MD: Casework, Multipurpose

DE-1
FR-1
EN-1

Vk_20200724_14

20.03.2020 

(Updated 11.08.2020)

Welch Allyn Inc

Cable Leads
Model: see FSN

S4, T12, X12+
Model: see FSN

ELI devices, RScribe, ELI PC, AM12, AM15, WAM
Model: see FSN

H12+
Model: see FSN

S12/S19
Model: see FSN

Q-Stress
Model: see FSN

Xscribe
Model: see FSN

MD: Electrocardiographic lead set, reusable

MD: Electrocardiography telemetric monitoring system transmitter

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiographic ambulatory recorder

MD: Multiple-patient intensive/general healthcare physiologic monitoring system

MD: Cardiopulmonary stress exercise monitoring system computer

MD: Cardiac stress exercise monitoring system

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

Vk_20200316_04

21.07.2020 

(Updated 10.08.2020)

Siemens Healthcare GmbH

Cios Alpha & Cios Spin
S/N: see FSN

MD: Basic diagnostic x-ray system

DE-1
FR-1
EN-1

Vk_20200720_09

07.08.2020

Philips Medical Systems

HeartStart MRx Defibrillator/ Monitor
Model: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9;NA
S/N: see FSN version "USER"

MD: Rechargeable professional automated external defibrillator

DE-1-DISTRIBUTOR
DE-1-USER
FR-1-USER
IT-1-USER
EN-1-DISTRIBUTOR
EN-1-USER

Vk_20200806_14

05.08.2020 

(Updated 07.08.2020)

Roche Diagnostics GmbH

Elecsys Anti-TPO
Model: 06368590190

IVD: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
EN-1

Vk_20200731_20

04.08.2020 

(Updated 07.08.2020)

Olympus Surgical Technologies America

Gyrus ACMI Smart Prostheses
Model: Smart Piston 0,4mm x 5,25mm; art. nr. on packaging: 70142168; ordering art. nr.: EG70142168
Lot: LOT PR898678

MD: Polyethylene craniofacial tissue reconstructive material

DE-1
EN-1

Vk_20200729_16

28.07.2020 

(Updated 07.08.2020)

Mint Medical GmbH

Mint Lesion
SW-Version: 3.5.0, 3.5.1, 3.5.2, 3.6.0, 3.7.0, 3.7.1 in combination with one of the following reading templates: LI-RADS v2018, Colorectal cancer (TNM 8.0/ESGAR) or Esophageal/Gastric cancer (TNM 8.0)

MD: Radiology DICOM image processing application software

DE-1
FR-1
EN-1

Vk_20200723_14

29.07.2020 

(Updated 06.08.2020)

VISUS Health IT GmbH

JiveX
SW-Version: 5.2, 5.2.0.1, 5.2.0.2, 5.2.0.3, 5.2.0.4, 5.2.0.5, 5.2.0.6

MD: Picture archiving and communication system

DE-1
EN-1

Vk_20200721_09

05.08.2020

Sorin Group Italia Srl

Dual collapser
Model: ICV1345, ICV1346, ICV1349, ICV1350
Lot: 2002060216; 2002060218, 2002060219; 2002060220; 2001300339; 2002130159; 2002200196; 2001300341; 2002060224; 2002130160; 2002130161; 2002130162; 2002200198; 2002200199
SW-Version: Not Applicable

MD: Self-expandable heart valve bioprosthesis collapsing tool, single-use

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

Vk_20200727_05

04.08.2020

Qiagen GmbH

QIAstat-Dx Respiratory SARS-CoV-2 Panel
Model: 691214
Lot: 166022253; 166022463; 166024434; 166029247
S/N: n/a
SW-Version: n/a

IVD: Other Nucleic Acid Identification - automated

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

Vk_20200728_24

31.07.2020 

(Updated 03.08.2020)

Inzek International Trading B.V.

COVID-19 IgG/IgM Rapid Test Cassette
Model: BNCP-402, BNCP-402E
Lot: BNCP40200074, BNCP40200077, BNCP40200078, BNCP40200080, BNCP40200083, BNCP40200084, BNCP40200087, BNCP40200088, BNCP40200093, BNCP40200097, BNCP40200098, BNCP40200099, BNCPE40200085, BNCPE40200086

IVD: Coronavirus

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

Vk_20200729_12

21.07.2020 

(Updated 03.08.2020)

Smith & Nephew, Inc.

GENESIS II Tibial Base Plate
Model: 71420164, 71420166, 71420184
Lot: see FSN, Appendix 1

MD: Uncoated knee tibia prosthesis, metallic

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

Vk_20200717_07

21.07.2020 

(Updated 03.08.2020)

Medtronic MiniMed

Guardian Connect Application
Model: CSS7200
SW-Version: Software version v3.2.4

MD: Patient health record information system application software

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

Vk_20200716_04

27.05.2020 

(Updated 03.08.2020)

Elekta Global Post Market Surveillance

Elekta Unity

MD: Linear accelerator system

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

Vk_20200525_05

31.07.2020

MedCom Gesellschaft fuer medizinische Bildverarbeitung mbH

Mobile US
Model: 2.1
S/N: 5052-20C-0060
SW-Version: 3.1.0.4

MD: Data Processors, Ultrasonic Scanning

EN-1

Vk_20200731_06

21.07.2020 

(Updated 31.07.2020)

Ortho Clinical Diagnostics Inc.

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

VITROS TBIL Slides
Model: 8159931
Lot: all lots

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

IVD: Multiple clinical chemistry analyte IVD, reagent

IVD: Total bilirubin IVD, reagent

IVD: Multiple clinical chemistry analyte IVD, reagent

DE-1
EN-1

Vk_20200717_22

07.04.2020 

(Updated 31.07.2020)

LeMaitre Vascular, Inc.

LeMaitre Over-the-Wire Embolectomy Catheters
Model: 1651-84, 1651-88
Lot: See FSN
S/N: N/A
SW-Version: N/A

MD: Thrombectomy balloon catheter

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

Vk_20200325_04

19.07.2019 

(Updated 31.07.2020)

Qiagen GmbH

QIAsymphony SP
Model: 9001297
SW-Version: 5.0.3

IVD: SP Hardware + accessories + consumables + software

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

Vk_20190709_12

25.03.2020 

(Updated 30.07.2020)

Inpeco S.A.

FlexLab
Model: see FSN
SW-Version: see FSN

IVD: Specimen processing instrument IVD, automated

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

Vk_20200324_01

28.07.2020

STERIS Surgical Technologies SAS

CMAX3 and CMAX 3-DRIVE
S/N: 95584; 98579; 98585; 101674; 102219; 102220; 120821; 120822

MD: Universal operating table, electromechanical

FR-1
EN-1
EN-2

Vk_20200716_02

22.07.2020 

(Updated 28.07.2020)

Medtronic Inc.

SynchroMed II Clinician Programmer Application
Model: A810
Lot: n/a
S/N: All
SW-Version: 1.1.300

AIMD: Infusion pump programmer

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

Vk_20200715_03

21.07.2020 

(Updated 28.07.2020)

Medtronic Inc.

SynchroMed II Clinician Programmer Application
Model: A810
Lot: n/a
S/N: All
SW-Version: 1.0.7493 and 1.1.300

AIMD: Infusion pump programmer

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

Vk_20200715_02

13.04.2020 

(Updated 28.07.2020)

Inpeco S.A.

Aptio Automation
Model: see FSN
SW-Version: see FSN

IVD: Specimen processing instrument IVD, automated

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

Vk_20200324_03

25.03.2020 

(Updated 28.07.2020)

Inpeco S.A.

ACCELERATOR a3600
Model: see FSN
SW-Version: see FSN

IVD: Specimen processing instrument IVD, automated

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

Vk_20200324_02

16.05.2018 

(Updated 28.07.2020)

HeartWare Inc.

HeartWare Ventricular Assist System
Model: Controller - 1400, 1401, 1403, 1407, 1420 ; DC Adapter - 1435, 1440 ; AC Adapter - 1425, 1430 ; Battery Pack - 1650
S/N: All

AIMD: Implantable ventricular circulatory assist system

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

Vk_20180509_01

24.07.2020

Heidelberg Engineering GmbH

ANTERION
SW-Version: PC-Softwareversionen 1.2.1 und 1.3

MD: Eye anterior segment analyser

DE-1
FR-1
IT-1

Vk_20200724_01

13.07.2020 

(Updated 24.07.2020)

Becton Dickinson Diagnostic Systems

BD MAX SARS-CoV-2 Reagents
Model: 445003; 445003-01
Lot: all

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

DE-1
FR-1
EN-1

Vk_20200710_12

23.07.2020

Völker GmbH

S 966

MD: Beds, Electric

DE-1
FR-1

Vk_20200716_14

16.07.2020 

(Updated 23.07.2020)

Olympus Medical Systems Corp.

Single use guide sheath kit
Model: K-401 & K-402; N6000630 & N6000730
Lot: all

MD: Flexible endoscopic biopsy forceps, single-use

DE-1
EN-1

Vk_20200710_08

22.07.2020

SICAT GmbH & Co. KG

SICAT Implant V2.0
Model: SICAT Implant V2.0
Lot: V2.0
SW-Version: V2.0

MD: Radiology PACS software

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

Vk_20200716_01

20.07.2020 

(Updated 21.07.2020)

Weinmann Emergency Medical Technology GmbH + Co. KG

Einweg-Patientenschlauchsystem ohne BiCheck Flows
Model: see FSN

MD: Anaesthesia breathing circuit, single-use

DE-1
EN-1

Vk_20200720_06

21.07.2020

Coris BioConcept

HAT Sero K-SeT
Model: K-15S2
Lot: 42874D2003

IVD: In vitro rapid detection test of antibodies specific to Trypanosoma brucei gambiense in human whole blood, serum or plasma

EN-1

Vk_20200715_16

12.02.2020 

(Updated 17.07.2020)

Siemens Healthcare Diagnostics Inc

CLINITEK Status+
Model: see FSN
SW-Version: V 2.620

CLINITEK Status Connect System

CLINITEK Status Connect Platform
Model: see FSN
SW-Version: V.2.4.2.0

IVD: Manual urine analyser

IVD: Manual urine analyser

IVD: Urine analyser IVD, point-of-care

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

Vk_20200210_11

16.07.2020

DeVilbiss Healtcare LLC

DeVilbis Compact 5
Model: 525K5

MD: Oxygen Concentrators

DE-1
EN-1

Vk_20200603_32

22.04.2020 

(Updated 16.07.2020)

Roche Diagnostics GmbH

cobas 6500 urine analyzer series
SW-Version: 2.2.0 - 2.2.8

cobas u 601 urine analyzer
Model: 06390498001
SW-Version: 2.2.0 - 2.2.8

cobas u 701
Model: 06390501001
SW-Version: 2.2.0 - 2.2.8

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

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

Vk_20200416_02

15.07.2020

AIR LIQUIDE MEDICAL SYSTEMS

MONNAL T50
Model: MONNAL T50 / MONNAL T50DE / MONNAL T50JP / MONNAL T50CHINA; KA027500 / KC037600 / KC039100 / KC027220
SW-Version: PSU-0111 or lower

MD: Neonatal/adult intensive-care ventilator

DE-1
FR-1
EN-1

Vk_20200715_19

15.07.2020 

(Updated 15.07.2020)

Teleflex Medical

RUSCH GREENLITE Mac Laryngoscopes
Model: Green Rusch Lite Miller 2, Green Rusch Lite Miller 3, Green Rusch Lite Miller 4, Green Rusch Lite Mac 2, Green Rusch Lite Mac 3, Green Rusch Lite Mac 4, Green Rusch Lite Mac 3.5, 004550002, 004550003, 004550004, 004551002, 004551003, 004551004, 004551035
Lot: see FSN

MD: Laryngoscope blade, single-use

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

Vk_20200709_18

14.07.2020

Wiros GmbH & 3M Health Care

Hygienemasken
Model: 2582.2862; 2545.4257
Lot: Lot (09-12/2007-) WH 365/1-13); Lot (09-12/2007-) WH 365/1-13

Hygienemasken
Model: 5124.1010
Lot: all

MD: Surgical Masks

MD: Surgical Masks

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

Vk_20200710_06

14.07.2020

B. Braun Melsungen AG

Ringer Spüllösung Ecobag 3000ml
Model: FREU924
Lot: 201127671

Ringer Spüllösung Ecobag 5000ml
Model: FREU964
Lot: 201917671N

NaCI 0.9% Spüllösung Ecobag 5000 ml
Model: FREU950
Lot: 201127672; 201137671; 201237671; 201767671N

NaCI 0.9% Spüllösung Ecobag 3000 ml
Model: FREU910
Lot: 201067672; 201077671; 201077672; 201117671; 201117672; 201627671N; 201657671N; 201737671N; 201757671N; 201847671N; 201857671N

NaCI 0.9% Spüllösung Ecobag 2000 ml
Model: FREU850
Lot: 201217672

MD: Surgical/medical procedure irrigation fluid

MD: Surgical/medical procedure irrigation fluid

MD: Surgical/medical procedure irrigation fluid

MD: Surgical/medical procedure irrigation fluid

MD: Surgical/medical procedure irrigation fluid

DE-1
FR-1
IT-1

Vk_20200708_24

14.07.2020

GE Medical Systems Information Technologies, Inc.

Carescape One
Model: see FSN
S/N: see FSN
SW-Version: see FSN

MD: Patient monitoring system module, multifunction

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

Vk_20200708_22

14.07.2020

Smith & Nephew, Inc.

SUTUREFIX ULTRA 1.7MM DRILL (S)
Model: 72203855
Lot: 2038366, 2039311 and 2046505

MD: Fluted surgical drill bit, reusable

DE-1
FR-1
IT-1

Vk_20200703_09

30.06.2020 

(Updated 13.07.2020)

Biosense Webster, Ltd

Carto 3 System
Model: see fsn
S/N: all

CARTO VISITAG
Model: see fsn
S/N: all

MD: Cardiac mapping system

MD: Cardiac mapping system application software

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

Vk_20200624_16

09.07.2020

Karl Storz GmbH & Co. KG

Rubber Bulb, latex-free
Model: 437000;437000
Lot: all

MD: Atomizer

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

Vk_20200708_17

25.06.2020 

(Updated 09.07.2020)

Medtronic Xomed

Integrated Power Consoles (IPCs) in combination with StraightShot M5 Microdebrider handpiece
Model: Console:1898001, EC300, 2340000, Handpiece: 1899200
S/N: Console: Serial numbers with software version v2.7.3.0 installed , Handpiece: all
SW-Version: v2.7.3.0 (CFN 1898072)

MD: Multi-purpose surgical power tool system, line-powered

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

Vk_20200616_12

08.07.2020 

(Updated 09.07.2020)

Eurocor Tech GmbH

Freeway 014
Model: All

Freeway 035
Model: All

MD: Catheters, Vascular, Angioplasty, Balloon

MD: Catheters, Vascular, Angioplasty, Balloon

DE-1
FR-1
EN-1

Vk_20200616_05

08.07.2020

INTEGRA MICRO FRANCE SAS

Integra MicroFrance Bipolar Electrosurgical
Model: CEV130, CEV133, CEV134, CEV134BG, CEV136, MCL34, MCL340
Lot: see FSN

MD: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

EN-1

Vk_20200703_11

07.07.2020

Boston Scientific Corporation

Captivator
Lot: See FSN
S/N: See FSN

Captiflex
Lot: See FSN
S/N: See FSN

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

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

DE-1
FR-1
EN-1

Vk_20200707_02

07.07.2020

SENTINEL CH SpA

Fructosamine
Model: 3R05-31

IVD: Fructosamine IVD, kit, enzyme spectrophotometry

DE-1
EN-1

Vk_20200701_15

30.06.2020 

(Updated 07.07.2020)

Cardionovum GmbH

Legflow RX Paclitaxel releasing peripheral balloon dilatation catheter
Model: all

Legflow OTW Paclitaxel releasing peripheral balloon dilatation catheter
Model: all

MD: Peripheral angioplasty balloon catheter, drug-coated

MD: Peripheral angioplasty balloon catheter, drug-coated

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

Vk_20200616_02

11.11.2019 

(Updated 07.07.2020)

Roche Diagnostics GmbH

Elecsys Troponin-T hs STAT
Model: see FSN
Lot: see FSN

Elecsys Troponin T hs
Model: see FSN
Lot: see FSN

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

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

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

Vk_20191031_01

10.07.2019 

(Updated 07.07.2020)

Roche Diagnostics GmbH

Elecsys Anti-CCP
Model: 05031656190, 05031656160, 07251670190
Lot: (368033, 376804, 389152), (358545, 368037, 376808, 389165), (368029, 376648, 388800)

IVD: Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)

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

Vk_20190704_03

01.07.2020 

(Updated 03.07.2020)

Abbott

Alinity ci-series System Control Module
Model: 03R70-01
S/N: all
SW-Version: all

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1-A
DE-1-B
DE-1-C
FR-1-A
FR-1-B
IT-1-B
EN-1-A
EN-1-B
EN-1-C

Vk_20200623_