Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.05.2020 – 30.06.2020

Опубліковано 01.07.2020 о 14:51

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

16.06.2020 р.

(Updated 08.07.2020 р.)

Siemens Healthcare Diagnostics Inc

Chemistry Calibrator
Model: 10312279, 09784096; 11099411
Lot: 534177, 534177A, 534177B, 534177C, 534177D, 960742; 534179, 534179A, 534179B, 534179C, 534179D, 534179E, 911591, 911591A, 911591B, 911591C
S/N: N/A
SW-Version: N/A

IVD: Multiple clinical chemistry analyte IVD, calibrator

DE-2 (ADVIA Chemistry)
DE-2 (Atellica CH)
EN-1 (ADVIA Chemistry)
EN-1 (Atellica CH)
EN-2 (ADVIA Chemistry)
EN-2 (Atellica CH)
EN-3 (ADVIA Chemistry)
EN-3 (Atellica CH)
EN-4 (ADVIA Chemistry)
EN-4 (Atellica CH)

Vk_20200612_02

22.04.2020 р.

(Updated 08.07.2020 р.)

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
FR-1
EN-1
EN-2

Vk_20200416_02

16.05.2018 р.

(Updated 08.07.2020 р.)

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

Vk_20180509_01

07.07.2020 р.

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 р.

Smith & Nephew, Inc.

T-FIX RCG Sterile Drill
Model: 014771
Lot: 2042492

MD: Sterile Drill

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

Vk_20200703_10

07.07.2020 р.

SENTINEL CH SpA

Fructosamine
Model: 3R05-31

IVD: Fructosamine IVD, kit, enzyme spectrophotometry

EN-1

Vk_20200701_15

30.06.2020 р.

(Updated 07.07.2020 р.)

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 р.

(Updated 07.07.2020 р.)

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 р.

(Updated 07.07.2020 р.)

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 р.

(Updated 03.07.2020 р.)

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_11

30.06.2020 р.

Siemens Healthcare GmbH

syngo.via RT Image Suite, feature synthetic CT
Model: 10496180, 10561675
SW-Version: syngo.via VB30, syngo.via VB40

MD: CT system application software

DE-1
FR-1

Vk_20200625_09

30.06.2020 р.

Beckman Coulter Biomedical GmbH

DxA 5000
Model: DxA 5000;B87352
Lot: Not applicable
S/N: All
SW-Version: All

IVD: Specimen processing instrument IVD, automated

DE-1
EN-1

Vk_20200624_22

30.06.2020 р.

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur XP Rubella G (Rub G)
Model: 10310283
Lot: 16975222, 25881224 and 32323224

ADVIA Centaur XP Rubella M (Rub M)
Model: 10310285
Lot: 07257190 and 15401190

IVD: Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

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

DE-1
FR-1
EN-1

Vk_20200623_09

25.06.2020 р.

(Updated 30.06.2020 р.)

Incipio Devices

Offset Cup Impactor
Model: 183-151/00; 50341603; 01.15.10.0538; 50340409
Lot: 19J8932, 20J9956, 20J9057, 19J7479

MD: Orthopaedic implant impactor

EN-1
EN-2

Vk_20200619_24

28.04.2020 р.

(Updated 29.06.2020 р.)

Becton Dickinson and Company

PosiFlush XS
Model: 306572
Lot: 9182101, 9185822, 9192691, 9199773, 9204191, 9213726, 9224747, 9232938, 9235407, 9239399, 9248167, 9255893, 9263969

MD: Vascular catheter flush syringe

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

Vk_20200421_12

26.06.2020 р.

Dräger Medical AG & Co. KGaA

Perseus A500
Model: MK06000
S/N: multiple
SW-Version: SW2.0n

MD: Anaesthesia workstation, general-purpose

DE-1
FR-1
IT-1

Vk_20200626_01

26.06.2020 р.

Cimpax ApS

CIMPAX Conization Electrode
Model: 13x20mm;C31-18-121
Lot: 182402

MD: Open-surgery electrosurgical electrode, monopolar, single-use

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

Vk_20200625_01

16.04.2020 р.

(Updated 26.06.2020 р.)

The Binding Site Group Limited

Optilite Analyser
Model: IE700
SW-Version: 7.0 and 7.0.1

IVD: Single-channel clinical chemistry analyser IVD, laboratory, automated

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

Vk_20200414_02

28.11.2019 р.

(Updated 26.06.2020 р.)

Medtronic MiniMed

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

MiniMed 670G Insulin Pump
Model: MMT-1780, MMT-1781, MMT-1782

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

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

Vk_20191125_03

25.06.2020 р.

Ethicon LLC

ETHICON PERMA-HAND
Model: EH7457G, EH7983G
Lot: JPM942, KL6991, LGM827, LEZ809, MMZ678

MD: Silk suture, sterile

DE-1
FR-1
IT-1

Vk_20200608_22

24.06.2020 р.

Wellspect HealthCare

LoFric Origo, 40cm
Model: 44310, 44316, 44414; Cat.: 4431060, 4431660, 4441460
Lot: 447036, 447564, 447670

MD: Single-administration urethral catheterization kit, single-use

DE-1
FR-1
IT-1

Vk_20200616_13

23.06.2020 р.

Stryker Medical

Lifepak 500
Model: 99401-XXXX

MD: External defibrillator electrode, paediatric, single-use

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

Vk_20200617_12

10.06.2020 р.

(Updated 19.06.2020 р.)

Roche Molecular Systems Inc.

MagNA Pure 96 System
Model: 06541089001

IVD: Nucleic acid sample preparation instrument IVD, automated

DE-1
FR-1
EN-1

Vk_20200605_22

10.06.2020 р.

(Updated 19.06.2020 р.)

Siemens Healthcare Diagnostics Products Limited

PRISCA Prenatal Risk Calculation Software
Model: PRISCA 5 (SMN #10470386, 10484426, 10475998)
Lot: N/A
S/N: N/A
SW-Version: 5.0.0, 5.0.1, 5.0.2, 5.1.0, 5.2.0

IVD: Congenital defect/syndrome risk assessment interpretive software

IT-1
EN-1

Vk_20200605_19

15.06.2020 р.

(Updated 19.06.2020 р.)

OCON Medical Ltd.

IUB Ballerine Intrauterine Device
Model: IUB Ballerine MIDI;SCu00B
S/N: NA

MD: Intrauterine device, metal-covered

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

Vk_20200602_01

19.06.2020 р.

arcomed ag

Volumed VP7000 PREMIUM
Model: NA
Lot: all before June 2020
S/N: all

Volumed VP7000 Chroma
Model: NA
Lot: all before June 2020
S/N: all

MD: General-purpose infusion pump, line-powered

MD: General-purpose infusion pump, line-powered

DE-1
FR-1
EN-1

Vk_20200529_16

17.06.2020 р.

(Updated 18.06.2020 р.)

B. Braun Melsungen AG

SeQuent Please OTW
Model: all

MD: Peripheral angioplasty balloon catheter, drug-coated

DE-1
DE-Product List
FR-1
EN-1

Vk_20200616_01

15.06.2020 р.

(Updated 18.06.2020 р.)

KCI USA, Inc

ACTIV.A.C. Therapy Unit
Model: 340001

MD: Negative-pressure wound therapy system pump, electric

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

Vk_20200525_01

15.06.2020 р.

(Updated 18.06.2020 р.)

Lutonix Inc.

Lutonix 035 Drug Coated Balloon PTA Catheter
Model: See FSN

Lutonix 014 Drug Coated Balloon PTA Catheter
Model: See FSN

Lutonix 014 Drug Coated Balloon PTCA Catheter
Model: See FSN

MD: Peripheral angioplasty balloon catheter, drug-coated

MD: Peripheral angioplasty balloon catheter, drug-coated

MD: Peripheral angioplasty balloon catheter, drug-coated

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

Vk_20200505_13

10.06.2020 р.

(Updated 17.06.2020 р.)

Coltene/Whaledent, lnc.

HYGENIC Dental Dam Forceps
Model: H02778, H02790, H01262
Lot: H01262 – J44177, J73572, J73785, H02778 – J28716, J38282, J47108, J67133, J72691, H02790 – J74184, J74546

MD: Dental dressing forceps, reusable

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

Vk_20200609_01

16.06.2020 р.

Life Vascular Devices (LVD) Biotech SL

iVascular luminor
Model: iVascular luminor 14m (BPDPC14M), iVascular luminor 18 (BPDPC18), iVascular luminor 35 (BPDPC35)

MD: Peripheral angioplasty balloon catheter, drug-coated

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

Vk_20200609_17

16.06.2020 р.

SEM-Plastomed GmbH

CO2-Messleitung
Model: 851/09010 (2726)
Lot: 120129

MD: Gas administration system

DE-1

Vk_20200604_06

16.06.2020 р.

B. Braun Melsungen AG

Easypump ST/LT
Model: all
Lot: all

MD: Elastomeric infusion pump system

DE-1
FR-1
IT-1

Vk_20200529_18

15.06.2020 р.

Hemoteq AG

Ranger Paclitaxel-Coated PTA Balloon Catheter
Model: All
Lot: All

Ranger SL OTW Paclitaxel-Coated PTA Balloon Catheter
Model: All
Lot: All

MD: Catheters, Vascular, Angioplasty, Balloon

MD: Catheters, Vascular, Angioplasty, Balloon

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

Vk_20200610_17

15.06.2020 р.

Medtronic Inc.

IN.PACT ADMIRAL
Model: All

IN.PACT PACIFIC
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_20200610_04

15.06.2020 р.

Cook Ireland Limited

Zilver PTX Drug-Eluting Peripheral Stent

MD: Drug-eluting femoral artery stent

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

Vk_20200610_03

15.06.2020 р.

The Spectranetics Corporation

Stellarex – OTW Drug-coated Angioplasty Balloon
S/N: Not Serial Number specific

MD: Peripheral angioplasty balloon catheter, drug-coated

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

Vk_20200610_02

15.06.2020 р.

Boston Scientific Corporation

ELUVIA Over-The-Wire (OTW) Drug-Eluting Vascular Stent System
Model: All
Lot: All

MD: Drug-eluting femoral artery stent, Peripheral vascular catheter

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

Vk_20200609_20

15.06.2020 р.

ArjoHuntleigh AB

Lifeguard
Model: LG 20, LG 50, LG 55
S/N: 6 683 devices within a serial number range P051594 – P0586124 and 300089372 – 300093430
SW-Version: Not applicable

MD: Hospital stretcher, manual

DE-1
FR-1
IT-1

Vk_20200603_04

15.06.2020 р.

Handicare AB

SwiftHook
Model: 70200008
S/N: All

MD: Patient Lift Hook

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

Vk_20200511_12

15.06.2020 р.

Biosensors Europe SA

BioPath 014

BioPath 035

MD: Peripheral angioplasty balloon catheter, drug-coated

MD: Peripheral angioplasty balloon catheter, drug-coated

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

Vk_20200409_13

15.06.2020 р.

Biotronik AG

Passeo-18 Lux

MD: Peripheral angioplasty balloon catheter, basic

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

Vk_20200409_12

23.10.2019 р.

(Updated 15.06.2020 р.)

Medtronic Inc.

MyCareLink Heart Mobile Application
Model: MSW003, MSW004

CareLink Programmer
Model: 2090
S/N: all

29901 EncoreTM Programmer
Model: 29901
S/N: all

CareLink Network Application Software 2491
Model: 2491

CareLink SmartSync Device Manager
Model: 24967, 24970A
S/N: 24967, 24970A

AIMD: App for mobile devices

AIMD: Cardiac pulse generator programmer

AIMD: Cardiac pulse generator programmer

AIMD: Implantable cardiac device management application software

AIMD: Implantable pacemaker analyser, intraoperative

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

Vk_20191003_14

12.06.2020 р.

Medtronic (Schweiz) AG

CareLink SmartSync Base
Model: 24970A
SW-Version: All software before version 3.2.01

CareLink SmartSync Patient Connector
Model: 24967
SW-Version: All software before version 3.2.01

AIMD: Cardiac pulse generator programmer

AIMD: Implantable pacemaker analyser, intraoperative

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

Vk_20200605_13

12.06.2020 р.

Teleflex Malaysia

Rusch TracFlex Plus Phonation Set, Cuffed
Lot: See Appendix of attached FSN
S/N: n/a

MD: Basic tracheostomy tube, single-use

DE-1
FR-1
IT-1

Vk_20200515_08

17.10.2018 р.

(Updated 12.06.2020 р.)

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

Vk_20181015_09

11.06.2020 р.

Elekta Instrument AB

Leksell Vantage Arc System
Model: 1053958
S/N: see FSN

MD: Neurological stereotactic surgery system

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

Vk_20200608_12

11.06.2020 р.

ELECTRONIC CONCEPT LIGNON INNOVATION – ECLI

PHENIX PORTABLE & PHENIX CONTACT product range
S/N: All the serial numbers starting with the two (2) following letters : « CA », « CB », « DA », « CC », « CE », « CF », « CG », « DF »

MD: Physical therapy transcutaneous neuromuscular electrical stimulation system

FR-1
IT-1
EN-1

Vk_20200604_01

03.06.2020 р.

(Updated 11.06.2020 р.)

Biomedica Medizinprodukte GmbH & Co KG

Anti-C4d
Model: BI-RC4D
Lot: RCD191, RCD191C

IVD: Primary antisera for immunohistology

DE-1
EN-1

Vk_20200526_15

10.06.2020 р.

GE Medical Systems Information Technologies, Inc.

Patient Data Module
SW-Version: v 2.6 and v 2.7

MD: Patient monitoring system module, multifunction

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

Vk_20200603_36

03.06.2020 р.

(Updated 10.06.2020 р.)

Ortho Clinical Diagnostics Inc.

VITROS 5600
Model: 6802413; 6802915
SW-Version: 3.3.3 and below

VITROS 3600
Model: 6802783; 6802914
SW-Version: 3.3.3 and below

VITROS XT7600
Model: 6844461
SW-Version: 3.5.1 and below

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Multiple clinical chemistry analyser IVD, laboratory, automated

DE-1
EN-1

Vk_20200527_04

11.12.2019 р.

(Updated 10.06.2020 р.)

ResMed Ltd.

Stellar
Model: 100, 150; 24141, 24142, 24143, 24144, 24145, 24151, 24152, 24153, 24154, 24155
S/N: 20160123307 to 22171057208

MD: Portable electric ventilator

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

Vk_20191205_17

09.06.2020 р.

Galil Medical Ltd.

IceFORCE & IcePearl 2.1 CX Cryoablation Needles
Model: See Field Safety Notice
Lot: See Field Safety Notice

MD: Cryosurgical set

DE-1
EN-1

Vk_20200605_02

03.06.2020 р.

(Updated 09.06.2020 р.)

Prodimed

Sterile single use medical devices
Model: see product list
Lot: see product list

MD: various catheters, needles, drainage devices, anaesthesia kit

DE-1
FR-1
IT-1
EN-1
EN-Product List

Vk_20200529_17

09.06.2020 р.

TR Equipment AB

TR9650 patient lift
Model: 0542000, 0542010, 0542020
S/N: from 1203-20410 to and including 1501-22465

MD: Mobile patient lifting system, battery-powered

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

Vk_20200515_11

08.06.2020 р.

Gebr. Gloor AG

SWISS optio Y-Manifold
Model: PM9100-300420; GM91xx
Lot: All

MD: Manifolds, Gas

DE-1
FR-1
EN-1

Vk_20200602_17

08.06.2020 р.

Gebr. Gloor AG

SWISS optio reduc LP
Model: GM43xx
S/N: 00985, 02375, 01168, 02811, 02321, 02322, 02467, 02468, 02469, 02470, 02471, 02472, 02473, 02500, 02501, 02512, 02513, 02514, 02515, 02516, 02517, 02518, 02533, 02534, 02499

MD: Regulators

DE-1
FR-1
EN-1

Vk_20200602_16

08.06.2020 р.

Gebr. Gloor AG

SWISS optio jetflow
Model: GM4100

MD: Flowmeters, Gas

DE-1
FR-1
EN-1

Vk_20200602_15

08.06.2020 р.

Mathys Ltd Bettlach

optimys Rasp Handle double offset left
Model: 51.34.0112
Lot: 2242338; 2242339

MD: Joint prosthesis implantation kit, reusable

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

Vk_20200529_13

29.05.2020 р.

(Updated 05.06.2020 р.)

Stryker Medical

INFANT CHILD REDUCED ENERGY ELECTRODES
Model: See FSN
Lot: See FSN

MD: External defibrillator electrode, paediatric, single-use

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

Vk_20200525_33

04.06.2020 р.

DiaSys Diagnostic Systems GmbH

Creatinine PAP FS
Model: 1 1759¿
Lot: all

Uric acid FS TBHBA
Model: 1 3021¿
Lot: all

IVD: Creatinine kit

IVD: Enzymes

DE-1
FR-1
EN-1

Vk_20200423_13

03.06.2020 р.

Life Technologies Corporation, a part of Thermo Fisher Scientific

Applied Biosystems – COVID-19 Interpretive Software
Model: 100093007; version 1.0 and 100093343; version 1.1
Lot: not applicable
S/N: not applicable
SW-Version: version 1.0 and version 1.1

IVD: SARS-CoV-2 nucleic acid IVD, kit

EN-1

Vk_20200603_02

03.06.2020 р.

SEBAG SENECTOVIA Medizinaltechnik AG

Phoenix Ergocare Intensiv-Pflegebett
S/N: 17-12-PHO4172003 bis 19-09-PHO41712034; 19-11-PHO01CH0051 bis 19-11-PHO01CH0067

MD: Beds

DE-1

Vk_20200529_11

03.06.2020 р.

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Bedside to Patient Unit Cable (PURU3)
Model: 2020011;2020011
Lot: S1826001, S1815001, S1819001, S1833001, S1843001, S1845001, S1902001, S1912001, S1917001, S1934001
SW-Version: NA

MD: Polysomnograph

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

Vk_20200525_20

29.05.2020 р.

(Updated 03.06.2020 р.)

GROUPE SEBBIN SAS

Mammary Sizer
Model: GAB XXX

MD: Sizer for mammary implant

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

Vk_20200525_08

29.05.2020 р.

(Updated 03.06.2020 р.)

GROUPE SEBBIN SAS

Mammary Implants
Model: LS5X, LS7X, LS9X, LSMXX, LSAXX

MD: Silicone Implant and Expanders

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

Vk_20200525_06

26.05.2020 р.

(Updated 02.06.2020 р.)

Abbott Diabetes Care Ltd

FreeStyle LibreLink App
Model: 71809-01
SW-Version: v2.4.1

MD: Percutaneous glucose monitoring system

DE-1.1
DE-1.2
FR-1.1
FR-1.2
IT-1

Vk_20200519_15

20.05.2020 р.

(Updated 02.06.2020 р.)

DiaSorin Molecular LLC

Simplexa HSV 1&2 Direct
Model: MOL2150
Lot: All lots of MOL2150 that were viable at the time of software v2.0 release (01-July-2019) and shipped to DiaSorin SpA.
SW-Version: LIAISION MDX Studio Software v2.0

Simplexa VZV Direct
Model: MOL3650
Lot: All lots of MOL3650 that were viable at the time of software v2.0 release (01-July-2019) and shipped to DiaSorin SpA.
SW-Version: LIAISION MDX Studio Software v2.0

Simplexa VZV Swab Direct
Model: MOL3655
Lot: All lots of MOL3655 that were viable at the time of software v2.0 release (01-July-2019) and shipped to DiaSorin SpA.
SW-Version: LIAISION MDX Studio Software v2.0

IVD: Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
EN-1

Vk_20200513_08

29.05.2020 р.

Beiersdorf AG

Hansaplast Sensitive
Model: GTIN 4005800402968
Lot: 01624324, 01714443, 01714448

Hansaplast Elastic
Model: GTIN 4005800174612
Lot: 01434235, 01624322

MD: GTIN 4005800174612

MD: GTIN 4005800402968

DE-1
FR-1
IT-1

Vk_20200528_11

29.05.2020 р.

GROUPE SEBBIN SAS

Silicone implants, Skin expanders
Model: see fsn

MD: Silicone implant and expanders

EN-1

Vk_20200525_07

20.05.2020 р.

(Updated 29.05.2020 р.)

Siemens Healthcare Diagnostics Inc

Immulite 2000
Model: 10380062
Lot: N/A
S/N: N/A
SW-Version: N/A

Immulite 2000XPi
Model: 10373214
Lot: N/A
S/N: N/A
SW-Version: N/A

IVD: Immunoassay analyser

IVD: Immunoassay analyser

DE-1
FR-1
EN-1

Vk_20200518_09

28.05.2020 р.

Philips Goldway (Shenzhen) Industrial Inc.

CTG7 fetal/maternal monitor
Model: 866084

MD: Foetal cardiac monitor

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

Vk_20200130_06

27.05.2020 р.

Elekta Global Post Market Surveillance

Elekta Unity

MD: Linear accelerator system

FR-1
EN-1

Vk_20200525_05

27.05.2020 р.

Biomet Orthopaedics, LLC

TiMAX Large Cannulated Screw System – Outer Sheath
Model: 14235
Lot: all Lots

TiMAX Large Cannulated Screw System – Screw Instrument Tray
Model: 246111003
Lot: all Lots

MD: Orthopaedic implantation sleeve, reusable

MD: Instrument tray

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

Vk_20200525_02

27.05.2020 р.

concile GmbH

Infect/Cardio CRP
Model: C12-CRP20
Lot: 20180903, 20181009, 20181011, 20181102, 20190202; 20180905, 20181008, 20181201, 20181204, 20181212, 20190303, 20190310, 20190405, 20190411, 20190603, 20190705, 20190804, 20190901, 20191003, 20191201

IVD: Other Other Infectious Immunology

DE-1

Vk_20200520_23

26.05.2020 р.

Abbott Diabetes Care Ltd

FreeStyle Libre 2 Flash Glucose Monitoring System
Model: 71988-01
Lot: See FSN

MD: Percutaneous glucose monitoring system

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

Vk_20200525_19

26.05.2020 р.

Zimmer GmbH

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

MD: Shoulder glenoid fossa prosthesis, prefabricated

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

Vk_20200519_01

26.05.2020 р.

Hocoma AG

LokomatPro
Model: 30682

MD: Treadmill/elliptical gait rehabilitation system, automated-guidance

EN-1

Vk_20200518_31

20.05.2020 р.

(Updated 25.05.2020 р.)

Ortho-Clinical Diagnostics Inc.

VITROS Chemistry Product AMYL Slides Reagent
Model: 1202670 and 8112724
Lot: All lots from Product Coatings: 0349, 0356, 0357, 0358, 0359, 0362, 0363, 0365
S/N: Not Applicable
SW-Version: Not Applicable

IVD: Total amylase IVD, reagent

DE-1
EN-1

Vk_20200514_04

19.05.2020 р.

(Updated 25.05.2020 р.)

Abbott

Alinity c Processing Module
Model: 03R67-01
S/N: All

IVD: Multiple clinical chemistry analyser IVD, laboratory, automated

DE-1
EN-1

Vk_20200514_01

19.05.2020 р.

(Updated 25.05.2020 р.)

Siemens Healthcare Diagnostics Inc.

Atellica IM 1600
Model: 11066000
Lot: N/A
S/N: N/A
SW-Version: N/A

Atellica IM 1300
Model: 11066001
Lot: N/A
S/N: N/A
SW-Version: N/A

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1
FR-1
EN-1

Vk_20200512_06

13.05.2020 р.

(Updated 24.05.2020 р.)

Radiometer Medical ApS

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

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

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

Vk_20200506_19

13.05.2020 р.

(Updated 23.05.2020 р.)

Siemens Healthcare Diagnostics Inc

ADVIA Chemistry, Atellica CH Fructosamine
Model: see FSNs
Lot: all

Enzymatic Creatinine (Atellica, ADVIA, Dimension, Dimension Vista systems)
Model: see FSNs
Lot: all

IVD: Fructosamine IVD, kit, enzyme spectrophotometry

IVD: Creatinine IVD, kit, enzyme spectrophotometry

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

Vk_20200507_14

20.05.2020 р.

Dräger Medical AG & Co. KGaA

Breathing system VentStar Helix Heated
Model: see FSN
Lot: see FSN

MD: Tubing

DE-1

Vk_20200518_01

20.05.2020 р.

Philips Medical Systems DMC GmbH

TraumaDiagnost
Model: 70411, 704030, 72001, 720011, 720013, 720020, 720050

MD: X-ray system, diagnostic, general-purpose

DE-1
EN-1

Vk_20200512_08

20.05.2020 р.

TRUMPF Medizin Systeme GmbH + Co. KG

TruSystem 7500 SF/SB
Model: 1717023

MD: Line-powered electromechanical operating table system

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

Vk_20200508_14

11.05.2020 р.

(Updated 20.05.2020 р.)

Endologix Inc.

Ovation Abdominal Stent Graft System Platform
Model: TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I
Lot: See FSN
S/N: See FSN

MD: Abdominal aorta endovascular stent-graft

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

Vk_20200506_20

13.05.2020 р.

(Updated 20.05.2020 р.)

Apyx Medical Corporation

Renuvion/J-Plasma Precise & Precise Open Handpiece
Model: BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX-330BPS, APYX-150B, APYX-270B, APYX-330B, APYX-270BPP, APYX-330BPS,BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-044-BPP, APYX-150-BPP, APYX-150-BPS
Lot: all lots within expiration date
SW-Version: N/A

MD: Electrosurgical system

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

Vk_20200422_06

19.05.2020 р.

Datex-Ohmeda Inc.

Giraffe OmniBed
Model: see FSN

Giraffe Incubator
Model: see FSN

MD: Conventional infant incubator

MD: Conventional infant incubator

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

Vk_20200518_32

19.05.2020 р.

Tosoh Corporation

AIA-900
Model: N/A
Lot: N/A
S/N: 10122602 and after, 10122502 and before if LQC board was changed to V2
SW-Version: N/A

IVD: Enzyme immunoassay (EIA) analyser

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

Vk_20200515_10

19.05.2020 р.

Philips Medical Systems

Internal Sterilizable Defibrillator Paddles
Model: M1741A, M1742A, M1743A, M1744A, M4741A, M4742A, M4743A, M4744A

MD: Internal defibrillator electrode, adult

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

Vk_20200513_11

19.05.2020 р.

Abbott

MERLIN PATIENT CARE SYSTEM (PCS)
Model: 3650
SW-Version: 25.0.2 Rev 3

AIMD: Cardiac pulse generator software

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

Vk_20200512_07

13.05.2020 р.

(Updated 18.05.2020 р.)

Phadia AB

EliA Stool Extraction Kit
Model: 14-5638-01, 14-5651-01
Lot: 14-5638-01: 0236, 0237, 0238; 14-5651-01: 0293, 0295, 0299, 0300, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0309.

IVD: Calprotectin IVD, kit, enzyme immunoassay (EIA)

DE-1
EN-1

Vk_20200511_13

12.05.2020 р.

(Updated 18.05.2020 р.)

Stereotaxis, Inc.

Niobe ES
Model: 3.2; 001-006000-1, 001-006100-1
SW-Version: All

MD: Robotic surgical navigation system

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

Vk_20200511_01

06.05.2020 р.

(Updated 18.05.2020 р.)

VivaChek Laboratories, Inc.

VivaDiag COVID-19 lgM/lgG Rapid Test
Model: VID35-08-011
Lot: E2002002, SE2003001; SE2003002, SE2003003

IVD: Rapid Tests & Point of Care – Infectious Immunology

DE-1
FR-1
EN-1

Vk_20200428_11

06.05.2020 р.

(Updated 17.05.2020 р.)

DIALAB GmbH

Uric Acid TBHBA, Enzymatic,colorimetric
Model: D95459, D98461, D00463, D00464, D83911, D0441917, DA0847, DT1047, DK0744
Lot: 150120, 150519, 150419, 150319, 150219, 150119, 150518

IVD: Uric Acid

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

Vk_20200505_01

13.05.2020 р.

(Updated 15.05.2020 р.)

Teleflex Malaysia

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

MD: Basic tracheostomy tube, single-use

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

Vk_20200507_06

15.05.2020 р.

Sunrise Medical GmbH

Quickie Q700 UP M
S/N: see FSN (EN)

Quickie Q700 UP F
S/N: see FSN (EN)

MD: Wheelchair, powered

MD: Wheelchair, powered

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

Vk_20200506_12

15.05.2020 р.

Sterisets Medical Products

Abdominal Swabs, X-Ray Detectable
Model: 5610755D
Lot: 1908036

MD: Non-woven gauze pad, sterile

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

Vk_20200423_10

14.05.2020 р.

B.Braun Avitum AG

xevonta Hi 18
Model: 7204657
Lot: 140130120, 140190220, 140350320

MD: Hollow-fibre haemodialysis dialyser, single-use

DE-1
FR-1
IT-1

Vk_20200507_08

14.05.2020 р.

Gebrüder Martin GmbH & Co. KG

smartDrive screwdrivers T5/T6
Model: 26-975-33-07, 26-975-36-07, 26-975-37-07, 26-975-38-07, 26-975-39-07, 26-975-40-07

MD: Surgical screwdriver, reusable

DE-1
FR-1

Vk_20200430_19

31.03.2020 р.

(Updated 14.05.2020 р.)

Respironics California, LLC

V60 Ventilator
Model: V60
Lot: NA
S/N: See fsn
SW-Version: 2.10 and 2.30

MD: Portable electric ventilator

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

Vk_20200330_04

30.04.2019 р.

(Updated 14.05.2020 р.)

Edwards Lifesciences LLC

EV1000 Clinical Platform System
Model: EV1000A, EV1000NI
S/N: ALL

MD: Patient monitoring system

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

Vk_20190424_07

13.05.2020 р.

Biosense Webster Inc

PentaRay Nav Catheter
Model: D128201, D128202, D128203, D128204, D128205, D128206
Lot: all

PENTARAY NAV ECO CATHETER
Model: D128207, D128208, D128209, D128210, D128211, D128212
Lot: all

MD: Cardiac mapping catheter, percutaneous, single-use

MD: Cardiac mapping catheter, percutaneous, single-use

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

Vk_20200507_09

13.05.2020 р.

INTEGRA MICRO FRANCE SAS

Integra MicroFrance Monopolar Electrosurgical
Lot: 4472978 ; 4472979; 4472976; 4472977; 4472977; 4472958; 4472958; 4475986; 4475986; 4475980 ; 4483144; 4472956; 4472956; 4498337; 4472968 ; 4483135 ; 4483142; 4470569; 4470569; 4513621; 4513655; 4513627 ; 4516135; 4472971
S/N: CEV229-1A; CEV229B; CEV230-1; CEV82291; CP390-3; CP390-5; CP390-7; CP390-8; CP390L26 ; CP605M ; MCEN100-2-0 ; MCEN100-2-5 ; MCEN100-3-0 ; MCEN100-3-5; MCEN11; MCL219;MCL241; MCL241-1; MCL62

MD: Open-surgery electrosurgical electrode, monopolar, reusable

DE-1
FR-1
IT-1

Vk_20200506_06

24.03.2020 р.

(Updated 13.05.2020 р.)

Promedon S.A.

VANTRIS VUR Treatment
Model: BAR 1J

MD: Tissue Reconstructive Materials, Fluid

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

Vk_20200317_13

12.05.2020 р.

Philips Medical Systems Nederland BV

Zenition 50
Model: 718096
S/N: See FSN

Zenition 70
Model: 718133
S/N: See FSN

MD: Mobile general-purpose fluoroscopic x-ray system, digital

MD: Mobile general-purpose fluoroscopic x-ray system, digital

DE-1
EN-1

Vk_20200511_02

12.05.2020 р.

Elekta Ltd

Elekta Unity
S/N: 600001 – 600043

MD: Linear accelerator system

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

Vk_20200507_07

12.05.2020 р.

Elekta Ltd

Elekta Unity
S/N: 600014, 600016 – 600035

MD: Linear accelerator system

FR-1
IT-1
EN-1

Vk_20200506_08

12.05.2020 р.

Gambro Dasco S.p.A.

ARTISET PREPOST
Model: 955077
Lot: 1000226121, 1000206878, 1000208251, 1000226691, 1000204803, 1000204804, 1000218876, 1000210326, 1000198924

ARTISET HD DNL HC
Model: 955075
Lot: 1000226708

MD: Haemodialysis blood tubing set, single-use

MD: Haemodialysis blood tubing set, single-use

DE-1
IT-1

Vk_20200505_18

12.05.2020 р.

Karl Storz SE & Co.KG

Low pressure tube, for the central CO2 gas supply
Model: UI001, UI002 und UI003
Lot: all

MD: Insufflation gas conditioning tubing set

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

Vk_20200302_10

08.05.2020 р.

Philips Medical Systems

Pneumograph, chest, NM, 3160
Model: 94023
Lot: na

MD: Pneumograph

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

Vk_20200428_09

08.05.2020 р.

Siemens Healthcare GmbH

ARTIS pheno systems

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20200423_09

07.05.2020 р.

Philips Medical Systems

Heartstart XL Defibrillator/ Monitor
Model: M4735A
SW-Version: A.02.23

MD: Rechargeable professional automated external defibrillator

DE-1
FR-1
EN-1

Vk_20200507_10

07.05.2020 р.

Siemens Healthcare GmbH

Mammomat Revelation
Model: 11343300
S/N: See FSN

MD: Stationary mammographic x-ray system, digital

DE-1
FR-1

Vk_20200501_01

06.05.2020 р.

Smith & Nephew, Inc.

R3 Acetabular Shells
Model: Please see FSN Appendix 1.
Lot: Please see FSN Appendix 2.

MD: Acetabular shell

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

Vk_20200428_04

06.05.2020 р.

Abbott

ARCHITECT iGentamicin Reagent Kit
Model: 1P31-25
Lot: all

IVD: Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20200427_06

05.05.2020 р.

GE Medical Systems Information Technologies, Inc.

Carescape One

MD: Patient monitoring system module, multifunction

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

Vk_20200430_20

05.05.2020 р.

Medtronic Inc.

TriageHF Data Calculation Module (DCM)
Model: 5242
SW-Version: CLN17

MD: Implantable cardiac device management application software

FR-1
EN-1

Vk_20200429_09

05.05.2020 р.

Becton, Dickinson & Company

BD BBL Gram Stain Kit
Model: 212539
Lot: see FSN

BD BBL Gram Crystal Violet 3.8L
Model: 212526
Lot: see FSN

BD BBL Gram Crystal Violet 250mL
Model: 212525
Lot: see FSN

IVD: Biological stain solution kit IVD

IVD: Biological stain solution kit IVD

IVD: Biological stain solution kit IVD

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

Vk_20200428_10

 

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