Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2020 – 29.02.2020

Опубліковано 02.03.2020 о 13:37

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

 

7.01.2020

Hermann Bock GmbH

practico alu plus
Model: 423
S/N: 91905420-028

MD: Beds, Electric

DE-1
FR-1

Vk_20191213_17

27.12.2019 

(Updated 06.01.2020)

W.L. Gore & Associates

GORE EXCLUDER AAA Endoprosthesis
Model: See attachment

GORE EXCLUDER Iliac Branch Endoprosthesis
Model: See attachment

MD: Abdominal aorta endovascular stent-graft

MD: Iliac Branch endovascular stent-graft

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

Vk_20191219_26

03.01.2020

Karl Storz Endoskope SE und Co. KG

Autocon
Model: UH300, UH300U, UH400, UH400U, UH401, UH401U
S/N: all

MD: Electrosurgical system generator

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

Vk_20191219_19

18.12.2019 

(Updated 29.01.2020)

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

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

IVD: IVD kits for the detection of various pathogens

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

Vk_20191216_14

28.01.2020

GE Medical Systems Information Technologies, Inc.

ApexPro Telemetry System

Clinical Information Center (CIC) Pro

Carescape Central Unit

MD: Electrocardiography telemetric monitoring system

MD: Patient monitoring system central station monitor

MD: Patient monitoring system central station monitor

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

Vk_20200127_22

28.01.2020

Datex-Ohmeda Inc.

Giraffe Blue Spot PT Lite
S/N: See FSN

MD: Overhead infant phototherapy unit

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

Vk_20200127_01

28.01.2020

LiNA Medical ApS

Telescopic Smoke Evacuation Pencil
Model: SHK-TSP-CL, SHK-TSPL
Lot: 1923011, 1923050, 1924004, 1924005, 1924015, 1929038, 1929039, 1929055, 1922042, 1924003, 1929040, 1929048

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

DE-1
FR-1
IT-1

Vk_20200116_10

02.04.2019 

(Updated 27.01.2020)

Fresenius Medical Care AG & Co. KGaA

Granumix plus
Model: F00003333

DIAMIX
Model: 8002571, 8001571, 8004571, 8003571, 8006571, 8005571, 8008571, 8009571, F00001840, F00004888, F00003372, F00003384, F00003386

MD: Haemodialysis system fluid mixer

MD: Haemodialysis concentrate

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

Vk_20190329_03

29.01.2019 

(Updated 27.01.2020)

MAQUET Cardiovascular LLC

AXIUS Blower Mister
Model: CB-1000
Lot: 96255605, 96255607, 96255608, 96255609, 96255611; Expanded lot numbers: 96255614, 96255615, 96255616, 96255617, 96255618, 96255619, 96255620, 96255621, 96255622, 96255623

MD: Surgical irrigation tubing set, single-use

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

Vk_20190128_05

24.01.2020

SOPRO

PSPIX
Model: PSPIX
S/N: OJ1208174 to OJ1314402

MD: Radiography digital imaging scanner

EN-1

Vk_20200120_03

24.01.2020

Caesarea Medical Electronics Limited

T34 TM Ambulatory Syringe Pump
Lot: All lots
SW-Version: N/A

MD: Syringe pump

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

Vk_20200116_01

24.01.2020

Mathys Ltd Bettlach

Affinis PE glenoid
Model: 60.30.3039
Lot: 2267919
S/N: N/A
SW-Version: N/A

MD: Artificial shoulder joint

DE-1
FR-1
EN-1

Vk_20200115_01

24.01.2020

Philips Medical Systems DMC GmbH

CombiDiagnost R90
Model: 709030
Lot: NA
S/N: 10000011, SN17000124, SN18000069, SN18000012, SN17000126, SN17000132
SW-Version: NA

MD: Radiographic/fluoroscopic unit, mobile

FR-1
EN-1

Vk_20200108_03

03.01.2020 

(Updated 24.01.2020)

Schiller Medical SAS

DEFIGARD TOUCH7
Model: 1-128-9620, 1-128-9622, 1-128-9624, 1-128-9625
S/N: All
SW-Version: 07.B07

MD: Physiologic-monitoring defibrillation system

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

Vk_20191213_16

24.01.2020

Medline International France SAS

Fluid collection pouches with graduations used on maternity drapes
Model: See FSN
Lot: See FSN

MD: Sterile Procedure Pouches and Packs

FR-1
EN-1

Vk_20191209_11

24.01.2020

AIR LIQUIDE MEDICAL SYSTEMS

MONNAL T50
Model: see FSN
Lot: See FSN
SW-Version: V2.6.1

MD: Neonatal/adult intensive-care ventilator

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

Vk_20191011_03

21.01.2020 

(Updated 23.01.2020)

Olympus Medical Systems Corp.

OLYMPUS PLEURAVIDEOSCOPE
Model: LTF-160; N1030060, N3634160, N4500660
S/N: All

MD: Rigid video laparoscope

DE-1
EN-1

Vk_20200114_19

30.07.2019 

(Updated 23.01.2020)

Siemens Healthcare Diagnostics Products Limited

IMMULITE/IMMULITE 1000 Progesterone
Model: LKPW1
Lot: all

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

IVD: Progesterone IVD, kit, chemiluminescent immunoassay

IVD: Progesterone IVD, kit, chemiluminescent immunoassay

EN-1
EN-2

Vk_20190723_14

20.02.2018 

(Updated 23.01.2020)

PACIFIC MEDICO

PMH 7000 Series
Model: 7000000, 7000002, 7000003, 7000007, 517106, 517115, 517146, 517152, 517154, 517158
Lot: see FSN
S/N: all

MD: Humidifier, heat/moisture exchange

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

Vk_20180115_03

22.01.2020

Philips Medical Systems Nederland BV

Integris CV, Allura CV
Model: See FSN

Allura Xper
Model: See FSN

OmniDiagnost Eleva
Model: See FSN

MultiDiagnost Eleva with Flat Detector
Model: See FSN

Allura Centron
Model: See FSN

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

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

Vk_20200120_01

22.01.2020

Radiometer Medical ApS

ABL90 FLEX
Model: 393-090
SW-Version: below V3.4 MR2

ABL90 FLEX PLUS
Model: 393-092
SW-Version: below V3.4 MR2

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

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

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

Vk_20200116_14

22.01.2020

SenoRx, Inc.

EnCor Breast Biopsy Probe
Model: ECP017G, ECPMR0110G, ECPMR0110GBT, ECPMR017G
Lot: VTCT0268, VTCT0269, VTCT0270, VTCT0271, VTCU0340, VTCU0341, VTCW0468, VTCV0370, VTCT0272, VTCV0384

MD: Mammographic stereotactic biopsy system

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

Vk_20200110_10

14.01.2020 

(Updated 22.01.2020)

Bard Access Systems Inc

BARD Site~Rite 8 Ultrasound System
Model: 9770550
Lot: All serial numbers

MD: General-purpose ultrasound imaging system

DE-1
FR-1
IT-1

Vk_20200109_11

03.01.2020 

(Updated 22.01.2020)

EDEN INNOVATIONS

DOC
Model: Fixed and Mobile; DOCxxx yyyyy
S/N: See FSN

MD: Accessory of Philips HS1 defibrillator

FR-1-Distributeur
FR-1-Utilisateur
IT-1-Distributori
EN-1-Distributor

Vk_20191223_43

21.01.2020

Phoenix s.r.l

Volumed Set
Model: APTPK0J
Lot: 19PH427

MD: Infusion Set with or without Air Inlet

DE-1
EN-1

Vk_20200116_03

21.01.2020

Medline Industries Inc.

SURGICAL CLIPPER HANDLE & CHARGER BASE, EU PLUG
Model: DYND70800EU, DYND70802EU
Lot: LOT numbers less than: 8051707XXXX for DYND70800EU, 8051707XXXX for DYND70802EU
SW-Version: N/A

MD: Surgical hair clippers

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

Vk_20200115_13

16.01.2020 

(Updated 21.01.2020)

ArcRoyal Ltd

ArcRoyal Custom Procedure Trays containg insufflation tubing set with gas filter
Model: see FSN
Lot: see FSN

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

DE-1
FR-1
EN-1

Vk_20200108_07

17.01.2020

Peters Surgical

SINGLE USE MONOPOLAR CABLE
Model: CAB3000
Lot: All

MD: Electrical-only medical device connection cable, single-use

DE-1
FR-1
IT-1

Vk_20200109_02

17.01.2020

Peters Surgical

SINGLE USE MONOPOLAR SCISSORS – IN CUT
Model: C5330, T5150, C5250, T5330, IC5330, IK5330, C5470, CB5330
Lot: All

SINGLE USE MONOPOLAR FORCEPS – ENDOGRIP
Model: A5330, F5330, G5330, MD5330, D5330, FS5330, FS5470, MD5470
Lot: All

SINGLE USE MONOPOLAR HOOKS ¿ ENDOHOOK
Model: H5330, H5330L
Lot: All

MD: Endoscopic electrosurgical electrode, monopolar, single-use

MD: Endoscopic electrosurgical electrode, monopolar, single-use

MD: Endoscopic electrosurgical electrode, monopolar, single-use

DE-1
FR-1
IT-1

Vk_20200108_01

09.12.2019 

(Updated 17.01.2020)

Medtronic Navigation Inc.

O-arm O2 Imaging System
Model: BI-700-02000 O-arm O2 Base
S/N: See FSN

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

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

Vk_20191126_02

16.01.2020

Pfizer Consumer Healthcare

ThermaCare HeatWraps – Flexible Use
Lot: T48946

MD: Exothermic heat therapy pack/patch

DE-1
EN-1

Vk_20200110_09

15.01.2020

Siemens Healthcare Diagnostics Inc

Atellica IM 1300
SW-Version: Software versions 1.21.0 and lower

Atellica IM 1600
SW-Version: Software versions 1.21.0 and lower

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1
EN-1

Vk_20200113_06

15.01.2020

Philips Medical Systems Nederland BV

Philips Azurion system
Model: Philips VesselNavigator application when used with an Azurion system R1.2.x and R2.0.x; 722063, 722064, 722065, 722066, 7722067, 722068, 722078, 722079, 722302, 722303, 722136
Lot: NA

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

DE-1
EN-1

Vk_20200109_12

15.01.2020

GE Medical Systems LLC

1.5T SIGNA HDxt SIGNAWorks Edition (2019 upgrade for 1.5T SIGNA HDxt systems)
SW-Version: HD28

SIGNA Architect
SW-Version: DV26, DV28

SIGNA Pioneer, SIGNA Premier
SW-Version: PX28, RX28

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

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

Vk_20200109_10

14.01.2020

Agfa HealthCare

ORBIS Medication
SW-Version: 3.11.1 and higher

MD: Patient health record information system application software

DE-1
EN-1

Vk_20200110_04

14.01.2020

Borer Chemie AG

Deconex
Model: see FSN

MD: Detergent

EN-1

Vk_20191217_01

13.01.2020

Medtronic Inc.

Viva XT, Viva Quad XT, Viva QUAD A, Brava OUS, Brava QUAD, Amplia MRI Quad, Compia MRI, Evera MRI DR S, Evera MRI VR S, Evera XT, Evera S, Evera MRI, Visia AF S, Visia AF MRI S
Model: DTBA2D1, DTBA2D4, DTBA2Q1, DTBA2QQ, DTBC2D1, DTBC2D4, DTBC2Q1, DTBC2QQ, DTMB2D1, DTMC2D1, DDMC31, DVMC3D4, DDBB2D1, DDBB2D4, DDBC3D1, DDBC3D4, DDMC3D1, DVAC3D1, DVBC3D1, DVBC3D4, DVFC3D1, DVFC3D4
S/N: All devices manufactured using the part number M945899A002

AIMD: Single-chamber implantable defibrillator; Cardiac resynchronization therapy implantable defibrillator; Dual-chamber implantable defibrillator

DE-1
FR-1
IT-1

Vk_20191210_09

13.01.2020

Promedical AG

Kornzange
Model: 162173.1

MD: Forceps

DE-1
FR-1

Vk_20190729_22

09.01.2020

Smith & Nephew, Inc.

TWINFIX SUTURE ANCHOR
Model: 72200796
Lot: 2010547, 2025137, 2036695, 50763859, 50773071

MD: Tendon/ligament bone anchor, non-bioabsorbable

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

Vk_20200106_09

09.01.2020

Schwarzer Cardiotek GmbH

Evolution core
Model: 80EVL03 (80EVL00 evolution core + 00AMP03 Verstärker Option 3)
SW-Version: 4.3.3

MD: Cardiac catheterization laboratory computer

DE-1

Vk_20200103_09

20.12.2019 

(Updated 09.01.2020)

Leonhard Lang GmbH

GS defibrillation electrodes
Model: corPatch easy 04324.3
Lot: 190711-3993

MD: Electrodes, Cardiac, External Defibrillator

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

Vk_20191219_20

20.12.2019 

(Updated 09.01.2020)

Medtronic Sofamor Danek USA, Inc.

AsterX Expandable Corpectomy System
Model: see FSN
Lot: All

MD: Vertebral body prosthesis, non-sterile

DE-1
FR-1
EN-1

Vk_20191218_09

08.01.2020

Siemens Healthcare Diagnostics Inc

ADVIA Chemistry Lipase Reagent
Model: 10311896
Lot: 485700
S/N: N/A
SW-Version: N/A

IVD: Lipase kit

DE-1
EN-1

Vk_20200106_06

08.01.2020

Datascope Corp.

Reinforced Introducer Set
Model: 0684-00-0403-06 (Maquet 7Fr.), 0684-00-0403-05 (Maquet 7.5Fr), 0684-00-0403-10 (Maquet 8Fr)
Lot: 3000014728, 3000015016, 3000019781, 3000031711, 3000036631, 3000040290, 300004310, 3000043101, 3000051658, 3000053099, 3000079612, 3000079613, 30000868020, TLT, TTP, TTQ

MD: Intra-aortic balloon catheter

DE-1

Vk_20191211_15

08.01.2020

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
FR-1
IT-1
EN-1

Vk_20191202_22

08.01.2020

RaySearch Laboratories AB

RayStation
Model: RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan 7, RayStation/RayPlan 8A, RayStation/RayPlan 8B and RayStation/RayPlan 9A

MD: Radiation therapy software

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

Vk_20191126_06

08.01.2020

LiNA Medical ApS

Smoke Evacuation Pencil
Model: SHK-TSP, SHK-TSP-C, SHK-TSP-CL, SHK-TSPL, SHK-VS, SHK-VS-C, SHK-VS-CL, SHK-VS-C-NP, SHK-VS-C-NPL, SHK-VS-C-RS, SHK-VS-C-RSL, SHK-VS-C-SPT, SHK-VS-C-SPTL, SHK-VSL SHK-VS-NP, SHK-VS-NPL, SHK-VS-SPT, SHK-VS-SPTL
Lot: See attached product list

MD: Smoke Evacuation Pencil

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

Vk_20191025_12

07.01.2020

Avanos Medical, lnc.

Halyard Closed Suction System
Model: 195-5
Lot: M18268T402, M18274T402, M18290T402

MD: Suction system catheter, general-purpose

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

Vk_20200107_03

07.01.2020

Zytomed Systems GmbH

Rabbit anti-CDX2
Model: BRB028
Lot: X474

IVD: Primary antisera for immunohistology

EN-1

Vk_20200106_10

07.01.2020

Siemens Healthcare Diagnostics Inc

Enzymatic Creatinine (Atellica, ADVIA, Dimension, Dimension Vista systems)
Model: Atellica: 11097533, ADVIA: 04992596, Dimension: DF270B, Dimension Vista: K1270A
Lot: all
SW-Version: N/A

IVD: Creatinine IVD, kit, enzyme spectrophotometry

EN-1 (ADVIA)
EN-1 (Atellica)
EN-1 (Dimension Vista)
EN-1 (Dimension)

Vk_20200106_08

07.01.2020

Siemens Healthcare Diagnostics Inc

ADVIA Centaur NT-proBNP (PBNP)
Model: 10699449, 10699450
Lot: see FSN

Atellica IM NT-proBNP (PBNP)
Model: 11200588, 11200589
Lot: see FSN 022 and above

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

DE-1_ADVIA
DE-1_Atellica
FR-1_ADVIA
EN-1_ADVIA
EN-1_Atellic

 

19.02.2020 

(Updated 02.03.2020)

Diagnostica Stago

STA Compact
S/N: all
SW-Version: all

STA-R Evolution
S/N: see FSN
SW-Version: see FSN

STA Compact Max
SW-Version: see FSN

STA-R Max
SW-Version: see FSN

Factor VIII assays
Model: see FSN
Lot: all

IVD: Haematology analyser, coagulation

IVD: Haematology analyser, coagulation

IVD: Coagulation analyser IVD, laboratory, automated

IVD: Coagulation analyser IVD, laboratory, automated

IVD: Coagulation factor VIII

DE-1
EN-1

Vk_20200213_11

22.01.2020 

(Updated 02.03.2020)

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Patient Monitor
Model: VS-900, N12, N15, N17, N19
S/N: see FSN

MD: Single-patient physiologic monitoring system

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

Vk_20200115_08

28.02.2020

Life Fitness

Cybex Eagle Incline Press
Model: 11150
S/N: J061611150224M, H053111150132M, G101911150090M, G101911150089M, G091011150080M, G082311150071M, F1027111509712M, F0728111509083M, F0623111509076M, F0526111509071M, J071711150228M, H061311150133M, G051011150054M, G030611150040M

MD: Physikalische Therapie – Massagegeräte / Bewegungsgeräte

DE-1
EN-1

Vk_20200212_07

27.02.2020

Micro Therapeutics, Inc.

Pipeline Flex Embolization Device
Model: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX, PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-
Lot: See FSN

MD: Bare-metal intracranial vascular stent

DE-1
FR-1
EN-1

Vk_20200227_01

27.02.2020

Gambro Lundia AB

Prismaflex System
SW-Version: see FSN

MD: Haemodialysis system, institutional

DE-1
FR-1
EN-1

Vk_20200219_10

27.02.2020

Amplitude S.A.S.

EXTREME monobloc Epiphyseal-Metaphyseal with HAP
Model: 1-0107201, 1-0107202,1-0107203,1-0107204
Lot: All batches with an expiry date inferior to August 2024

MD: Revision coated hip femur prosthesis

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

Vk_20200218_01

26.02.2020

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

FTD FLU/HRSV
Model: FTD-48.1-32/ 10921784, FTD-48.1-64/ 10921785
Lot: All

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

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

Vk_20200221_12

26.02.2020

Siemens Healthcare Diagnostics Inc

Direct Bilirubin
Model: see FSN
Lot: all

Total Bilirubin
Model: see FSN
Lot: all

IVD: Conjugated (direct) bilirubin IVD, kit, spectrophotometry

IVD: Total bilirubin IVD, kit, spectrophotometry

DE-1_ADVIA
DE-1_Atellica
DE-1_Dimension
DE-1_Dimension Vista
FR-1_Dimension
FR-1_Dimension Vista
EN-1_ADVIA
EN-1_Atellica
EN-1_Dimension
EN-1_Dimension Vista

Vk_20200220_09

26.02.2020

Limacorporate S.p.a.

SMR Shoulder cementless finned stem L.80mm dia.19m
Model: 1304.15.190
Lot: 1906009 ster.1900213

MD: Press-fit shoulder humeral stem prosthesis

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

Vk_20200219_12

25.02.2020

Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis zeego, Artis zee, Artis Q, Artis Q.zen

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1

Vk_20200224_07

25.02.2020

Nextremity Solutions

Nextra Hammertoe Correction System
Model: NX-4532K
Lot: 168117318B

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

DE-1
FR-1

Vk_20200213_03

20.02.2020 

(Updated 25.02.2020)

Wöhlk Contactlinsen GmbH

CONTACT AIR spheric
Lot: 20390605400

MD: Contact Lenses, Vision Corrective

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

Vk_20200212_06

24.02.2020

Siemens Healthcare Diagnostics Products Limited

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

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

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

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

FR-1
EN-1

Vk_20200212_13

24.02.2020

Dermosciences France Sarl

Cosmo Peel Kit
Model: TCA 12, TCA 15, TCA 18, TCA 20
Lot: 17L001, 17L002, 17L003, 17L004

MD: Superficial skin exfoliant, professional

FR-1

Vk_20200124_08

24.02.2020

FCI S.A.S.

Purified silicone oil syringe
Model: S5.7570, S5.7170, S5.7560, S5.7160
Lot: See FSN

MD: Vitreous humour replacement medium, postoperative

DE-1
FR-1
IT-1

Vk_20200103_26

21.02.2020

Ethicon inc.

ETHIBOND EXCEL® Polyester Suture
Model: Please see Attachment “Product details”
Lot: Please see Attachment “Product details”
S/N: N/A
SW-Version: N/A

MD: Polyester suture, non-bioabsorbable, multifilament

FR-1
EN-1

Vk_20200213_07

21.02.2020

AAT – Alber Antriebstechnik GmbH

CAMILINO
Model: P1203
S/N: P1203190102, P1203190103, P1203190104, P1203190105, P1203190176, P1203190175, P1203190178, P1203190177

MD: Wheelchairs, Powered

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

Vk_20200212_03

19.02.2020

Dräger Medical AG & Co.

Oxylog VE300
Model: 5790200
S/N: See FSN

MD: Transport electric ventilator

DE-1

Vk_20200212_08

19.02.2020

Turon MedTech AB

CYTOGUIDE needle guide bushes
Model: GA12, GA14, GA16, GA18, GA20, GA20 Open, GA22
Lot: 040301, 040302, 040307, 040308, 040309, 040311, 040312

MD: Nonimplantable needle guide, single-use

DE-1
FR-1
EN-1

Vk_20200206_15

18.02.2020

Covidien LLC

Force TriVerse
Model: FT3000, FT3000DB
Lot: See FSN

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

DE-1
FR-1
IT-1

Vk_20200211_10

12.02.2020 

(Updated 18.02.2020)

R-Biopharm AG

RIDA QUICK Malaria Positive Control
Model: NP7004
Lot: 13369

IVD: Plasmodium falciparum

DE-1
EN-1

Vk_20200210_08

12.02.2020 

(Updated 18.02.2020)

Cook Endoscopy

Hemospray Endoscopic Hemostat
Model: HEMO-10-EU and HEMO-7-EU
Lot: see FSN
SW-Version: N/A

MD: Inorganic haemostatic agent, sterile

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

Vk_20200204_01

18.02.2020

Somnomedics GmbH

LIC2 Adhesive Electrode Cream
Model: SEN035/1, SEN035

MD: Physiologic Recording Systems

DE-1
FR-1

Vk_20200129_09

29.10.2019 

(Updated 18.02.2020)

Integra LifeSciences (Ireland) Ltd.

CUSA Clarity Console
Model: C7000
S/N: All

MD: Soft-tissue ultrasonic surgical system

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

Vk_20191028_03

17.02.2020

Neovasc Inc

Neovasc Reducer
Model: RED-001
Lot: 190131-01

MD: Bare-metal coronary artery stent

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

Vk_20200206_11

14.02.2020

Raymed Imaging AG

Raymat AS1
Model: AS1
Lot: see FSN

MD: Mounts

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

Vk_20200205_10

14.02.2020

PaloDEx Group Oy

Optime, GXPS-500, Express, Scan eXam
Model: 900267, 900266, 900469, 900270
Lot: Devices manufactured between April 2012 and November 2013
S/N: Optime: SJ1105219 – SJ1314421, GXPS-500: GJ1209488 – GJ1311722, Express: IJ1208217 – IJ1313309, Scan eXam: KJ1208178 – KJ1314403

MD: Radiography digital imaging scanner

DE-1
FR-1
IT-1

Vk_20200204_18

11.02.2020 

(Updated 14.02.2020)

Applied Medical Resources Corporation

Stealth, Surgical Spring Clip
Model: A1601, A1602, A1603
Lot: 1359929, 1360356, 1357103

MD: Vascular clamp, single-use

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

Vk_20200204_10

14.01.2020 

(Updated 14.02.2020)

PACIFIC MEDICO

PMH 7000 Series
Model: PMH 7000; 7000000, 7000002, 7000003, 7000007, 517106, 517115, 517146, 517152, 517154, 517158
S/N: All

MD: Humidifier, heat/moisture exchange

DE-1
IT-1
EN-1

Vk_20200114_01

05.02.2020 

(Updated 13.02.2020)

Accriva Diagnostics, Inc.

Hemochron Signature Elite
Model: ELITE; ELITEINT
Lot: N/A
S/N: All serial numbers with a software version 2.0, 2.1, 2.2, 2.3
SW-Version: 2.0, 2.1, 2.2, 2.3

IVD: Analyser, point-of-care, whole blood, coagulation

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

Vk_20200203_14

04.02.2020 

(Updated 13.02.2020)

HeartWare Inc.

HeartWare Battery Charger AC Adapter
Model: 1610, 1640
S/N: all

AIMD: Implantable ventricular circulatory assist system

DE-1
FR-1
EN-1

Vk_20200130_04

12.02.2020

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
FR-1
EN-1

Vk_20200210_11

11.02.2020

Siemens Healthcare GmbH

Ysio
Model: 10281013
SW-Version: VB10

MD: Stationary basic diagnostic x-ray system, digital

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

Vk_20200210_12

11.02.2020

Boston Scientific Corporation

IMAGER II Angiographic Catheter
Model: See FSN
Lot: See FSN

MD: Angiographic catheter, single-use

DE-1
EN-1

Vk_20200205_17

11.02.2020

Philips Medical Systems

Efficia Combined Cable/3-Leadset
Model: 989803160731, 989803160741, 989803160751, 989803160761

Efficia Combined Cable/5-Leadset
Model: 989803160771, 989803160781, 989803160791, 989803160801

MD: Electrocardiographic lead set, reusable

MD: Electrocardiographic lead set, reusable

EN-1

Vk_20200205_08

05.02.2020 

(Updated 10.02.2020)

Qiagen GmbH

Rotor-Gene Q
Model: see FSN
SW-Version: Rotor-Gene Q Software, Version 2.3.4

IVD: Nucleic Acid Testing Amplification Detection Instruments

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

Vk_20200203_04

10.02.2020

Stryker Endoscopy

SPY-PHI Drape
Model: HH2020; HH2000
Lot: See list attached

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

DE-1
FR-1
IT-1

Vk_20200121_10

30.12.2019 

(Updated 10.02.2020)

Datex-Ohmeda Inc.

Giraffe OmniBed
Model: see FSN

Giraffe OmniBed Carestation
Model: see FSN

Giraffe Incubator Carestation
Model: see FSN

Giraffe Incubator
Model: see FSN

MD: Conventional infant incubator

MD: Conventional infant incubator

MD: Conventional infant incubator

MD: Conventional infant incubator

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

Vk_20191223_30

07.02.2020

Teleflex Medical

Arrow EPIDURAL CATHETERIZATION Kits and Sets
Model: See FSN
Lot: See FSN

MD: Low-resistance syringe; Epidural/intrathecal anaesthesia set, non-medicated; Epidural needle, non-threaded; Epidural anaesthesia set, medicated; Epidural anaesthesia set, non-medicated; Vascular catheter introduction set, nonimplantable

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

Vk_20200131_01

07.02.2020

Wassenburg Medical B.V.

WASSENBURG DRY320 drying cabinet
S/N: All serial numbers

MD: Endoscope drying cabinet

DE-1
FR-1

Vk_20200130_05

06.02.2020

Ormco Corporation

Damon Q2 L#R .022 +13/+5/0 Hi TQ Hook
Model: 491-9834

MD: Orthodontic bracket, metal

DE-1
FR-1
EN-1

Vk_20200129_02

06.02.2020

Ormco Corporation

Snaplink Buccal Tube, 18° 0° 12°
Model: 438-2190 & 438-2191
Lot: All lots distributed since 2015

MD: Orthodontic tube

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

Vk_20200127_05

06.02.2020

Smith & Nephew Inc. Orthopedic Division

LEGION AP FEMORAL CUTTING BLOCKS
Model: 71434409, 71434411, 71434412, 71434413
Lot: 17LM05399, 17LM07852 & 17LM07852A; 17LM05397, 17LM05398 & 17LM07849; 17LM01746, 17LM05390, 17LM05394 & 17LM07851; 17LM08442

MD: Orthopaedic prosthesis implantation instrument, reusable

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

Vk_20200116_07

05.02.2020

TORNIER SAS

MoPyC Radial Head Prosthesis
Model: Impactor; IPTR011 or IPTR001

MD: Elbow radius prosthesis

DE-1
FR-1
IT-1

Vk_20200203_01

05.02.2020

Zimmer Surgical, Inc

Disposable Cylindrical Tourniquet Cuff
Model: 60708015200
Lot: 27968701

MD: Tourniquet cuff, single-use

DE-1
EN-1

Vk_20200131_02

05.02.2020

Abbott

Alinity ci-series System Control Module
Model: 03R70-01
S/N: all
SW-Version: Alinity ci-series SW version 2.6.2 and earlier

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1B
FR-1B
IT-1B
EN-1A (PM Algorithm)
EN-1B

Vk_20200128_04

05.02.2020

Dedienne Santé

DS EVOLUTION CEMENTLESS
Model: 52.34.0904
Lot: 132882380B

Symbol Cup
Model: 3700502204117; 3700502203561
Lot: 095858230D: 132882380A

Gyracup E Cementless
Model: 3700502203561
Lot: 132882400B

MD: Acetabular shell

MD: Acetabular shell

MD: Acetabular shell

EN-1

Vk_20200128_02

05.02.2020

Heraeus Medical GmbH

PALAMIX UNO
Model: 66057893
Lot: all

PALAMIX DUO
Model: 66057897
Lot: all

MD: Manual orthopaedic cement mixer, reusable

MD: Manual orthopaedic cement mixer, reusable

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

Vk_20200127_15

23.01.2020 

(Updated 05.02.2020)

Stryker Medical

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

MD: Physiologic-monitoring defibrillation system

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

Vk_20200113_03

04.02.2020

Shanghai Kindly Enterprise Development Group Co Ltd

Alaris Extension Sets, Low Sorbing (PE)
Model: 04105001509K, 04105003509K, 04105005509K, 04105007509K, 04105010509K, 04105025509K, G40215K, G40215K, G40615K, G40620K
Lot: See FSN

MD: Intravenous administration tubing extension set

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

Vk_20200203_19

04.02.2020

Siemens AG Medizinische Technik – AX

ARTIS pheno systems

MD: Stationary angiographic x-ray system, digital

DE-1
EN-1

Vk_20200129_11

04.02.2020

Dermosciences France Sarl

Mela Peel kit
Lot: L01, L02

Mela Peel Forte kit
Lot: BI001, FA001

MD: Superficial skin exfoliant, professional

MD: Superficial skin exfoliant, professional

FR-1

Vk_20200129_01

31.01.2020

Landanger

STERNAL RETRACTOR IMA
Model: DC30200-00
S/N: 00837436

MD: Self-retaining surgical retractor, reusable

EN-1

Vk_20200116_02

27.12.2019 

(Updated 31.01.2020)

RaySearch Laboratories AB

RayStation
Model: see FSN
Lot: see FSN

MD: Radiation therapy software

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

Vk_20191227_10

23.01.2020 

(Updated 31.01.2020)

Bischoff & Bischoff GmbH

Rollator
Model: 4003
S/N: D4003R000000135 to D4003R0000SSXXX

MD: Walking aid

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

Vk_20191219_23

21.01.2020 

(Updated 30.01.2020)

William Cook Europe ApS

Zenith Alpha Spiral-Z Endovascular Leg
Model: See FSN
Lot: All lots

MD: Synthetic vascular graft

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

Vk_20200115_07

29.01.2020

bioMérieux SA

VIDAS NT-proBNP2
Model: 30458
Lot: 1007679480, 1007679500

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20200128_01

29.01.2020

BioFire Diagnostics, LLC

FilmArray Blood Culture Identification (BCID) Panel
Model: RFIT-ASY-0127 / RFIT-ASY-0126

IVD: Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

EN-1

Vk_20200127_09

29.01.2020

Teleflex Medical

Pilling CLEAR ADVANTAGE
Model: 353440, DP-28K, DP-36K, DP-40K, DP-44K, DP-48K, DP-52K, DP-56K, DP-60K, MDP-28K, MDP-26K, MDP-40K, MDP-44K, MDP-48K, MDP-52K, MDP-56K, MDP-60K
Lot: see Appendix 2 in the FSN

MD: Aorta punch, single-use

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

Vk_20200127_02

29.01.2020

Siemens Healthcare GmbH, Diagnostic Imaging, X-Ray-Products

Ysio Max; Luminos dRF Max; Luminos Agile Max
Model: 10762470, 10762471, 10762472
Lot: n.a.
S/N: see attachment

Uroskop Omnia Max
Model: 10762473

MD: Stationary basic diagnostic x-ray system, digital

MD: Stationary uro-gynaecological fluoroscopic x-ray system, digital

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

Vk_20200122_12

29.01.2020

Teleflex Medical

Rusch GreenLite (Mac 4)
Model: 004551004
Lot: 1812341; 1903341

Rusch Green Lite (MAC 3)
Model: 004551003
Lot: 1811331; 1902331; 1904331

MD: Laryngoscope blade, single-use

MD: Laryngoscope blade, single-use

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

Vk_20200115_17

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