Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2018 – 30.09.2018

Опубліковано 08.10.2018 о 12:13

Швейцарія

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

 

18.09.2018

(Updated02.10.2018)

CooperSurgical Inc.

Lone Star Single-Use Elastic Stays 
Model: 3314-1G; 3316-1G; 3550-1G 
Lot: 244660, 244667, 244883, 244884, 245603, 245964, 245973, 246138, 248871, 250426, 251395

MD: Laparoscopic access cannula, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180917_02

11.09.2018

(Updated02.10.2018)

Bio-Rad France

Pastorex Meningitis 
Model: 61607 
Lot: 64160551 exp: 2019-01-22 64175493 exp: 2019-01-22 64169521 exp: 2019-03-16

IVD: Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

FR-1 
EN-1 
EN-2 

Vk_20180905_16

26.09.2018

(Updated28.09.2018)

Abbott

Alinity i Processing Module 
Model: 03R65-01 
S/N: Ai01001 to Ai01336

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
EN-1 

Vk_20180919_03

27.09.2018

Siemens AG Medizinische Technik – AX

ARTIS pheno systems 
S/N: ARTIS pheno-Systeme

MD: Stationary angiographic x-ray system, digital

DE-1 

Vk_20180925_04

27.09.2018

(Updated27.09.2018)

CooperSurgical Inc.

Colpo-Pneumo Occluder 
Model: CPO-6 
Lot: 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 247609, 247610, & 248112

MD: Laparoscopic access cannula, single-use

DE-2 
FR-1 
IT-1 
EN-1 

Vk_20180924_03

21.09.2018

(Updated27.09.2018)

Teleflex Medical SND BHD

CrystalClear Plus, RUSCH CARE CrystalClear (PVC) Tracheostomy Cannula (no Cuff) – Set, RUSCH CrystalClear (PVC) Tracheostomy Cannula (Cuffed / no Cuff) 
Lot: see FSN

MD: Basic tracheostomy tube, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180921_08

26.09.2018

Inpeco S.A.

Aptio Automation 
Model: SMN 11266636

IVD: Specimen processing instrument IVD, automated

DE-1 
FR-1 
EN-1 

Vk_20180924_09

25.09.2018

(Updated26.09.2018)

Medtronic Navigation Inc.

O-arm 1000 Surgical Imaging System (2nd edition) 
Model: BI70000027, BI70000027R, BI70000027100, BI70000027100R, BI70000027120, BI70000027120R, BI70000027230, BI70000027230R, BI70000027GER, BI70000027GERR 
S/N: All (2nd edition)

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180920_12

18.09.2018

(Updated26.09.2018)

Cardiac Pacemaker Inc

ACCOLADE 
Model: L300, L301, L321 
Lot: 1181464200 and 1183081500

ESSENTIO MRI 
Model: L110, L111, L131 
Lot: 1181464200 and 1183081500

VISIONIST X4 
Model: U228 
Lot: 1181464200 and 1183081500

VALITUDE X4 
Model: U128 
Lot: 1181464200 and 1183081500

ACCOLADE MRI 
Model: L310, L311, L331 
Lot: 1181464200 and 1183081500

PROPONENT 
Model: L200, L221 
Lot: 1181464200 and 1183081500

PROPONENT MRI 
Model: L210, L211, L231 
Lot: 1181464200 and 1183081500

ESSENTIO 
Model: L100, L101, L121 
Lot: 1181464200 and 1183081500

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Cardiac resynchronization therapy implantable pacemaker

AIMD: Cardiac resynchronization therapy implantable pacemaker

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

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

Vk_20180911_13

25.09.2018

Beckman Coulter, Inc.

Kaluza C Software 
Model: C10574, C10575, C10576, C10577, C10578, C10579, C10580, C10581, C21166 
SW-Version: v1.0

IVD: Laboratory instrument/analyser application software IVD

DE-1 
EN-1 

Vk_20180921_10

25.09.2018

Carl Zeiss Microscopy GmbH

Cell Observer SD / Laser TIRF / DirectFRAP 
S/N: LM-3834001372

IVD: Microscope, scanning laser optical

EN-1 

Vk_20180919_16

25.09.2018

Endologix International Holdings B.V.

AFX EndoVascular AAA System 
Model: All Models

MD: Abdominal aorta endovascular stent-graft

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180919_10

25.09.2018

Bayer Medical Care Inc.

Low Volume IV Filter 
Model: BC 693 
Lot: See FSN

MD: filters used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems

DE-1 
FR-1 
EN-1 

Vk_20180919_01

25.09.2018

Siemens Healthcare Diagnostics Inc.

Dimension Lipase

IVD: Lipase IVD, kit, enzyme spectrophotometry

DE-1 
FR-1 

Vk_20180918_10

25.09.2018

Data Innovations LLC

Instrument Manager Software

IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE

DE-1 
EN-1 

Vk_20180918_08

20.09.2018

(Updated24.09.2018)

GE Medical Systems Israel, Functional Imaging

Millennium MG, Millennium MC, Millennium MYOSIG

MD: Stationary gamma camera system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180919_23

28.08.2018

(Updated24.09.2018)

Inpeco S.A.

Aptio Automation

IVD: Specimen processing instrument IVD, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180828_09

28.08.2018

(Updated24.09.2018)

Inpeco S.A.

ACCELERATOR a3600

IVD: Specimen processing instrument IVD, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180828_08

28.08.2018

(Updated24.09.2018)

Inpeco S.A.

FlexLab

IVD: Specimen processing instrument IVD, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180828_03

21.09.2018

Axis-Shield Diagnostics Limited

Alere NT-proBNP for ARCHITECT Controls 
Model: 2R10-10 
Lot: 902917627, 902918346

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

DE-1 
FR-1 

Vk_20180914_11

29.08.2018

(Updated21.09.2018)

Hitachi High Technologies Corporation (HHT)

cobas e 411 
Model: see FSN 
S/N: n.a. 
SW-Version: all

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
FR-1 
EN-1 

Vk_20180827_02

28.08.2018

(Updated21.09.2018)

Sysmex Corporation

Automated Hematology Analyzer XN series 
Model: XN-10; XN-20 
S/N: All

IVD: Haematology analyser

FR-2 
EN-2 

Vk_20180824_02

04.09.2018

(Updated20.09.2018)

HeartWare Inc.

HeartWare Ventricular Assist System 
Model: 1407, 1420 
S/N: CON300175 – CON320540

AIMD: Implantable ventricular circulatory assist system

DE-1 
EN-1 

Vk_20180831_02

19.09.2018

Varian Medical Systems Inc.

TrueBeam 
Model: H19 
SW-Version: TrueBeam versions 2.0-2.5

TrueBeam STx 
Model: H19 
SW-Version: TrueBeam versions 2.0-2.5

VitalBeam 
Model: H19 
SW-Version: TrueBeam versions 2.0-2.5

EDGE 
Model: H19 
SW-Version: TrueBeam versions 2.0-2.5

MD: Linear accelerator system

MD: Linear accelerator system

MD: Linear accelerator system

MD: Linear accelerator system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180914_13

19.09.2018

Dispomedica

Embolectomy Catheters 
Model: 09.300W, 09.299V, 09.239T 
Lot: 50031328, 50031633, 50031354

MD: Catheters, Vascular, Embolectomy/Thrombectomy

DE-1 
EN-1 

Vk_20180914_07

19.09.2018

BIOLABO

CHOLESTEROL-HDL Direct Method 200-250 TESTS 
Model: 90206 
Lot: 011601B/011715 A, B; 01171SB/021701N021702N031608N0316 08B/031817B/041627N041627B/041627C/051629B/061723NO 61723B/091744C/101603N101606B/121726A

CHOLESTEROL-HDL Direct Method 400-500 TESTS 
Model: 90406 
Lot: 011624N021702B/031608C/031817N041713N051629C/0618 11N081728B/091613N091744A/091744B/101603B/101606N 111718N121726B

CHOLESTEROL-LDL Direct Method 100 – 125 TESTS 
Model: 90416 
Lot: 031816B/041628N041628B/041713B/041713C/041714B/0817 28N081729A/081729B/121727A

CHOLESTEROL-HDL Direct Method 2000-2500 TESTS 
Model: 90426 
Lot: 051629A

CHOLESTEROL-LDL Direct Method 200 – 250 TESTS 
Model: 90816 
Lot: 31816N041714A/111718B/121727B

HDL LDL CK-MB CALIBRATOR 
Model: 95506 
Lot: 0011624N021702B/031608C/031817N041713N051629C/0618 11N081728B/091613N091744A/091744B/101603B/101606N 111718N121726B

HDL LDL CK-MB Lipids Level 1 Control Serum 
Model: 95516 
Lot: 011602 A, B, C; 121614 A, B, C, D

HDL LDL CK-MB Lipids Level 2 Control Serum 
Model: 95526 
Lot: 121615 A, b, C; 031601 A, B

IVD:

IVD:

IVD:

IVD:

IVD:

IVD:

IVD:

IVD:

FR-1.0 
EN-1.0 

Vk_20180905_21

18.09.2018

Siemens Healthcare Diagnostics Inc.

ADVIA Chemistry Creatine Kinase Assay 
Model: N/A;10729780 
Lot: 433549, 439212 
S/N: N/A 
SW-Version: N/A

IVD: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

DE-1.0 
EN-1.0 

Vk_20180917_08

18.09.2018

Alere Toxicology Plc

Alere DDS2 Test Kit 
Model: N/A;DDS2-403; DDS2-404; DDS2-407; DDS2-412 
Lot: Not lot number specific. All lots within expiry date. 
S/N: N/A

: Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180913_11

18.09.2018

Cardiac Pacemaker Inc

LATITUDE Programmer 
Model: 3300 
S/N: All serial numbers

AIMD: Cardiac pulse generator programmer

DE-1 
FR-1 
EN-1 

Vk_20180911_14

11.09.2018

(Updated17.09.2018)

Greggersen Gasetechnik GmbH

Vakuumregler Pirol 
Model: 904604; 904605; 904606; 904607; 904609; 904620 
S/N: see FSN

MD: Regulator, suction

DE-1 
FR-1 
IT-1 

Vk_20180907_02

17.09.2018

icotec ag

Cannulated tap, 5.5 mm 
Model: REF 42-621 
Lot: 15/01; 15/02

MD: Bone tap, reusable

DE-1.0 
EN-1.0 

Vk_20180906_09

17.09.2018

Therakos Inc.

Cellex Photopheresis System 
SW-Version: All – 3.0, 4.1, 5.1

MD: Photopheresis system

EN-1 

Vk_20180905_09

17.09.2018

Implant Direct Sybron Manufacturing LLC

RePlant Precision IO Scan Adapter 
Model: 6035-09PT, 6043-09PT, 6050-09PT 
Lot: 104539, 104540, 104511

MD: Dental guided surgery reference pin

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180904_09

29.08.2018

(Updated17.09.2018)

Covidien LLC

Covidien EEA Circular Stapler w. Tri-Staple Techn. 
Model: TRIEEAA28MT, TRIEEA28XT, TRIEEA31MT, TRIEEA31XT 
Lot: P8B1538X, P8C1183X, P8D1408X, P8E1213X, P8E1217X, P8B1539X, P8D1405X, P8D1409X, P8E1214X, P8A0976X, P8B1540X, P8D1406X, P8E1211X, P8E1215X, P8A0977X, P8C0032X, P8D1407X, P8E1212X, P8E1216X, P8A0978X, P8C1177X, P8C1178X, P8A0979X, P8B1541X, P8C0033X, P8C11

MD: Intraluminal circular stapler, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180828_05

12.09.2018

RECIPE Chemicals + Instruments GmbH

ClinRep® Complete Kit for Antiepileptics in Serum / Plasma with UHPLC 
Lot: 14100

IVD: Other Other Clinical Chemistry Reagents

EN-1 

Vk_20180910_08

12.09.2018

I2A – Intelligence Artificielle Applications SA

SIRscan discs Amoxicillin 2 ¿g + clavulanic acid 1 ¿g 
Model: 061148 – 065148 
Lot: 170302E, 170317D and 171106D

IVD: IVD Test Reagent/Kits, Cytology/Histology, Decalcifying, Light Microscopy

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180905_19

12.09.2018

Sysmex Corporation

Automated Hematology Analyser XN-Series 
SW-Version: 00-18

IVD: Haematology analyser

EN-1 

Vk_20180905_18

11.09.2018

Hitachi High Technologies Corporation (HHT)

cobas e 411 
Model: GMMI 04775279001, GMMI 04775201001

IVD: Chemiluminescent immunoassay analyser IVD, automated

EN-1 

Vk_20180911_02

11.09.2018

(Updated11.09.2018)

Cordis Corporation

POWERFLEX PRO PTA Dilatation Catheter 
Model: N/A;4400322X, 4400602S, 4400515X, 4400308S, 4400508S 
Lot: 82144115, 82144141, 82144947, 82148810, 82148811 
S/N: N/A 
SW-Version: N/A

MD: Peripheral angioplasty balloon catheter, basic

DE-1 
FR-1 
EN-1 

Vk_20180910_12

11.09.2018

Arthrex INC

DrillSaw Sports 400 System Li-Ion Battery Housing 
Model: AR-400UBH 
Lot: GB4091590, GB4103994, GB4211089, GB4260648, GB4241346, GB4279490, GB4320568, GBP3854432, GBP3854435, GBP3854434

MD: Surgical power tool system handpiece, sawing, rechargeable battery-powered

DE-1 
FR-1 

Vk_20180907_09

11.09.2018

Thoratec Switzerland GmbH

CentriMag Motor 
Model: 201-10002 
S/N: All

MD: Cardiopulmonary bypass system centrifugal pump drive unit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180906_01

11.09.2018

Beckman Coulter, Inc.

Lipase 
Model: OSR6x30 
Lot: all

Uric Acid 
Model: OSR6x98 
Lot: all

IVD: Lipase IVD, kit, enzyme spectrophotometry

IVD: Uric acid IVD, kit, enzyme spectrophotometry

DE-1 
FR-1 

Vk_20180905_24

11.09.2018

Alere San Diego, Inc

Alere Triage NT-proBNP Test 
Model: 98700EU;98700EU 
Lot: K62569B K62570B K62571B K62572B K63039B K63051B K63052B K63137B K63138B K63139B K63140B K63176B K63177B K63178B K63179B K63180B K63182B K63183B K63184B K63185B K63763B K63773B K63774B K63775B

IVD: BNP / proBNP (including other Natriuric Peptides)

DE-1.0 
FR-1.0 
IT-1.0 
EN-1 

Vk_20180903_15

10.09.2018

Ovesco Endoscopy

AWC-Additional Working Channel 
Model: 200.57.01, 200.57.04 
Lot: 200.57.01: 808916, 809381; 200.57.04: 808917, 809382

MD: Endoscope channel support kit

DE-1 

Vk_20180903_14

03.09.2018

(Updated10.09.2018)

Roche Diagnostics GmbH

cobas h 232 
Model: See FSN

CoaguChek XS 
Model: See FSN

CoaguChek XS Pro 
Model: See FSN

CoaguChek XS Plus 
Model: See FSN

CoaguChek Pro II 
Model: See FSN

Accu-Chek Inform II 
Model: See FSN

IVD: Enzyme immunoassay (EIA) analyser IVD, semi-automated

IVD: Coagulation analyser IVD, laboratory, semi-automated

IVD: Coagulation analyser IVD, laboratory, semi-automated

IVD: Coagulation analyser IVD, laboratory, semi-automated

IVD: Coagulation analyser IVD, laboratory, semi-automated

IVD: Glucose analyser IVD, point-of-care

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180828_01

09.09.2018

B. Braun Melsungen AG

INTRAFIX SAFESET LL 
Model: 40063000

MD: Electric infusion pump administration set, single-use

DE-1 
FR-1 
IT-1 

Vk_20180903_05

29.08.2018

(Updated09.09.2018)

Degania Silicone Ltd.

Mon-a-Therm Foley catheters with temperature sensors 
Model: see FSN 
Lot: see FSN

MD: Temperature-monitoring indwelling urethral drainage catheter

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180827_07

07.09.2018

Haemonetics S.A.

Plasma collection HS bowl 
Model: 782HS-P-SL; 782HS-P-SL 
Lot: 9217036

MD: Apheresis system tubing set

FR-1 

Vk_20180831_18

20.07.2018

(Updated07.09.2018)

ConvaTec Limited

Suction Catheters 
Model: See both FSN 
Lot: All lots manufactured between 2013-07-01 and 2018-06-30

Intermittent Urology Catheters 
Model: See both FSN 
Lot: All lots manufactured between 2013-07-01 and 2018-06-30

Sterile Urine Drainage Bags 
Model: See both FSN 
Lot: All lots manufactured between 2013-07-01 and 2018-06-30

Gastro-enteral Tubes 
Model: See both FSN 
Lot: All lots manufactured between 2013-07-01 and 2018-06-30

MD: Tracheal suction catheter

MD: Single-administration urethral drainage catheter

MD: Open-ended non-wearable urine collection bag, sterile

MD: Duodenal Tubes, Stomach Tubes and Feeding Tubes

DE-1 
DE-2 – weitere Produkte 
FR-1 
FR-2 – autres produits 
IT-1 
IT-2 – ult. prodotti 
EN-1 
EN-2 – add. Products

Vk_20180709_08

04.09.2018

BioFire Diagnostics, LLC

FilmArray Blood Culture Identification Panel-BCID 
Model: RFIT-ASY-0127 / RFIT-ASY-0126;RFIT-ASY-0127 / RFIT-ASY-0126 
Lot: All manufactured batches

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

DE-1 
FR-1 
EN-1 

Vk_20180903_11

11.07.2018

(Updated04.09.2018)

SEDECAL S.A.

Nova

MD: X-ray system tube support, ceiling mount

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180709_02

04.09.2018

Siemens Healthcare Diagnostics Inc.

Syva Emit II Plus 6-Acetylmorphine assay 
Model: 9R039UL, 9R129UL

IVD: Unclassified

EN-1 

Vk_20180326_03

03.09.2018

Alcon Laboratories, Inc.

CyPass Micro-Stent 
Model: 241, 261

MD: Glaucoma shunt

DE-1 
FR-1 

Vk_20180829_16

31.08.2018

Biocartis NV

Idylla Instrument 
Model: P0010 
S/N: 00001764, 00001767, 00001769, 00001770 
SW-Version: ISW/25.0, ISW/26.0

: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

FR-1 
EN-1 

Vk_20180821_04

20.08.2018

(Updated31.08.2018)

Vision RT Limited

AlignRT 
Model: PCB Part Number V000172 
SW-Version: IGC TB PCB firmware version 1171

MD: Video camera patient positioning/tracking system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180813_12

28.08.2018

(Updated30.08.2018)

William Cook Europe ApS

Zenith Alpha Thoracic Endovascular Graft 
Model: All ZTA-devices (see FSN)

MD: Synthetic vascular graft

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180821_07

30.08.2018

MEDOS Medizintechnik AG

s.pump 
Model: ME SP02 0001 
Lot: see attached FSN

MD: Cardiopulmonary bypass system centrifugal pump

DE-1 

Vk_20180821_05

21.08.2018

(Updated30.08.2018)

Oridion Medical 1987 Ltd.

Capnostream 20 and Capnostream 20p Bedside Patient Monitors 
Model: see FSN 
S/N: all

MD: Carbon dioxide monitor

DE-1 
EN-1 

Vk_20180816_08

30.08.2018

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

Ysio 
Model: 10281013, 10281163

Ysio Max 
Model: 10762470

MD: Stationary basic diagnostic x-ray system, digital

MD: Stationary basic diagnostic x-ray system, digital

DE-1 
FR-1 

Vk_20180814_06

30.08.2018

BD Switzerland Sàrl

Alaris / Asena CC, GH Syringe Pump 
Model: 8002TIG01, 8002TIG01-G, 8003TIG01, 8003TIG01-G;N/A 
S/N: Multiple

MD: Syringe pump

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180803_17

29.08.2018

Maquet Critical Care AB

Servo-n 
Model: 6688600; 66888011 
S/N: 1682, 1683, 1617,1618,1619, 1632,1633, 1283, 1284, 1285, 1029 
SW-Version: 3.00.00

MD: Neonatal/adult intensive-care ventilator

EN-1 

Vk_20180828_02

27.08.2018

(Updated29.08.2018)

Leica Microsystems (Schweiz) AG

Leica M525 F20 
S/N: All

MD: General-purpose surgical microscope

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180820_04

28.08.2018

Siemens Healthcare Diagnostics Inc.

Aptio Automation System/StreamLAB Analytical Workcell 
Model: see FSN

IVD: Specimen processing instrument IVD, automated

DE-1 
FR-1 
EN-1 

Vk_20180827_05

28.08.2018

Siemens Medical Solutions USA, Inc.

Biograph mCT systems, Biograph mCT Flow systems 
Model: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10250743, 10250745, 10507786, 10528955, 10529159

MD: Stationary gamma camera system

DE-1 
FR-1 
IT-1 

Vk_20180824_01

28.08.2018

Roche Diagnostics GmbH

CoaguChek PT Test 
Model: Please refer to product list in Attachment 1. 
Lot: Please refer to product list in Attachment 1.

IVD: Prothrombin time (PT) IVD, kit, clotting, rapid

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180822_14

28.08.2018

MetaSystems Probes GmbH

XL t(3;3) GATA2/MECOM DF 
Model: D-5124-100-OG 
Lot: Lot 20191

IVD: Acquired genetic alteration IVDs

EN-1 

Vk_20180822_12

28.08.2018

Valtech Cardio Ltd.

Cardioband Mitral Reconstruction System 
Model: VSU04001 
Lot: S200914, S201347, S201348, S201511, S201543, S201544, S201645, S201647, S201748, S201958, S202944, S202947, S202948

MD: Mitral annuloplasty ring

DE-1 
EN-1 

Vk_20180821_03

27.08.2018

ACUTRONIC Medical Systems AG

fabian Therapy evolution 
Model: 121001

MD: Neonatal intensive-care ventilator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180816_02

27.08.2018

CIVCO Medical Instruments CO

Endocavity Needle Guide 
Model: 676-144, 676-150 
Lot: see FSN

MD: Nonimplantable needle guide, single-use

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180816_01

27.08.2018

Peek Vision Ltd

Peek Acuity Pro App 
Model: PV_PAC_001 
SW-Version: 3.5.2

MD: Dynamic visual acuity testing system

EN-1 

Vk_20180814_21

15.08.2018

(Updated27.08.2018)

BioGX BV

BioGX 
Model: 400-002-C-MAX 
Lot: 409-17-002XA; 349-17-002XA; 455-17-002XA

IVD: Unclassified

FR-1 
EN-1 

Vk_20180814_01

14.08.2018

(Updated27.08.2018)

Ventana Medical Systems Inc

FLO-LOK III Dispenser 
Model: See FSN 
Lot: See FSN

IVD: Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

DE-1 
FR-1 
EN-1 
EN-2 

Vk_20180809_03

14.08.2018

(Updated27.08.2018)

Medica, Medizintechnik GmbH

THERA-Trainer balo / THERA-Trainer verto 
S/N: A002-308-02-13212014 bis A002-308-02-18044701 und A002-678-00-13274045 bis A002-678-01-18025385

MD: Exerciser

DE-1 
FR-1 
EN-1 

Vk_20180807_04

14.08.2018

(Updated27.08.2018)

Esaote S.p.a.

MyLab 
Model: Alpha, Six, Six Crystaline, Seven, Gamma

MD: General-purpose ultrasound imaging system

DE-1 
FR-1 
EN-1 

Vk_20180802_21

27.08.2018

Intuitive Surgical, Inc

da Vinci EndoWrist Monopolar Curved Scissors 
Model: 420179-16; 470179-14 
Lot: Manufacturing date 2015-09-2015 to 2018-02-22, Distribution date 2016-02-22 to 2018-05-29

MD: Robotic electrosurgical instrument, monopolar, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180731_01

22.08.2018

(Updated23.08.2018)

BioMérieux Inc.

AST-P640 Test Kit and AST-P655 Test Kit 
Model: 418579 (AST-P640 Test Kit) / 421913 (AST-P655 Test Kit)
Lot: see FSN

IVD: General-microorganism antimicrobial susceptibility culture medium IVD

DE-1 
FR-1 
EN-1 

Vk_20180816_13

22.08.2018

(Updated23.08.2018)

Siemens Healthcare Diagnostics Inc.

Hematek Wright-Giemsa Stain Pak 
Model: 01178588, SMN 10314755 
Lot: See FSN 
S/N: N/A

Hematek Modified Wright Stain Pak 
Model: 06689653, SMN 10310965 
Lot: See FSN 
S/N: N/A

IVD: Wright-Giemsa staining solution IVD

IVD: Wright staining solution IVD

DE-1 
FR-1 
EN-1 

Vk_20180814_16

22.08.2018

(Updated23.08.2018)

Siemens Healthcare GmbH

Artis Q

ARTIS pheno systems

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

DE-1 
FR-1 
EN-1 

Vk_20180814_08

22.08.2018

Chalybs Medical Devices GmbH

Knopfkanüle gebogen 
Model: SUCH14651 
Lot: CH2014-101226

MD: Cannula

DE-1 

Vk_20180822_15

22.08.2018

Ortho Clinical Diagnostics Inc.

VITROS 5600 
Model: 6802413; 6802915 
S/N: All VITROS 5600 systems currently on the marketplace 
SW-Version: 3.3.1 and below

IVD: Clinical chemistry analyser

DE-1 
EN-1 

Vk_20180817_01

21.08.2018

Dr. Mach GmbH & Co. GmbH

Lighting systems consisting of flange tubes and lights from Dr. Mach and the associated suspension system (heavy central axis, extension arm and spring arm) from the suspension system manufacturer.

MD: Operating shadowless light

DE-1 
FR-1 
EN-1 

Vk_20180807_02

15.08.2018

(Updated20.08.2018)

Philips Medical Systems Nederland BV

Allura Xper and Integris 
Model: Allura Xper and INTEGRIS systems (see FSN) 
Lot: NA 
SW-Version: NA

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180813_01

20.08.2018

Frei AG – Aktive Rehasysteme

Gym Treatment Table 
Model: See FSN 
S/N: All constructions before 2009

Gym X Treatment Table 
Model: See FSN 
S/N: All constructions before 2009

MD: Physical therapy table, non-powered

MD: Tables, Examination/Treatment, Adjustable, Physical Therapy

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180809_07

20.08.2018

Infomed SA

Plasmafractionator Medopen

MD:

FR-1.0 

Vk_20180809_05

20.08.2018

Medtronic MiniMed

MiniMed remote controller 
Model: MMT-500, MMT-503 
S/N: All

MD: Basic remote control

DE-1 
FR-1 
EN-1 

Vk_20180808_11

15.08.2018

Agfa Healthcare

DX-D 600

MD: Stationary basic diagnostic x-ray system, digital

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180809_06

14.08.2018

SOMATEX Medical Technologies GmbH

Transplant-Aspiration Needle 
Model: 180635 
Lot: see FSN

Biopsy Cannula SPI-CUT 
Model: 180820, 180830, 180840, 180845, 180850, 180860, 180870 
Lot: see FSN

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

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

DE-1 
EN-1 

Vk_20180810_03

14.08.2018

Medcomp

Double Lumen Catheter Set

MD: Double-lumen haemodialysis catheter, nonimplantable

DE-1 
FR-1 
IT-1 

Vk_20180719_01

13.08.2018

Datex Ohmeda; GE Medical Systems (China) Co., Ltd

Carestation 620, Carestation 650, Carestation 650c

Carestation 30, 9100c NXT

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180808_01

13.08.2018

Beckman Coulter, Inc.

UniCel DxH 600 Coulter Cellular Analysis System 
Model: see FSN 
S/N: All 
SW-Version: 1.3.0 and below

UniCel DxH 800 Coulter Cellular Analysis System 
Model: see FSN 
S/N: All 
SW-Version: 3.2.0 and below

IVD: Haematological cell analyser IVD, automated

IVD: Haematological cell analyser IVD, automated

DE-1 
FR-1 
EN-1 

Vk_20180802_25

08.08.2018

(Updated13.08.2018)

Philips Medical Systems

Philips SureSigns VS & VM Monitors, and View Station (VSV)

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180802_23

26.07.2018

(Updated13.08.2018)

AURUM HEALTHCARE

Aurum Healthcare Tubing Systems 
Model: 22-1042-00, 22-1042-01, 22-1042-02, 22-1042-08, 22-1042-11, 22-1042-18. 22-1042-21, 22-1042-25 
Lot: See FSN

MD: Non active devices for anesthesia, emergency and intensive care; non active devices for injection, infusion, transfusion and dialysis

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180717_12

03.07.2018

(Updated13.08.2018)

RaySearch Laboratories AB

RayStation 
Model: RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) 
SW-Version: build number: 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.3, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 7.0.0.19, 8.0.0.61

MD: Radiation therapy software

DE-2 
FR-2 
IT-2 
EN-1 
EN-2 

Vk_20180702_18

10.08.2018

Smiths Medical MD, Inc.

Gripper Plus needle 
Model: see FSN 
Lot: see FSN

PORT-A-CATH Plastic Hub Bent Needle 
Model: see FSN 
Lot: see FSN

MD: Subcutaneous injection/infusion port needle

MD: Subcutaneous injection/infusion port needle

DE-1 
EN-1 

Vk_20180806_07

09.08.2018

(Updated09.08.2018)

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur CKMB Calibrator 
Model: 09318028 
Lot: 57834A64, 57835A64, 72519A64, 98115A64

Atellica IM CKMB Calibrator 
Model: 10995532 
Lot: 57837A66, 67443A66

ADVIA Centaur CKMB MCM 
Model: 07867768 
Lot: 35061

Atellica IM CKMB MCM 
Model: 10995534 
Lot: 11803

IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, control

IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, control

DE-Atellica 1 
DE-Centaur 1 
EN-Atellica 1 
EN-Centaur 1 

Vk_20180802_12

08.08.2018

(Updated09.08.2018)

EOS imaging

sterEOS image review workstation 
SW-Version: all

MD: Radiology DICOM image processing application software

DE-1 
FR-1 
EN-1 

Vk_20180802_03

02.08.2018

(Updated09.08.2018)

Idoman Teoranta

Thermablate EAS 
Model: 22101, 21004

MD: Endometrial-ablation hyperthermia control unit

DE-1 
FR-1 
EN-1 

Vk_20180725_12

15.05.2018

(Updated09.08.2018)

Roche Diagnostics GmbH

cobas m 511 integrated hematology analyzer 
Model: 07261691190 
SW-Version: 1.0

IVD: Cell morphology analyser IVD, automated

DE-1 
EN-1 
EN-2 

Vk_20180509_02

08.08.2018

Bausch & Lomb Inc.

Stellaris Elite Single Port Vitrectomy Cutters 
Model: Gauge sizes 20, 23, 25 
Lot: See FSN

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

DE-1 
FR-1 
IT-1 

Vk_20180806_06

07.08.2018

Covidien LLC

BIS Vista and BIS View Monitoring Systems 
Model: 186-1046, 186-1049, 186-1002-RFB, 186-1001-RFB, 186-0215, 185-0151, 186-1015,186-1048 
Lot: All

MD: Anaesthesia depth monitor

DE-1 
FR-1 
IT-1 

Vk_20180806_09

07.08.2018

Biomet Orthopaedics, LLC

Affixus Hip Fracture Nail 
Model: see fsn 
Lot: Various see FSN

MD: Femur nail, sterile

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180802_24

07.08.2018

Weinmann Emergency Medical Technology GmbH + Co.KG

MEDUMAT Transport Akkupack or Akkupack Plus 
Model: WM 28300, WM 28400, WM 28384, WM 28385

MD: Transport electric ventilator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180724_07

03.08.2018

Reckitt Benckiser Healthcare (UK) Limited

Durex Natural Feeling, Natural Feeling Easy Glide and Love Collection 
Model: see FSN 
Lot: see FSN

MD: Basic male condom, synthetic polymer

DE-Grosshandelsrückruf
DE-Rückruf Endkunde 
FR-Rappel consommateur 
FR-Rappel en gros 
IT-Richiamo consumatore 
IT-Richiamo ingrosso

Vk_20180726_08

02.08.2018

(Updated03.08.2018)

Abbott

ARCHITECT EBV VCA IgM 
Model: 3P66-25, 3P66-35 
Lot: 85278LI00, 85279LI00

IVD: Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180725_08

31.07.2018

(Updated02.08.2018)

MAQUET Cardiopulmonary GmbH

HCU40 
Model: 70104.4054 
S/N: S/N 90440387 to 90440728; S/N 90440366 
SW-Version: 1.2.3.0

MD: Cardiopulmonary bypass system heat exchanger

DE-1 
DE-2 
EN-1 
EN-2 

Vk_20180731_02

31.07.2018

(Updated02.08.2018)

Integra LifeSciences Corporation

Knob Assembly contained in MAYFIELD 
Model: A2079, A2079A, A2079E, A2600R; S437A2409, 437A2409

MD: Knob assembly of the MAYFIELD Infinity XR2 Swivel Adapter (Skull Clamp)

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180725_01

02.08.2018

Siemens Healthcare Diagnostics Inc.

RAPIDPoint 405/500 Systems 
Model: 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 / 10492730, 10696855, 10696857, 10697306 
S/N: All serial numbers

RAPIDLab 1245/1265 Systems 
Model: 10321844, 10337179, 10491393 / 10321852, 10470366, 10491395 
S/N: All serial numbers

IVD: Blood gas/pH/electrolyte/metabolite analyser

IVD: Blood gas/pH/electrolyte/metabolite analyser

DE-1 
FR-1 
EN-1 

Vk_20180724_08

23.07.2018

(Updated02.08.2018)

Servona GmbH

Servona Silberkanüle 
Model: Diverse Modelle (siehe FSN)

MD: Cannula, Tracheostomy, Reusable

DE-1 
FR-1 
IT-1 

Vk_20180713_06

02.08.2018

Dako North America, Inc.

Monoclonal Mouse Anti-Human MSH2 FE11 
Model: M3639

IVD: Streptococcus A rapid test device

FR-1 
EN-1 

Vk_20180628_07

02.07.2018

(Updated02.08.2018)

Frei AG – Aktive Rehasysteme

Arcus – treatment table 
Model: Standard: 8.5100.00, 8.5100.50, 8.5100.50a; Universal: 8.5105.00, 8.5105.50, 8.5105.50a; Manual: 8.5110.00, 8.5110.50, 8.5110.50a; Vojta 120cm wide: 8.5115.00, 8.5115.50, 8.5115.50a; Vojta 100cm wide: 8.5116.00, 8.5116.50, 8.5116.50a
S/N: All constructions before 2009

MD: Tables, Examination/Treatment, Adjustable, Physical Therapy

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180622_06

31.07.2018

The Binding Site Group Limited

Human IgM Kit for use on SPAPLUS 
Model: NK012.S 
Lot: 407483

IVD: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

DE-1 
EN-1 

Vk_20180727_03

31.07.2018

Qiagen GmbH

EZ1 Advanced XL 
Lot: 9001492 
S/N: There are 293 instruments in the field ranging from serial numbers L166A1801 to L185A2137

IVD: Other Other Genetic Tests

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180725_02

24.07.2018

(Updated31.07.2018)

EDAP TMS FRANCE

Sonolith i-move 
Model: TMS 232551 
S/N: 011 to 203 included 
SW-Version: 2.13

MD: Lithotripsy system, external

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180723_01

25.07.2018

(Updated31.07.2018)

Diagnostica Stago

STA Néoplastine CI 10 and CI Plus 10 
Model: 00666 ; 00667 
Lot: see FSN

IVD: Prothrombin time kit

DE-1 
FR-1 
EN-1 

Vk_20180720_14

25.07.2018

(Updated31.07.2018)

Mikrogen GmbH

recomWell Borrelia IgM 
Model: 4205 
Lot: EBB081702 / EBB081703

IVD: Lyme Antibody IgM

DE-1 
EN-1 

Vk_20180718_01

25.04.2018

(Updated31.07.2018)

Roche Diagnostics GmbH

Vitamin D total II, Elecsys Vitamin D total II 
Model: 07464215190, 07028148190 
Lot: n.a.

IVD: 25-Hydroxy vitamin D3 IVD, reagent

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

Vk_20180418_01

25.07.2018

(Updated30.07.2018)

Cepheid AB

Xpert C.Difficile BT 
Model: GXCDIFFBT-CE-10 
Lot: 1000094830

IVD: Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180723_09

24.07.2018

(Updated30.07.2018)

Ortho Clinical Diagnostics

VITROS Immunodiagnostic Products Folate Reagent Pack 
Model: 1513266 
Lot: Applicable to all expired, in-date and future lots.

VITROS Immunodiagnostic Products Free PSA Reagent Pack 
Model: 6842845 
Lot: Applicable to all expired, in-date and future lots.

VITROS Immunodiagnostic Products FSH Reagent Pack 
Model: 1931922 
Lot: Applicable to all expired, in-date and future lots.

VITROS Immunodiagnostic Products Prolactin Reagent Pack 
Model: 1849793 
Lot: Applicable to all expired, in-date and future lots.

VITROS Immunodiagnostic Products TSH Reagent Pack 
Model: 1912997 
Lot: Applicable to all expired, in-date and future lots.

IVD: Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

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

IVD: Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

IVD: Prolactin IVD, kit, chemiluminescent immunoassay

IVD: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

DE-1 
EN-1 

Vk_20180723_08

25.07.2018

(Updated30.07.2018)

Abbott

Alinity c Creatine Kinase 
Model: 08P4220 
Lot: 99634UN18 
S/N: N/A

IVD: Total creatine kinase (CK) IVD, reagent

DE-1 
EN-1 

Vk_20180720_03

25.07.2018

(Updated30.07.2018)

Abbott Laboratories

ARCHITECT Creatine Kinase 
Model: 7D63-21; 7D63-41 
Lot: 87697UN18; 99632UN18; 24358UN18; 99633UN18

IVD: Total creatine kinase (CK) IVD, reagent

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180720_02

25.07.2018

(Updated30.07.2018)

Abbott Laboratories

ARCHITECT c4000 / c8000 / c16000 Processing Module 
Model: 02P24; 01G06; 03L77 
S/N: All Serial numbers 
SW-Version: ARCHITECT Software v8.10, v9.00, v9.10, v9.20, v9.25

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180718_12

30.07.2018

B. Braun Melsungen AG

Perifix Catheter Connector 
Lot: see FSN

MD: Luer adaptor

DE-1 
FR-1 
IT-1 

Vk_20180716_11

26.07.2018

(Updated27.07.2018)

Regen Lab SA

ArthroVisc40 
Model: ARV-HA40-1 
Lot: See FSN

Cellular Matrix 
Model: BCT-HA-1, BCT-HA-3T, A-CP-HA-1, A-CP-HA-3T 
Lot: See FSN

SkinVisc40 
Model: SKV-HA40-1 
Lot: See FSN

MD: Synovial fluid supplementation medium

MD: Haematological concentrate system kit, platelet concentration

MD: Dermal tissue reconstructive material, microbe-derived

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180716_04

26.06.2018

(Updated27.07.2018)

Stryker Trauma Kiel

T2 Ankle Arthrodesis Nail, left 
Model: 18181115S 
Lot: See FSN

T2 Ankle Arthrodesis Nail, right 
Model: 18191020S, 18191220S 
Lot: See FSN

T2 Proximal Humeral Nail, left 
Model: 18322824S, 18322828S 
Lot: See FSN

T2 Proximal Humeral Nail, right 
Model: 18321045S, 18323826S 
Lot: See FSN

MD: Arthrodesis nail, sterile

MD: Arthrodesis nail, sterile

MD: Humerus nail, sterile

MD: Humerus nail, sterile

DE-1 
EN-1 

Vk_20180618_02

05.12.2016

(Updated27.07.2018)

Siemens Healthcare Diagnostics Products Limited

IMMULITE 1000 PSA 
Model: LKPS1, LKPS5; SMN 10380960, 10380949 
Lot: all

IMMULITE 2000 Xpi PSA 
Model: L2KPS2, L2KPS6; SMN 10380986, 10380996 
Lot: all

IMMULITE PSA 
Model: LKPS1, LKPS5; SMN 10380960, 10380949 
Lot: all

IMMULITE 2000 PSA 
Model: L2KPS2, L2KPS6; SMN 10380986, 10380996 
Lot: all

IVD: Prostate specific antigen kit

IVD: Total prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay

IVD: Prostate specific antigen kit

IVD: Total prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay

DE-2 
FR-2 
EN-2 

Vk_20161128_12

20.07.2018

(Updated26.07.2018)

Medtronic Inc.

Vectris Lead Kits 
Model: See FSN 
Lot: Specific lots with an expiration date 31-Oct-2021 through 08-Mar-2022

AIMD: Neural-tissue electrical stimulation lead

FR-1 
EN-1 

Vk_20180716_09

26.07.2018

William A. Cook Australia Pty Ltd

Zenith Branch Endovascular Graft Iliac Bifurcation 
Lot: See FSN 
S/N: See FSN

MD: Synthetic vascular graft

DE-1.0 
FR-1 
IT-1 

Vk_20180226_08

25.07.2018

Steris Corporation

AMSCO V-PRO 1

V-PRO 1 Plus

VPRO maX

MD: Hydrogen peroxide gas sterilizer

MD: Hydrogen peroxide gas sterilizer

MD: Hydrogen peroxide gas sterilizer

EN-1.0 

Vk_20180720_12

25.07.2018

Medline International France SAS

LDH SET, NEURO OPS 
Model: ZGZNE004G 
Lot: 755464, 757690

AUGEN-SET SRRWS 
Model: ZGZEY034C 
Lot: 758036

CRANIOTOMIE SET,NEURO OPS 
Model: HGGNE121 
Lot: 755572

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

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

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

DE-1.0 
EN-1.0 

Vk_20180719_15

25.07.2018

Horiba ABX SAS

Yumizen H2500 & H2500 SPS 
SW-Version: Version 1.1.0 and lower

IVD: Haematology analyser, cell differential

EN-1 

Vk_20180719_12

17.07.2018

(Updated25.07.2018)

Cerus Corporation

INTERCEPT Processing Set for LV Platelet Units 
Model: INT2203B 
Lot: recall: CE17J26L71 inspection: all lot numbers before CE18F02L71

MD: Platelet photochemical treatment kit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180716_16

19.06.2018

(Updated25.07.2018)

RaySearch Laboratories AB

RayStation 
Model: 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9 (RayPlan 1), 5, 6 (RayPlan 2), 7 (RayPlan 7)

MD: Radiation therapy software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180608_06

24.07.2018

Gebr. Gloor AG

SWISS optio terminal unit AGSS 
Model: GM31xx 
Lot: All

MD: Medical Gas Outlets

DE-1 
FR-1 

Vk_20180720_21

24.07.2018

Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis Q/Pheno systems 
Model: Artis Q floor 10848280, Artis Q ceiling 10848281, Artis Q biplane 10848282, Artis zeego 10848283, Artis Q.zen floor 10848353, Artis zeego 10848354, Artis Q.zen biplane 10848355, ARTIS pheno 10849000 
S/N: Artis Q/Pheno systems and X-ray generator

MD: Stationary angiographic x-ray system, digital

DE-1 
FR-1 

Vk_20180719_19

28.06.2018

(Updated23.07.2018)

Radiometer Medical ApS

ABL800 
Model: 393-800, 393-801 
S/N: All 
SW-Version: Software versions 6.14 to 6.18

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180620_03

26.06.2018

(Updated23.07.2018)

Microgenics Corporation

QMS Teicoplanin 
Model: 0374652 (calibrator), 0374645 (reagent) 
Lot: calibrator:73032439, reagent: all

IVD: Teicoplanine kit

DE-1 
EN-1 

Vk_20180619_12

14.11.2017

(Updated23.07.2018)

MULLIEZ FLORY

SECURIDRAP SELFIA 
Model: blanc (reference fabriquant no 013293W02B0); bleu (reference fabriquant no 013293B02B0) 
S/N: all

MD: safety bedding

FR-1 
FR-2 

Vk_20170728_06

17.07.2018

(Updated20.07.2018)

bioMérieux SA

VIDAS CA 15-3 
Model: 30429 
Lot: 1006022590 and 1006251930

IVD: Cancer antigen 15-3 kit

DE-1 
FR-1 
EN-1 

Vk_20180716_06

20.07.2018

DiaMed GmbH

IH-Com Kit Fullversion 
Model: catalogue: 009000 
SW-Version: IH-Com version 5.1

IH-Com Kit For Reader 
Model: catalogue: 009010 
SW-Version: IH-Com version 5.1

IVD: Laboratory instrument/analyser application software IVD

IVD: Laboratory instrument/analyser application software IVD

DE-1 
EN-1 

Vk_20180710_11

19.07.2018

William A. Cook Australia Pty Ltd

Cook Chorionic Villus Biopsy Needle Set 
Lot: All lots manufactured up to 4 June 2018

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180717_05

17.07.2018

(Updated19.07.2018)

BEKA Hospitec GmbH

Alu CARLO 
Model: 925001000, 925002000, 925003000

MD: Mobile patient lifting system, battery-powered

DE-1 
FR-1 
IT-1 

Vk_20180710_02

19.07.2018

Frei AG – Aktive Rehasysteme

Height-adjustable training table 
Model: 6.5550.60; 6.5550.70; 6.5550.71; 6.5550.71a; 6.5550.72 
Lot: Juli 2006

MD: Tables, Examination/Treatment, Adjustable, Physical Therapy

DE-1 
EN-1 

Vk_20180709_09

04.07.2018

(Updated19.07.2018)

Fresenius Medical Care AG & Co. KGaA

5008 CorDiax HD-PAED option 
SW-Version: 3.54, 4.10, 4.11, 4.50, 4.57, 4.58, 4.62

MD: Haemodialysis system, institutional/home-use

DE-1 
FR-1 
EN-1 

Vk_20180702_08

16.07.2018

(Updated19.07.2018)

Frei AG – Aktive Rehasysteme

Thera – treatment table 
Model: See FSN 
S/N: All constructions before 2009

MD: Tables, Examination/Treatment, Adjustable, Physical Therapy

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180627_07

18.07.2018

DiaMed GmbH

Anti-Jka 
Model: 17610; catalogue: 104301 
Lot: 17610 83 01, 17610 82 01 and 17610 81 01

IVD: Anti-Jk^a red blood cell grouping IVD, antibody

DE-1 
EN-1 

Vk_20180711_04

10.07.2018

(Updated18.07.2018)

Medtronic MiniMed

Guardian Connect Application 
Model: CSS7200 
SW-Version: v3.0.1

MD: Patient health record information system application software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180706_12

17.07.2018

Heraeus Medical GmbH

COPAL knee moulds 
Model: 66058096 
Lot: 130011

MD: Orthopaedic cement spacer mould

DE-1 
EN-1 

Vk_20180716_08

17.07.2018

Biomet Orthopaedics

Persona Spacer Block Alignment Tower 
Model: 42-5399-006-35 
Lot: 63465803, 63762260, 63767434, 63799794

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1 
FR-1 
IT-1 

Vk_20180712_08

17.07.2018

Lohmann GmbH & Co KG

Raucodrape camera drape 16×250 in set Kitpack 
Model: 3007995 
Lot: 17155L28, 18111L51, 18141L29

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

DE-1 

Vk_20180712_01

17.07.2018

Philips Medical Systems DMC GmbH

Patient Support 
Model: 989001087431;NA

MD:

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180711_07

17.07.2018

Teleflex Medical

Rusch Green Lite (MAC 3) 
Model: See FSN 
Lot: See FSN

MD: Laryngoscope blade, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180710_09

16.07.2018

Intuitive Surgical, Inc

da Vinci Xi Surgical System 
Model: IS4000 Surgical System 
Lot: IS4000 with software upgrade A70_P8_B622 
S/N: SK0204; SK0232; SK0248 
SW-Version: A70_P8_B622

MD: Robotic surgical system

EN-1 

Vk_20180702_03

12.07.2018

MicroPort CRM S.r.l.

PLATINIUM 
Model: VR 1210, VR 1240, DR 1510, DR 1540, CRT-D 1711, SonR CRT-D 1811, CRT-D 1741, SonR CRT-D 1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844

AIMD: Single-chamber implantable defibrillator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180712_03

12.07.2018

Etac AS, Etac Supply Gjovik

Molift 2-point Sling Bar 
Model: all sizes: 1430016, 1430017, 1430021, 1830001, 183002, 183002C, 1830003

MD: Mobile patient lifting system, battery-powered

EN-1 

Vk_20180706_10

12.07.2018

Draeger Medical Systems, Inc.

Jaundice meter 
Model: JM-103, JM-105 
Lot: All affected devices

MD: Transcutaneous bilirubinometer

DE-1_103 
DE-1_105 
FR-1_103 
FR-1_105 
IT-1_103 
IT-1_105 

Vk_20180413_17

11.07.2018

AIR LIQUIDE MEDICAL SYSTEMS

MONNAL T60 
Model: KA010000

Monnal T60 JP 
Model: KA013700

MD: Neonatal/adult intensive-care ventilator

MD: Transport electric ventilator

DE-1 
FR-1 
EN-1 

Vk_20180710_04

11.07.2018

Gebr. Gloor AG

SWISS optio terminal unit DIN 
Model: GM30xx

MD: Medical gas outlet

DE-1 
FR-1 

Vk_20180710_01

11.07.2018

Haemonetics Corporation

OPAT RESERVOIR 
Model: OPT-R-1000 
Lot: 1117066

ORTHOPAT INTEGRATED SET 
Model: 1150H-00 
Lot: 1017049, 1017050, 1017072

MD: Blood-processing autotransfusion system set

MD: Blood-processing autotransfusion system set

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180709_06

11.07.2018

Siemens Healthcare Diagnostics Inc.

Atellica Solution IM 1300 Analyzer and Atellica Solution IM 1600 Analyzer

IVD: Chemiluminescent immunoassay analyser IVD, automated

EN-1 

Vk_20180706_07

11.07.2018

Cepheid AB

Xpert MTB/RIF Ultra 
Model: GXMTB/RIF-ULTRA-10 
Lot: 1000080188

IVD: MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1 
FR-1 
EN-1 

Vk_20180705_09

11.07.2018

Menarini Silicon Biosystems lnc.

CellSearch Circulating Tumor Cell Kits 
Model: 7900001 
Lot: 5038- S038R- 50385- S038T- S038U- S038V

IVD: Radiation therapy treatment record/verify system

DE-1 
EN-1 

Vk_20180705_03

11.07.2018

OrthoScan Inc

OrthoScan HD 1000OrthoScan Mini C-Arm X-Ray System 
Model: OrthoScan HD 1000 -0004; OrthoScan FD 1000-0004; OrthoScan Mobile DI1000-0005; OrthoScan 1000-0004-FD 
Lot: The Software which is nonconforming was used in production between February 2008 and October 2016 on total 333 devices 
S/N: see FSN

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

DE-1 
FR-1 
IT-1 

Vk_20180704_10

10.07.2018

Philips Medical Systems Nederland BV

Allura Xper, UNIQ and Centron 
Model: 722003, 722005, 722006, 722008, 722014, 722015, 722019, 722020, 722010, 722011, 722012, 722013, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722039, 722059 
SW-Version: See FSN

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180706_03

10.07.2018

Meditrade GmbH

BeeSana Mullkompresse 
Model: 5×5 cm; 8-fach; 1043 
Lot: 7855-1406

MD: Compresses, Gauze

DE-1 

 

 

2018.08.03

Dear Doctor Letter (Rote-Hand-Brief) on ulipristal acetate (Esmya®): restricted indication, new contraindication and requirements for liver monitoring

Active substance Ulipristalacetat

PDF430KB

2018.08.02

Hydroxyethyl-starch containing Medicines: Introduction of new measures to protect patients

Active substance hydroxyethyl starch, HES

to the article

2018.07.31

Dear Doctor Letter (Rote-Hand-Brief) on Spinraza (nusinersen): Communicating hydrocephalus not related to meningitis or bleeding reported

Active substance nusinersen

PDF306KB

2018.07.20

Retinoids: Updated measures for pregnancy prevention as well as warnings on neuropsychiatric disorders after oral use

Active substance acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, tretinoin

to the article

2018.07.17

Valsartan: Impurity in the active substance

Active substance valsartan

to the article

2018.07.06

Information letter on Fiasp® (insulin aspart): New colour scheme for cartridges and pre-filled pens

Active substance insulin aspart

PDF291KB

2018.07.05

Dear Doctor Letter (Rote-Hand-Brief) on finasteride: Risk of sexual dysfunction and psychiatric symptoms

Active substance finasterid

PDF2MB

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