Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2018 – 29.12.2018

20.12.2018

(Updated08.01.2019)

Allergan Limited

Allergan Textured Breast Implants and Tissue Expanders 
Model: see FSN 
Lot: see FSN

MD: Silicone gel/saline-filled breast implant, Tissue expander

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181220_17

27.12.2018

(Updated08.01.2019)

Cook Endoscopy/Wilson-Cook Medical, Inc.

AcuSnare Polypectomy Snare 
Model: ASDB-15-015-S and ASDB-25-015-S 
Lot: Lots manufactured in 2018

MD: Rigid polypectomy snare, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181227_24

20.12.2018

(Updated07.01.2019)

Unomedical a/s

Medtronic MiniMed Mio Advance Infusion Set 
Model: MMT-212, MMT-233, MMT-242, MMT-242600, MMT-242T, MMT-247, MMT-247600, MMT-247T, and MMT-248 
Lot: all

MD: Electric infusion pump administration set, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181219_11

21.12.2018

(Updated07.01.2019)

Natus Medical Incorporated

neoBLUE blanket Phototherapy LED System

MD: Blanket/pad infant phototherapy unit

DE-1 
FR-1 
EN-1 

Vk_20181220_07

20.12.2018

(Updated04.01.2019)

Medtronic Navigation Inc.

StealthAir Percutaneous Pin Adapter 
Model: 9734752 
S/N: All

MD: Multi-purpose stereotactic surgery system

FR-1 
EN-1 

Vk_20181219_17

21.11.2018

(Updated04.01.2019)

Olympus Medical Systems Corp.

Various Olympus endoscope models 
Model: See FSN 
Lot: See FSN

MD: Flexible endoscope

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181114_38

27.12.2018

(Updated04.01.2019)

Limacorporate S.p.a.

REVISION femoral neck, H60mm 
Model: 7515.15.110 – 7515.15.010 
Lot: 201617984 (sterilization number 1700041), 201613282 (sterilization number 1600276)

MD: Revision coated femoral stem prosthesis

DE-1 
FR-1 
IT-1 

Vk_20181221_07

28.12.2018

(Updated04.01.2019)

Wellspect HealthCare

Navina Rectal Catheter set regular 
Model: 68940XX 
Lot: 427790, 427296, 427474, 427789, 427221, 427476, 427122

Navina rectal catheter regular + associated device 
Model: 68940 
Lot: 426044, 426366, 426540, 426741, 426889, 427217, 427703

Navina Consumable set regular 
Model: 69003XX 
Lot: 427312, 427850, 427473, 427530, 427628, 427154, 427602, 427128

Navina Classic System regular 
Model: 69005XX 
Lot: 427501, 427890

Navina Classic System regular – refill 
Model: 69006XX 
Lot: 427761

Navina Smart System regular 
Model: 69009XX 
Lot: 427678, 427446, 427416, 427169, 427365, 427134

MD: Rectal irrigation system catheter

MD: Rectal irrigation system catheter

MD: Rectal irrigation kit

MD: Manual rectal irrigation system

MD: Manual rectal irrigation system

MD: Powered rectal/colostomy irrigation system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181227_11

12.12.2018

(Updated03.01.2019)

Roche Diagnostics GmbH

COBAS INTEGRA 400 plus

cobas c 111

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

IVD: Clinical chemistry analyser

DE-1 
FR-1 
EN-1 

Vk_20181204_10

18.12.2018

(Updated03.01.2019)

Integra LifeSciences

Mayfield Skull Clamp 
Model: A1059, A1108, A1114, A1117, A2000, A2114, A3059 
Lot: All lots sold between 2004 – 2015

MD: Skull clamp

DE-1-End User 
FR-1-End User 
IT-1-End User
EN-1-Distributor 
EN-1-End User 

Vk_20181214_35

24.01.2018

(Updated28.12.2018)

Beckman Coulter, Inc.

COULTER EPICS XL Flow Cytometer, COULTER EPICS XL-MCL Flow Cytometer, FC 500 Series Flow Cytometers 
Lot: N/A 
S/N: All

IVD: Flow cytometry analyser IVD, semi-automated

DE-EPICS_1 
DE-FC500_1 
DE-FC500_2a 
DE-FC500_2b 
FR-EPICS_1 
FR-FC500_1 
FR-FC500_2a
IT-FC500_1 
IT-FC500_2a 
EN-EPICS_1 
EN-FC500_1 
EN-FC500_2a 
EN-FC500_2b 

Vk_20180122_09

28.12.2018

Philips Medical Systems Nederland BV

Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion 
Model: See PDF-file “EN-Model number”

Panorama HFO, Ingenia, SmartPath to dStream, Multiva, Prodiva, MR-OR, MR-RT, MR-Linac, MR-Marlin systems 
Model: See PDF-file “EN-Model number”

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

DE-1 
FR-1 
IT-1 
EN-1 
EN-Model number 

Vk_20181228_11

28.12.2018

Philips Medical Systems Nederland BV

Ingenia Elition X 
Model: 781357, 781358 
SW-Version: R5.5.0

MD: Full-body MRI system, superconducting magnet

FR-1 
IT-1 
EN-1 

Vk_20181220_15

20.12.2018

(Updated28.12.2018)

Abbott Ireland Diagnostic Division

ARCHITECT Rubella IgM 
Model: 6C18-25 
Lot: 90059FN00

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181219_10

28.12.2018

Zimmer GmbH

Allofit Alloclassic, polar screw plug, M8 
Model: 01.00004.001 
Lot: 2955750

MD: Acetabular shell

FR-1 
IT-1 

Vk_20181228_10

28.12.2018

Volcano Corporation

version 2.5 FFR/iFR software 
Model: 435-0602.48;435-0602.48 
SW-Version: 2.5

MD: Cardiovascular ultrasound imaging system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181221_11

27.12.2018

Abbott

Alinity i Processing Module 
Model: 03R65-01 
S/N: Ai01001 – Ai01455, Ai01457, Ai01459

IVD: Chemiluminescent immunoassay analyser IVD, automated

EN-1 

Vk_20181227_09

27.12.2018

Applied Medical Resources Corporation

Epix Electrosurgical Probe with Smoke Evacuation, Angled L-Hook Tip 
Model: CW002; 101470783 
Lot: 1336418 and 1340206

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181227_07

27.12.2018

Ottobock SE & Co. KGaA

Push/Mag valve 
Model: see FSN 
Lot: all 
S/N: all

MD: Stumpf Ventil

DE-1 

Vk_20181218_14

27.12.2018

Dräger Medical AG & Co. KGaA

Einweg-Atemschlauchsysteme 
Model: see FSN

MD: Tubing

DE-1 
FR-1 
IT-1 

Vk_20181227_19

27.12.2018

Biomet Orthopaedics, LLC

Max VPC Tray Base & Max VPC Screw Caddy Brackets 
Model: 231201002; 231201003 
Lot: 453392, 453918, 453919, 469917, 475577, 481064, 481065, 486820, 498695, 506818, 512867, 512868

MD: Instrument tray

DE-1 
EN-1 

Vk_20181221_09

27.12.2018

Balt Extrusion

ECLIPSE2L 
Model: ECL2L 6X20 
Lot: 00321583 and 00332661

MD: Intravascular occluding catheter, image-guided

EN-1 

Vk_20181227_17

05.12.2018

(Updated25.12.2018)

Agfa Healthcare

DX-D 600

MD: Stationary basic diagnostic x-ray system, digital

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

Vk_20181127_09

17.12.2018

(Updated21.12.2018)

Ethicon Endo-Surgery, LLC

PROXIMATE HCS Hemorrhoidal Circular Stapler 
Model: PPH01, PPH03 
Lot: See FSN

MD: Haemorrhoidal surgical stapler, single-use

DE-1.0 
EN-1.0 

Vk_20181207_04

21.12.2018

Hitachi High Technologies Corporation (HHT)

cobas 8100 system 
Model: 07123841001, 07123850001 
S/N: 1301-01,1302-02,1302-07,1302-03,1302-04,1302-05,1302-06

IVD: Specimen processing instrument IVD, automated

EN-1 

Vk_20181211_12

21.12.2018

Beckman Coulter, Inc.

UniCel DxI 600 Access Immunoassay System 
Model: A30260, A71460, A71461, A92060 
SW-Version: 5.2, 5.3.0, 5.3.1

UniCel DxI 800 Access Immunoassay System 
Model: 973100, A71456, A71457, A84545, A25288, A25285 
SW-Version: 5.2, 5.3.0, 5.3.1

UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems 
Model: A64871, A64903, A64935, A59102 
SW-Version: 5.2, 5.3.0, 5.3.1

IVD: Immunoassay analyser

IVD: Immunoassay analyser

IVD: Clinical chemistry analyser for special purpose

FR-1 
EN-1 

Vk_20181210_10

20.12.2018

W.O.M. World of Medicine GmbH

PNEUMOCLEAR 
Model: ST296 / 0620050200 
Lot: 4011926 bis 4013513

MD: Endoscopic insufflation tubing set, single-use

DE-1.0 
FR-1.0 
EN-1.0 

Vk_20181129_06

18.12.2018

(Updated19.12.2018)

GE Medical Systems

Signa Ovation with Excite & 0.7T Signa OpenSpeed, Signa Ovation HD, Signa HDe, 1.5T Signa HDxt, Brivo MR355 & Optima MR360, Signa Creator & Signa Explorer

Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO

MD: Full-body MRI system, superconducting magnet

MD: Full-body MRI system, superconducting magnet

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181213_06

19.12.2018

Mattes-Instrumente GmbH

Reprocessable surgical instruments

MD: various reprocessable surgical instruments

DE-1.0 

Vk_20181029_02

19.12.2018

Leica Microsystems (Schweiz) AG

Leica M220 F12 
Model: 10448367

MD: General-purpose surgical microscope

EN-1 

Vk_20181214_05

18.12.2018

Nipro Corporation

Surdial X 
SW-Version: 1.453

MD: Haemodialysis system, institutional

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181212_03

18.12.2018

CIVCO Medical Instruments CO

L25 Needle Guide Bracket 
Lot: see FSN

MD: Nonimplantable needle guide, single-use

EN-1 

Vk_20181218_07

18.12.2018

Elekta, Inc

Multi-ACCESS 
SW-Version: 6.1 and higher

MOSAIQ 
SW-Version: 1.0 and higher

MD: Radiation therapy treatment record/verify system application software

MD: Patient health record information system application software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181211_13

18.12.2018

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_20181214_04

11.12.2018

(Updated14.12.2018)

LivaNova USA, Inc.

VNS Therapy SenTiva Generator 
Model: 1000 
S/N: All

AIMD: Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181205_01

14.12.2018

Philips Medical Systems

HeartStart MRx 
Model: M3538A 
S/N: Lithium-Ion Batteries manufactured between 2017-12-28 and 2018-03-20 with serial numbers 17362-0001-P through 18057-0266-P

MD: Rechargeable professional automated external defibrillator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181214_30

11.12.2018

(Updated14.12.2018)

Diffuplast srl

ExactaMix 
Model: E1402OD,E1405OD,E1405OD5 
Lot: H069FB, H069FC, H071NC

MD: bags for parenteral nutrition

FR-1 
EN-1 

Vk_20181206_02

23.10.2018

(Updated13.12.2018)

Sofradim Production

Parietex Composite Parastomal Mesh 
Model: PCOPM15 & PCOPM20 
Lot: see FSN

MD: Abdominal hernia surgical mesh, composite-polymer

DE-1 
DE-2 
FR-1 
IT-1 
IT-2 
EN-1 

Vk_20181017_03

13.12.2018

GE Healthcare Finland Oy

CARESCAPE Monitor B450, B650, B850

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181213_08

12.12.2018

Hologic, Inc.

I-View Contrast Enhanced Digital Mammography 
Model: ASY-08109 
S/N: non-serialized software license. All units affected

MD: Stationary mammographic x-ray system, digital

DE-1 

Vk_20181210_09

12.12.2018

Terumo BCT, Inc.

Spectra Optia Apheresis System 
Model: 61000 
S/N: All

MD: Apheresis system

DE-1 

Vk_20181207_28

12.12.2018

CAIR LGL

vaccuum stop valve

MD: Suction system tubing

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181122_10

12.12.2018

Randox Laboratories Ltd

Calcium 
Model: CA3871, CA8309, CA8021 
Lot: not lot specific

IVD: Calcium (Ca2+) IVD, kit, spectrophotometry

DE-1 
FR-1 
EN-1 

Vk_20181204_06

12.12.2018

Medtronic Inc.

Medtronic StrataMR Adjustment Tool Kit 
Model: 45905 
Lot: 00000, 000004, 000013, 000039, 000041, 000045, 000053, 000054, 000063, 000070, 000076, 000081, 000086, 000092

MD: Cerebrospinal fluid shunt valve programmer

DE-1 
EN-1 

Vk_20181109_07

12.12.2018

Thermo Fisher Scientific Microbiology Perth

ThermoScientific Oxoid BRILLIANCE ESBL/Brilliance CRE Bi-Plate 
Model: PO1265E 
Lot: 2442472

IVD: MICROBIOLOGY (CULTURE)

FR-1 
EN-1 

Vk_20181205_03

12.12.2018

Terumo BCT, Inc.

Trima Accel System 
Model: 81000 
S/N: All

MD: Apheresis system

DE-1 

Vk_20181207_29

12.12.2018

Randox Laboratories Ltd

Fructosamine Calibrators and Controls 
Model: FR2993, FR2994, FR2996 
Lot: 498FR, 499FR and 500FR

IVD: Fructosamine IVD, control

DE-1 
FR-1 
EN-1 

Vk_20181204_05

05.12.2018

(Updated11.12.2018)

Roche Diagnostics GmbH

Bilirubin Total Gen.3 
Model: see FSN

Lactate 
Model: see FSN

LACT2 
Model: see FSN

IgM-2 
Model: see FSN

IVD: Total bilirubin IVD, kit, spectrophotometry

IVD: Lactate IVD, kit, enzyme spectrophotometry

IVD: Lactate IVD, kit, enzyme spectrophotometry

IVD: Immunoglobulin M kit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181203_01

11.12.2018

B.BRAUN MEDICAL

Celsite Safety 
Model: 4437612, 4437617 
Lot: 36924796, 36925036, 36927141, 36927821, 36928982, 36929358, 36930721, 36931983, 36933954, 36934652, 36937822, 36938890, 36935843

MD: Infusion/injection port, implantable

DE-1 

Vk_20181210_01

11.12.2018

GE Healthcare Finland Oy

CARESCAPE Monitor B850

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181210_02

11.12.2018

Schiller AG

CARDIOVIT MS-2007; MS-2010; MS-2015 
Model: 0A.101000 3.900790 Standart 3.900792 WLAN 0.090000 3.900800 Standart 3.900805 WLAN 3.900804 WLAN/GSM 0A.100000 3.900810 Standart 3.900829 Standart 2014 3.900812 WLAN/GSM 3.900830 WLAN/GSM 2015 3.900833 WLAN 
S/N: all

MD: Electrocardiograph, professional, multichannel

DE-1 
FR-1 
IT-1 

Vk_20181126_03

11.12.2018

Microtek Medical, Inc.

Instrument Arm Drape 
Model: 420015-03 
Lot: D173337A

Disposable Accessory Kit 
Model: 420290-03, 420291-03 
Lot: D172757, D173077, D173177, D173267, D173447, D173517, D173607

MD: Medical equipment drape, single-use, sterile

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

EN-1 

Vk_20181207_06

27.11.2018

(Updated10.12.2018)

HeartWare Inc.

Medtronic HeartWare HVAD Battery Charger 
Model: 1600 
S/N: BCH000401 – BCH098862

AIMD: Implantable ventricular circulatory assist system

DE-1 
EN-1 

Vk_20181127_01

10.12.2018

Gebr. Brasseler GmbH & Co. KG

Sawblades for bone surgery for single use -STERILE 
Model: KMS2213.07F. KMS1909.52R.;REF 71.34.0089 REF 71.34.0692 
Lot: 292850 (for Model KMS2213.07F.) 292853 (for Model KMS1909.52R.) 
S/N: n.a. 
SW-Version: n.a.

MD: Sawblades for bone surgery for single use

DE-1.0 
FR-1.0 

Vk_20181025_04

05.12.2018

(Updated10.12.2018)

TODA PHARMA

TODA AMNIODIAG 5 strip and TODA AMNIODIAG 5 cassette 
Model: 1052, 1050 
Lot: 1805151S, 1807061S, 1805151, 1807061

IVD: Other Specific Proteins RT & POC

FR-1 
EN-1 

Vk_20181203_15

21.08.2017

(Updated10.12.2018)

Covidien LLC

Covidien Emprint Percutaneous Antenna with Thermosphere Technology 
Model: CA15L1, CA20L1, CA30L1, CA15L2, CA20L2, CA30L2 
Lot: See FSN

MD: Microwave hyperthermia system applicator, intracorporeal; Microwave ablation system probe

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

Vk_20170814_11

20.12.2017

(Updated10.12.2018)

Cardiac Pacemaker Inc

VALITUDE CRT-P 
Model: U125, U128 
S/N: All

MOMENTUM CRT-D 
Model: G124, G125, G126, G128, G138

AUTOGEN CRT-D 
Model: G172, G173, G175, G177, G179 
S/N: All

INOGEN CRT-D 
Model: G140, G141, G146, G148 
S/N: All

VISIONIST CRT-P 
Model: U225, U226, U228 
S/N: All

VIGILANT CRT-D 
Model: G224, G225 , G228, G237, G247, G248 
S/N: All

CHARISMA CRT-D 
Model: G324, G325, G328, G337, G347, G348 
S/N: All

DYNAGEN CRT-D 
Model: G150, G151, G156, G158 
S/N: All

ORIGEN CRT-D 
Model: G050, G051, G056, G058 
S/N: All

RESONATE CRT-D 
Model: G424, G425, G426, G428, G437, G447, G448, G524, G525, G526, G528, G537, G547, G548 
S/N: All

AIMD: Cardiac resynchronization therapy implantable pacemaker

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable pacemaker

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

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

Vk_20171213_13

09.12.2018

Cardinal Health

Protexis Neoprene Surgical Glove 
Model: 2D73DP55, 2D73DP60, 2D73DP65, 2D73DP70, 2D73DP75, 2D73DP80, 2D73DP85, 2D73DP90 
Lot: TS18060249, TS18070244, TS18080021, TS18080344, TS18090280 TS18060125, TS18060250, TS18060328, TS18070031, TS18070245, TS18070392, TS18080025, TS18080345, TS18080444, TS18090119, TS18090281 TS18050409, TS18060149, TS18060240, TS18060312, TS18070036, TS180 
SW-Version: N/A

: Polychloroprene surgical glove, non-powdered

EN-1.0 

Vk_20181114_10

09.12.2018

Datex Ohmeda

Carescape R860

MD: Neonatal/adult intensive-care ventilator

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20181126_11

07.12.2018

ACUTRONIC Medical Systems AG

fabian Therapy evolution 
S/N: prefix: AT 
SW-Version: All software versions

Fabian HFO 
S/N: prefix: AH / AK / AI / AL / 20 
SW-Version: All software versions

fabian +nCPAP evolution 
S/N: prefix: AN 
SW-Version: All software versions

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181109_10

28.03.2018

(Updated06.12.2018)

Stryker Medical Kalamazoo

POWER LOAD 
Model: 6390 
Lot: Units manufactured between 01.01.2016 and 16.08.2017

MD: Ambulance stretcher, manual

DE-1 
DE-2 
FR-2 
IT-2 
EN-1 

Vk_20180319_10

06.12.2018

GE Healthcare

Centricity Universal Viewer 
SW-Version: Issue #1: 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, Issue #2: 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, SP9, SP9.0.1

MD: Medical image management system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181205_05

06.12.2018

Siemens Healthcare GmbH; Business Area Advances Therapies

Sensis System 
SW-Version: VD10B

MD: Cardiac catheterization laboratory computer

FR-1 

Vk_20181203_08

04.12.2018

Elekta, Inc

MOSAIQ 
SW-Version: 2.64 SP9 and higher

MD: Patient health record information system application software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181203_06

04.12.2018

Implant Direct Sybron Manufacturing LLC

Interactive Precision IO Scan Adapter 
Model: 6534-09PT 
Lot: 104479, 104963

MD: Dental implant suprastructure, temporary, preformed, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181129_02

03.12.2018

Waldemar Link GmbH & Co. KG

MP-Prosthesis stem, XS-0, L=160 
Model: 172-916/12 
Lot: all after manufacturing date 2013-10 
S/N: all after manufacturing date 2013-10

MD: Press-fit hip femur prosthesis, modular

DE-1 
EN-1 

Vk_20181126_02

28.11.2018

(Updated03.12.2018)

Diagnostica Stago

STACLOT LA 
Model: 00600 
Lot: 251918 (Expiry date: 2019-03-31), 252751 (Expiry date: 2019-09-30)

IVD: Lupus anticoagulant kit

FR-1 
EN-1 

Vk_20181121_12

21.11.2018

(Updated03.12.2018)

Biohit Oyj

Lactose intolerance quick test 
Model: 602010, 602012 
Lot: 12LA1802, 16LA1803, 21LA1804, 30LA1805, 31LA1806, 31LA1807, 38LA1809

IVD: Lactase IVD, kit, immunochromatographic test (ICT), rapid

DE-1 
EN-1 
EN-2 
EN-3 

Vk_20181116_12

29.11.2018

(Updated30.11.2018)

Abbott Ireland Diagnostics Division

Alinity i TSH, Alinity i Free T4, Alinity i Free T3, Alinity i Total T3, Alinity i Total ß-hCG, Alinity i Estradiol, Alinity i Progesterone Reagent Kits 
Model: see FSN 
Lot: see FSN

Alinity i B12, Alinity i Folate, Alinity i Ferritin, Alinity i 25-OH Vitamin D, Alinity i STAT High Sensitive Troponin- I Reagent Kits 
Model: see FSN 
Lot: see FSN

IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)

IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181122_08

21.11.2018

(Updated30.11.2018)

Philips Medical Systems DMC GmbH

CombiDiagnost 
Model: 709030 
SW-Version: 1.0.0, 1.0.1 and 1.0.2

MD: Radiographic/fluoroscopic unit, mobile

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181116_21

14.11.2018

(Updated30.11.2018)

Randox Laboratories Ltd

Evidence Investigator 
Model: EV3602, EV3602R, EV4187 
Lot: not applicable 
SW-Version: V2.0

IVD: Multiplex analyser IVD, laboratory, semi-automated

FR-1 
EN-1 

Vk_20181112_13

20.11.2018

(Updated28.11.2018)

Gambro Lundia AB

CWP 800 RO1 220-240V/ 380-415V 50Hz, CWP 800 HW 220-240V/ 380-415V 50Hz, Clinic Panel 
Model: 115641, 115642, 115645, 115942

MD: Haemodialysis system, institutional/home-use

DE-1 
FR-1 
EN-1 

Vk_20181119_07

27.11.2018

MAQUET Cardiopulmonary GmbH

HCU40 
Model: 70104.4054; 70105.4917 
S/N: All serial numbers below S/N 90441598 
SW-Version: 1.2.3.0

MD: Cardiopulmonary bypass system heat exchanger

EN-1 

Vk_20181126_10

26.11.2018

RaySearch Laboratories AB

RayStation 
Model: 3.5, 4.0, 4.5, 4.7, 5, 6, 7, 8A

MD: Radiation therapy software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181116_02

06.11.2018

(Updated23.11.2018)

IBL International GmbH

Androstenedione 
Model: DB52161 
Lot: 180700 and 182140

IVD: Androstenedione kit

DE-1 
EN-1 

Vk_20181102_09

23.11.2018

BONESUPPORT AB

CERAMENT G 
Model: A0450

CERAMENT BONE VOID FILLER 
Model: A0210

CERAMENT V 
Model: A0451

MD: Bone matrix implant, synthetic

MD: Bone matrix implant, synthetic

MD: Bone matrix implant, synthetic

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181116_19

18.10.2018

(Updated19.11.2018)

Maquet Critical Care AB

SoKINOX / SERViNO 
Model: 6694550 / 6881700

MD: Nitric oxide delivery unit, system-based

EN-1 
EN-2 

Vk_20181011_04

02.11.2018

(Updated19.11.2018)

General Medical Merate S.p.A.

Xsense DR

MD: Stationary basic diagnostic x-ray system, digital

DE-1 
EN-1 

Vk_20181012_11

18.11.2018

Philips Healthcare

Brilliance 6, Brilliance 10, Brilliance 16 and 16 Power, Brilliance 40, Brilliance 64 
Model: 728231, 728235, 728240, 728246, 728251, 728256 
S/N: see FSN

MD: Full-body CT system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181118_01

14.11.2018

Ohmeda Medical a division of Datex-Ohmeda

Giraffe OmniBed Carestation 
S/N: see FSN

Giraffe Incubator Carestation 
S/N: see FSN

Giraffe Warmer 
S/N: see FSN

Panda iRes Warmer 
S/N: see FSN

MD: Conventional infant incubator

MD: Conventional infant incubator

MD: Infant warmer

MD: Infant warmer

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181106_03

14.11.2018

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH

Artelac Rebalance EDO /Artelac Rebalance SDU 
Lot: 779146, 779167

MD: Eye lubricant

DE-1 
FR-1 
IT-1 

Vk_20181102_10

14.11.2018

Hanse-Medizintechnik Dipl. Ing. P. Hettmer GmbH

Thekla II 
Model: 4-02-00 / 4-03-00 
S/N: 402XXXXXXX / 403XXXXXXX

MD: Chairs, Rehabilitation

DE-1 
EN-1 

Vk_20181109_05

14.11.2018

Ohmeda Medical a division of Datex-Ohmeda

Giraffe OmniBed Carestation

MD: Conventional infant incubator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181109_26

14.11.2018

Fast Track Diagnostics Luxembourg S.à.r.l.

FTlyo 2+.1 Respiratory pathogens 21 plus; FTlyo 2P.3 Respiratory pathogens 33; FTlyo 48.1 FLU/HRSV v.2; FTlyo 56.1 HCoV v.1

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

EN-1 

Vk_20181112_05

14.11.2018

HOYA Corporation

PENTAX Video Duodenoscope 
Model: ED-3490TK and ED34-i10T

MD: Flexible video duodenoscope

DE-1.0 
EN-1.0 

Vk_20180517_10

13.11.2018

Zimmer, Inc.

Various Trauma Guide Wires 
Model: 00-2228-024-00, 00-2255-025-00, 00-2255-026-00, 47-2237-033-00, 47-2237-037-00, 472237-038-00, 47-2255-008-00, 47-2255-008-01, 47-2490-097-00, 47-2490-097-01, 47-2490-098-00, 47-2490-098-01, 00-2228-024-00 
Lot: All lots expiring prior to September 30, 2023

MD: Orthopaedic prosthesis implantation instrument, reusable; Orthopaedic prosthesis implantation instrument, single-use; Orthopaedic bone wire

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181108_12

13.11.2018

Drägerwerk AG & Co.KGaA

Fabius GS/ GS premium/ MRI/ Plus/ Plus XL/ Tiro 
Model: all

MD: Anaesthesia units

DE-1 
FR-1 

Vk_20181112_10

13.11.2018

MHMedical Tec GmbH

OncoSet Y Link Mono 
Model: 91487 
Lot: 2018-13395

MD: Intravenous Administration Sets, General-Purpose

DE-1 

Vk_20181106_07

13.11.2018

Bard Peripheral Vascular, Inc.

BARD ePTFE Small Beading Vascular Graft Products: DISTAFLO, DISTAFLO Mini Cuff, DYNAFLO, IMPRA, IMPRA CARBOFLO 
Model: see FSN 
Lot: all

MD: Synthetic vascular graft

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20181102_11

13.11.2018

Zimmer, Inc.

NexGen Distal Femoral Augment Block 
Model: 00-5990-035-23 
Lot: 62925336

MD: Knee arthroplasty wedge

DE-1 
FR-1 
EN-1 

Vk_20181109_16

13.11.2018

Alere Scarborough, Inc.

Alere BinaxNOW Legionella with the Alere Reader 
Model: 852-012, 852-100, LFR-000;852-012, 852-100, LFR-000 
Lot: All 
S/N: All

IVD: Legionella pneumophila antigen IVD, kit, immunochromatographic test (ICT), rapid

EN-1.0 

Vk_20181031_17

31.10.2018

(Updated12.11.2018)

Linkage Biosciences Inc.

LinkSeq HLA ABCDRDQA1DQB1/ABCDRDQDP+/SABR/DRDQDP 
Model: 1550C, 1575C, 1580C, 1861C, 1862C 
Lot: see FSN

IVD: Human leukocyte antigen typing kit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181029_05

12.11.2018

Medtronic Navigation Inc.

Visualase Thermal Therapy System 
Model: 9735542 
S/N: All

MD: MRI-guided laser interstitial thermal therapy system

DE-1 
DE-2 
FR-1 
FR-2 
IT-1 
IT-2 

Vk_20181101_03

24.07.2018

(Updated12.11.2018)

Ortho Clinical Diagnostics

VITROS Immunodiagnostic Products NT-proBNP Reagent Pack 
Model: 6802156 
Lot: Applicable to all expired, in-date and future lots.

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

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 
DE-2 
EN-1 
EN-2 

Vk_20180723_08

31.10.2018

(Updated12.11.2018)

Ortho Clinical Diagnostics Inc.

VITROS 3600, 4600, 5600, 7600 & 5,1FS 
Model: VITROS 3600: 6802783, 6802914; VITROS 4600: 6802445; VITROS 5600: 6802413, 6802915; VITROS 7600: 6844461; VITROS 5,1FS: 6801375 
SW-Version: see FSN

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

DE-(3600)d1 
DE-(5600)d1 
EN-(3600)e1 
EN-(4600)e1 
EN-(5,1FS)e1
EN-(5600)e1 
EN-(7600)e1 

Vk_20181023_19

12.11.2018

proxomed Medizintechnik GmbH

compass 530 
Model: 10090800

MD: Exerciser, chest

DE-1 

Vk_20181105_07

09.11.2018

Abiomed Europe GmbH

Impella CP 
Model: all

Impella 2.5 
Model: all

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181023_14

08.11.2018

Zimmer GmbH

Avenir Muller Stem 
Model: 01.06010.001 
Lot: 2955599 
S/N: N/A 
SW-Version: N/A

MD: Coated hip femur prosthesis, modular

DE-1 
EN-1 

Vk_20181031_15

07.11.2018

Datex Ohmeda

Aisys 
S/N: all 
SW-Version: 11.00, 11 SP01

Aisys CS2 
S/N: all 
SW-Version: 11.00, 11 SP01

MD: Anaesthesia workstation, general-purpose

MD: Anaesthesia workstation, general-purpose

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181106_05

07.11.2018

Cardiac Pacemaker Inc

SQ-RX S-ICD 
Model: SQ-RX Model 1010 
Lot: all devices are implanted 
S/N: All

AIMD: Single-chamber implantable defibrillator

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181106_01

09.10.2018

(Updated05.11.2018)

TiLite LCC

TiLite 
Model: Aero R, Aero T, Aero X, Aero Z, TRA, Twist, ZRA, 2GX 
S/N: M2034037

MD: Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

DE-1 
FR-1 
IT-1 
EN-1_Distributor 
EN-1_End User 

Vk_20181002_11

23.10.2018

(Updated05.11.2018)

Roche Diabetes Care GmbH

Accu-Chek Insight 
Model: 00700006889 
S/N: All Accu-Chek Insight insulin pumps with serial numbers lower than 32100000

MD: Ambulatory insulin infusion pump, electronic

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181022_19

24.10.2018

(Updated02.11.2018)

LivaNova SAS

Heater-cooler (1T), Heater-cooler 3T, FlexTherm 
Model: 16-02-50, 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85, 16-02-95;Model number 
Lot: N/A 
S/N: All 
SW-Version: N/A

MD: Cardiopulmonary bypass system heating/cooling unit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181022_24

24.10.2018

(Updated02.11.2018)

bioMerieux Inc

VITEK 2 AST-ST01, ST02, ST03 
Model: 410028, 420915, 421040 
Lot: All lots

IVD: General-microorganism antimicrobial susceptibility culture medium IVD

DE-1 
FR-1 
EN-1 
EN-2 

Vk_20181017_08

12.09.2018

(Updated02.11.2018)

RECIPE Chemicals + Instruments GmbH

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

IVD: Other Other Clinical Chemistry Reagents

EN-1 
EN-2 
EN-2 

Vk_20180910_08

01.11.2018

The Binding Site Group Ltd

Human IgM Kit for use on SPAPLUS 
Model: NK012.S 
Lot: 413849

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181026_10

22.08.2018

(Updated31.10.2018)

Siemens Healthcare Diagnostics Inc.

ADVIA Autoslide Wright-Giemsa Stain 
Model: 08096536, SMN 10327568 
Lot: See FSN

ADVIA Autoslide Modified Wright’s Stain 
Model: 08100142, SMN 10327576 
Lot: See FSN

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

IVD: Wright-Giemsa staining solution IVD

IVD: Wright staining solution IVD

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

Vk_20180814_16

31.10.2018

Telemis

Telemis-Medical 
SW-Version: All versions up to 4.80-u01.4

MD: Picture archiving and communication system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181031_13

31.10.2018

Medtronic Navigation Inc.

Synergy Cranial, StealthStation Cranial 
Model: 9733763, 9735585 
S/N: All of below listed software versions (see section 8) 
SW-Version: see section 8 comments for details

MD: Neurological stereotactic surgery system

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20181022_23

31.10.2018

STEPHANIX

X-ray remote controlled system 
Model: D2RS, DX-D800, VISIONARY DRF 
S/N: All

MD: Basic diagnostic x-ray system table, powered

DE-1.0 
FR-1.0 

Vk_20181019_18

31.10.2018

Iris Diagnostics, a Division of Iris International

iChem VELOCITY Urine Chemistry Strips 
Model: 800-7212, 800-7204 
Lot: see FSN

IVD: Urine rapid test device, multiple-constituent

DE-1 
FR-1 
EN-1 

Vk_20181024_11

31.10.2018

Philips Healthcare – Andover

Philips HeartStart FR3 AED 
Model: 861388; 861389 
S/N: See UAL86100190 
SW-Version: NA

AIMD: Non-rechargeable public automated external defibrillator

DE-1 
FR-1 
EN-1 

Vk_20181025_05

31.10.2018

GE Healthcare Finland Oy

B20i, B40i Patient Monitors

B20, B40, B125 / B105 Patient Monitors

MD: Single-patient physiologic monitoring system

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181029_03

24.10.2018

(Updated31.10.2018)

Siemens Medical Solutions USA, Inc.

Biograph Horizon and Biograph mCT 
Model: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10507786, 10528954, 10528955, 10528956, 10528958, 10529158, 10529159, 10529160, 10529161, 10532746, 10532748, 10534159, 10534160

MD: PET/CT system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181016_11

31.10.2018

Siemens Healthcare Diagnostics Inc

Lactate Dehydrogenase Flex reagent cartridge 
Model: K2054; SMN 10464323 
Lot: all

IVD: Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry

DE-1 
FR-1 
EN-1 

Vk_20181023_18

31.10.2018

Siemens Healthcare Diagnostics Inc

Dimension Vista Intelligent Lab System 
Model: Dimension Vista 1500: 10444802, 10459469; Dimension Vista 500: 10488224, 10488217 
SW-Version: 3.7 and 3.8.1

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

DE-1 
FR-1 
EN-1 

Vk_20181031_04

30.10.2018

OSCOR Inc.

OSCOR TB-II Temporary Bipolar Pacing Lead

MD: Temporary cardiac pacing/stimulation connection cable, single-use

DE-1 

Vk_20181030_01

24.10.2018

(Updated29.10.2018)

Abbott

ARCHITECT HAVAb IgG 
Model: see FSN 
Lot: see FSN

ARCHITECT HAVAb IgM 
Model: see FSN 
Lot: see FSN

Alinity i HAVAB IgG 
Model: see FSN 
Lot: see FSN

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

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

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

DE-1 
FR-1 
EN-1 

Vk_20181018_13

17.10.2018

(Updated29.10.2018)

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 
FR-1 
IT-1 
EN-1 

Vk_20181015_09

24.10.2018

(Updated29.10.2018)

Horiba ABX SAS

ABX Pentra Lipase CP 
Model: A11A01631 / 1220001631

IVD: Lipase IVD, kit, enzyme spectrophotometry

DE-1 
FR-1 
EN-1 

Vk_20181016_13

26.10.2018

Intuitive Surgical, Inc

da Vinci EndoWrist Monopolar Curved Scissors 
Model: 470179-17 ; 470179-18 ; 420179-20 
Lot: Manufacturing date 2018-04-17 to 2018-08-31, Distribution date 2018-06-04 to 2018-08-31

MD: Robotic electrosurgical instrument, monopolar, reusable

DE-1 
FR-1 
EN-1 

Vk_20181008_06

26.10.2018

CODAN Medizinische Geräte GmbH & Co KG

CODAN Infusion Devices 
Model: 43.3905, 43.4240, 43.4270, 43.4333, 43.4435 
Lot: see FSN

MD: Infusion Pump Administration Sets

DE-1 
EN-1 

Vk_20181026_09

23.10.2018

(Updated26.10.2018)

Xiros Limited

MPFL System Implant Set 
Model: 102-1060 
Lot: 321133

MD: Ligament prosthesis

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181018_07

20.07.2018

(Updated25.10.2018)

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 
DE-3 – Distributor 
DE-3 – Endnutzer 
FR-1 
FR-2 – autres produits 
FR-3 – Distributeurs
FR-3 – Utilis. Fineaux 
IT-1 
IT-2 – ult. prodotti 
IT-3 – Distributori 
EN-1 
EN-2 – add. Products 
EN-3 – additional lots 

Vk_20180709_08

22.10.2018

(Updated25.10.2018)

GE Medical Systems

DASH Patient Monitor

Solar 8000M/I

Solar 9500

MD: Single-patient physiologic monitoring system

MD: Single-patient physiologic monitoring system

MD: Single-patient physiologic monitoring system

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

Vk_20181022_04

24.10.2018

(Updated25.10.2018)

Abbott

ARCHITECT Free T3 (FT3) assay 
Model: 7K63-20/25/30/35/27/32/37 
Lot: All 
SW-Version: N/A

Architect Total T3 Reagent Kit 
Model: 7K64-20/25/30/35/27/32/37 
Lot: All 
SW-Version: N/A

IVD: Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

IVD: Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

DE-A1 
DE-B1 
FR-A1 
FR-B1 
IT-A1 
IT-B1 
EN-A1 
EN-B1 

Vk_20181016_06

18.10.2018

(Updated25.10.2018)

MAQUET Cardiopulmonary GmbH

Quadrox-i 
Model: 70104.8599; 70104.8600; 70104.6979; 70104.7003 
Lot: All Lot(s) manufactured between October 2016 and October 2018, with an expiration date of October 2018 and October 2020 
S/N: N/A 
SW-Version: N/A

MD: Extracorporeal membrane oxygenator

DE-1 
EN-1 
EN-2 

Vk_20181012_18

24.10.2018

(Updated25.10.2018)

Abbott

Alinity Free T3 Reagent Kit and Alinity Total T3 Reagent Kit 
Model: 07P6920, 07P6930 and 07P9420, 07P9430 
Lot: All 
SW-Version: N/A

IVD: Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

DE-1 
FR-1 
EN-1 

Vk_20181016_05

25.10.2018

Siemens Healthcare GmbH; Business Area Advanced Therapies

ARTIS ZEE CEILING

MD: Stationary angiographic x-ray system, digital

DE-1 
EN-1 

Vk_20181012_03

25.10.2018

Siemens Medical Solutions USA, Inc.

Symbia Evo Excel 
Model: 10910501

MD: Stationary gamma camera system

DE-1 

Vk_20181017_02

24.10.2018

ICU Medical, Inc.

IV sets 
Model: F29, F29K, F30, SN1003, SN1064;F29, F29K, F30, SN1003, SN1064 
Lot: Please see FSN

MD: Fluid transfer set, general-purpose

DE-1 
EN-1 

Vk_20181022_21

18.10.2018

(Updated24.10.2018)

Jarvik Heart Inc

Jarvik 2000 Ventricular Assist System components 
Model: JHI-212, JHI-202, JHI-201, JHI-204

AIMD: External ventricular circulatory assist system, external cable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181010_03

23.10.2018

(Updated24.10.2018)

Illumina, Inc

VeriSeq NIPT Solution 
Model: 15076164, RH-300-1001 
SW-Version: Workflow Manager Software versions 1.4 and 1.5

IVD: Human genomic analysis interpretive software

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181015_12

24.10.2018

Philips Medical Systems DMC GmbH

DigitalDiagnost 
Model: 712027, 712028, 712029, 712031, 712032, 712033, 712224, 712225, 712226, 712227, 712228 
S/N: according to UAL 
SW-Version: 4.1.x and 4.2.x

MD: Stationary basic diagnostic x-ray system, digital

DE-1 
FR-1 
EN-1 

Vk_20181018_09

23.10.2018

(Updated23.10.2018)

Herbert Waldmann GmbH & Co.

UV-Therapiesystem 7100 
S/N: 70511 bis einschliesslich 71847

MD: Lights, Ultraviolet, Other

DE-1 
EN-1 

Vk_20181023_05

23.10.2018

Medtronic Navigation Inc.

O-arm O2 Surgical Imaging System 
Model: BI70002000, BI70002000R 
S/N: all

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181019_06

23.10.2018

General Medical Merate S.p.A.

X-ray system table

MD: Stationary basic diagnostic x-ray system, digital

DE-1 
FR-1 
IT-1 

Vk_20181002_12

23.10.2018

Medline International France SAS

Sterile Procedure Trays including Kocher clamps 
Model: ZGZTH009, ZGZTH009A, ZGZTH009B

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

FR-1 
EN-1 

Vk_20181017_07

17.10.2018

(Updated22.10.2018)

Biomerieux

API NH 
Model: 10400 
Lot: Listed in Table 1 in Annex

IVD: Multiple Neisseria species culture isolate identification IVD, kit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181010_09

10.10.2018

(Updated22.10.2018)

ClearStream Technologies Ltd.

LifeStream Stent 
Model: All LifeStream Devices 
Lot: See FSN

MD: Iliofemoral artery endovascular stent-graft

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

Vk_20181004_04

21.10.2018

Endologix International Holdings B.V.

Nellix, Endovascular Aneurysm Sealing System 
Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, N10-190, N10-200 NP-002; NP-004; NP-001; NP-003; NP-005; NX-001, NX-002a;N/A 
Lot: N/A 
S/N: N/A 
SW-Version: N/A

MD: Abdominal aorta endovascular stent-graft

EN-1.0 

Vk_20181015_13

21.10.2018

bioMérieux SA

NUCLISENS Lysis Buffer 
Model: N/A;280134 
Lot: Z019EA1LB 
S/N: N/A 
SW-Version: N/A

IVD: Nucleic acid extraction/isolation kit IVD

DE-1.0 
EN-1.0 

Vk_20181009_11

09.10.2018

(Updated19.10.2018)

Medtronic MiniMed

Medtronic MiniMed 640G Insulin Pump 
Model: MMT-1711, MMT-1712 
S/N: All serial numbers distributed from December 2017 with software version 4.10 
SW-Version: 4.10

MD: Ambulatory insulin infusion pump, electronic

DE-1 
FR-1 
IT-1 
EN-1 
EN-Serial Numbers 

Vk_20181004_05

19.10.2018

Becton, Dickinson & Company

BD MAX CLINICAL 
Model: 441916 
S/N: See FSN

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

FR-1 
EN-1 

Vk_20181012_10

19.10.2018

PINA-MEDIZINTECHNIK-VERTRIEBS AG

TROCHILUS Titan TLIF Cage 
Model: TT27.06.0.S – TT36.12.8.S 
Lot: all

MD: Metallic spinal fusion cage, sterile

DE-1 

Vk_20181012_12

14.11.2017

(Updated19.10.2018)

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 
FR-3 

Vk_20170728_06

10.10.2018

(Updated19.10.2018)

VIRCELL

HEPATITIS E VIRCLIA IgM MONOTEST 
Model: VCM067

IVD: HEV Antibody IgM

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181004_12

18.10.2018

ICU Medical, Inc.

THERMOSET Closed-Loop Injectable Delivery system 
Model: 011-41423-03 and 011-41424-03 
Lot: 3585765 and 3585777, 3598038, 3627756, 3643150

MD: Blood stream indicator injector, mechanical

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181018_01

10.10.2018

(Updated17.10.2018)

Siemens Healthcare Diagnostics Inc.

RAPID Point 500 Blood Gas Analyzer 
Lot: N/A 
S/N: All serial numbers that have either V2.2, V2.3, or V2.3.1 software 
SW-Version: V2.2, V2.3, or V2.3.1

IVD: Blood gas/haemoximetry analyser IVD, point-of-care

DE-1 
FR-1 
EN-1 

Vk_20181005_06

10.10.2018

(Updated16.10.2018)

Medeco BV

Curion Curisoft 
Model: 8204, 8208, 8210, 8212, 8240, 8242, 8246 
Lot: Products manufactured between 2013-07-01 and 2018-06-30

MD: Catheters, Urinary, Urethral, Drainage, Intermittent

DE-1 
FR-1 
EN-1 

Vk_20181002_08

03.10.2018

(Updated16.10.2018)

Welch Allyn Inc

Connex Spot Monitor 
Model: see fsn

MD: Multiple physiological parameter spot-check analysis system, clinical

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180928_04

30.07.2018

(Updated15.10.2018)

B. Braun Melsungen AG

Perifix Catheter Connector 
Lot: see FSN

MD: Luer adaptor

DE-1 
DE-2 
FR-1 
FR-2 
IT-1 
IT-2 

Vk_20180716_11

07.08.2018

(Updated15.10.2018)

Biomet Orthopaedics, LLC

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

MD: Femur nail, sterile

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

Vk_20180802_24

15.10.2018

Accuray Incorporated (Madison)

CyberKnife 
Model: CyberKnife M6

MD: Linear accelerator system

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20181003_06

07.09.2018

(Updated15.10.2018)

Haemonetics S.A.

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

MD: Apheresis system tubing set

FR-1 
FR-2 

Vk_20180831_18

15.10.2018

Randox Laboratories Ltd

Liquid Cardiac Control 
Model: CQ5051, CQ5052, CQ5053 
Lot: n/a 
S/N: All

IVD: Multiple cardiac marker IVD, control

DE-1.0 
FR-1.0 
IT-1.0 

Vk_20181005_09

09.10.2018

(Updated15.10.2018)

Ascensia Diabetes Care Holdings AG

Contour Next Blood Glucose Test Strips

CONTOUR XT Blood Glucose Meter

IVD: Glucose IVD, kit, enzyme spectrophotometry, rapid

IVD: Home-use/point-of-care blood glucose monitoring system IVD

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181009_03

11.10.2018

(Updated12.10.2018)

icotec ag

Drill, AO Coupling, Ø 3 mm for 13 mm screw 
Model: 39-3-13 
Lot: 12/01, 14/01

MD: Fluted surgical drill, reusable

DE-1 
EN-1 

Vk_20181010_06

12.10.2018

Etac Supply Center AB

Cross

MD: Wheelchair

DE-1 
FR-1 
IT-1 

Vk_20181004_08

03.10.2018

(Updated11.10.2018)

Leica Biosystems Melbourne Pty Ltd

BOND Slide Labeler Zebra Printer Power Supply Unit (PSU) for use with BOND-III and BOND-MAX instruments 
Model: Zebra TLP3842, Zebra GX430t

IVD: Ink printer

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180926_07

11.10.2018

Abbott

Alinity ci-series System Control Module (SCM) 
Model: 03R70-01 
SW-Version: Versions 1.00, 1.01, 1.02, 1.03, 1.10 and 2.00

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
EN-1 

Vk_20181005_01

10.10.2018

SPINEART SA

ROMEO 2 PAD 
Model: PAD-IM WT 12-S 
Lot: see FSN

MD: Interspinous spinal fixation implant

DE-1 
EN-1 

Vk_20181008_01

02.10.2018

(Updated10.10.2018)

TriVascular Inc, a wholly owned subsidiary of Endologix Inc.

Ovation Abdominal Stent Graft System Platform 
Model: TV-AB2080-D, TV-AB2380-D, TV-AB2680-D, TV-AB2980-D, TV-AB3480-D, TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I

MD: Abdominal aorta endovascular stent-graft

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180928_02

10.10.2018

Smiths Medical ASD, Inc.

Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes 
Model: BRC270, BRC275 BRC280, BRC285, BRC290,BRCA70, BRCA75, BRCA80, BRCA85, BRCA90 
Lot: ALL

MD: Tracheostomy tube cannula, single-use

EN-1 

Vk_20181005_03

02.10.2018

(Updated09.10.2018)

Fannin UK Ltd

Espiner Tissue Retrieval System 
Model: Master E-Sac (RoboSac); EMP112WG-6 
Lot: A1796, A1822, A1832, A1886, A2154, A2978, A2997, A3017, A3348, A3364, 1254, 1667, 2051, 2193, 2480, 2845

MD: Tissue extraction bag

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180918_04

17.10.2016

(Updated08.10.2018)

Ortho Clinical Diagnostics

VITROS Intact PTH Reagent and Calibrator 
Model: 6802892, 6802893 
Lot: 0700 (Expiry 18-Oct-16), 0710 (Expiry 14-Nov-16), 0728 (Expiry 12-Dec-16), 0738 (Expiry 02-Jan-17), 0748 (Expiry 06-Feb-17), 0758 (Expiry 06-Mar-17), 0768 (Expiry 10-Apr-17), and: see FSNs

IVD: Intact parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

DE-1 
DE-2 
DE-3 
EN-1 
EN-2 
EN-3 

Vk_20161010_03

08.10.2018

Maquet

Cardiosave Hybrid/Rescue IABP 
Model: IABP 0998-xx-0800-xx 
S/N: All serial numbers distributed March 6, 2012 through August 31, 2018

MD: Intra-aortic balloon pump

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180926_05

08.10.2018

ekamed GmbH & Co. KG

ekamove 30° Seitenlagerungssystem 
SW-Version: V3.37

MD:

EN-1 

Vk_20181008_07

03.10.2018

(Updated08.10.2018)

Abbott

ARCHITECT HAVAb IgG 
Model: 6C29-22, 6C29-27 
Lot: 90356LI00, 90360LI00

Alinity i HAVAB IgG 
Model: 8P26-32 
Lot: 90385LI00

ARCHITECT HAVAb IgM 
Model: 6C30-22, 6C30-27 
Lot: 90228LI00, 91012LI00, 90227LI00, 91013LI00

IVD: Hepatitis A virus immunoglobulin G kit

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

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181002_03

08.10.2018

RaySearch Laboratories AB

RayStation 
Model: RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7

MD: Radiation therapy software

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180926_11

25.07.2018

(Updated06.10.2018)

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

DE-1.0 
FR-1.0 
EN-1.0 

Vk_20180720_12

03.10.2018

(Updated04.10.2018)

BridgeMaster medical Limited

BridgeMaster medical Fetal Scalp Blood Sampling Kits 
Model: FBS-AC, FBS-W

MD: Foetal blood sampling kit, scalp

DE-1 
EN-1 

Vk_20180928_01

03.10.2018

Schaerer Medical AG

Shoulder arthroscopy plate for schaerer axis 
Model: 90568 / 90569

MD: Universal operating table top

DE-1 
FR-1 
EN-1 

Vk_20181001_03

03.10.2018

Permobil AB

Permobil 
Model: M300 PS, C300 PS, C350 PS

MD: Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

Vk_20180821_08

26.09.2018

(Updated03.10.2018)

Roche Diagnostics GmbH

Elecsys FT4 III 
Model: 07976836190, 07976887190 
Lot: 304692-xx/331797-xx, 304694-xx/331807-xx/356756-xx

IVD: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

DE-1 
FR-1 
EN-1 

Vk_20180918_09

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

02.10.2018

Orthofix s.r.l.

Drill Bit 
Model: see FSN 
Lot: see FSN

MD: Fluted surgical drill, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180926_06