Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2019 – 31.03.2019

Опубліковано 27.06.2019 о 11:52

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

 

 

 

 

 

DE-1.0 

Vk_20180821_02

28.03.2019

EBR Systems Inc.

WiSE CRT Transmitter 
Model: 4100

AIMD: Pacemaker, implantable

EN-1 

Vk_20190325_17

28.03.2019

Beckman Coulter Biomedical GmbH

DxA 5000 
Model: B87352 
Lot: Not applicable 
S/N: All 
SW-Version: 1.0.13 and 1.0.14

IVD: Specimen processing instrument IVD, automated

DE-1 
EN-1 

Vk_20190325_16

26.03.2019

(Updated28.03.2019)

Geistlich Pharma AG

Geistlich Bio-Oss Pen 
Model: 30661.1, 30662.1, 30671.1 
Lot: no specific lot/batch number(s) affected

MD: Dental bone matrix implant, animal-derived

DE-1-Anwender 
DE-1-Distributor 
FR-1-Distributeurs
FR-1-Utilisateur 
IT-1-Distributori 
IT-1-Utente 
EN-1-Distributors 
EN-1-User 

Vk_20190320_01

13.03.2019

(Updated28.03.2019)

Randox Laboratories Ltd

Liquid Cardiac Control 
Model: CQ5051, CQ5052, CQ5053 
Lot: 4243CK, 4244CK, 4245CK

IVD: Multiple cardiac marker IVD, control

DE-1 
FR-1 
EN-1 

Vk_20190308_15

27.03.2019

Philips Medical Systems Nederland BV

Uro Diagnost Eleva 
Model: see FSN

Multi Diagnost Eleva 
Model: see FSN

OmniDiagnost Classic 
Model: see FSN

OmniDiagnost Eleva 
Model: see FSN

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

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

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

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190321_12

27.03.2019

Siemens Healthcare Diagnostics Inc.

Atellica Solution IM 1300 Analyzer and Atellica Solution IM 1600 Analyzer 
Model: SMN 11066001; SMN 11066000 
SW-Version: see FSN

Atellica Sample Handler Prime 
Model: SMN 11069001 
SW-Version: see FSN

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
EN-1 

Vk_20190319_35

27.03.2019

Thermo Fisher Scientific Microbiology Perth

Thermo Scientific Oxoid Brilliance Staph 24 Agar 
Model: PO1186A 
Lot: 2581635

IVD: Chromogenic Staphylococcus aureus agar culture medium IVD

DE-1 
EN-1 

Vk_20190319_32

19.03.2019

(Updated27.03.2019)

Vyaire Medical

enFlow Disposable IV Fluid/Blood Warmer Cartridge 
Model: 200 (980200EU), 202 (980202EU)

MD: Convection blood/fluid warmer set

DE-1 
FR-1 
EN-1 

Vk_20190313_10

26.03.2019

HELLMUT RUCK GmbH

Podolog Stella 2 / 3 
Model: 10011, 10127, 10128 
S/N: See FSN

MD: Chairs, Examination/Treatment

DE-1 

Vk_20190326_07

26.03.2019

Covidien LLC

Endo Clinch II 
Model: 174317 
Lot: see FSN

Endo Grasp 
Model: 173030 
Lot: see FSN

MD: Flexible endoscopic grasping forceps, single-use

MD: Flexible endoscopic grasping forceps, single-use

DE-1 
FR-1 

Vk_20190325_21

26.03.2019

Draeger Medical Systems, Inc.

Infinity Acute Care System 
SW-Version: VG7.0.1

Infinity 
Model: M540 
SW-Version: VG7.0.1

MD: Single-patient physiologic monitoring system

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 

Vk_20190321_07

25.03.2019

(Updated26.03.2019)

Meda Pharma S.p.A.

Endwarts classic 
Model: bottle with white cap

MD: Wart-removal material

DE-1 
FR-1 
IT-1 

Vk_20190320_05

25.03.2019

Bühlmann Laboratories AG

IBDoc 
Model: component: IBDoc Portal, LF-IBDOC8 
SW-Version: 3.1.9 and earlier

IVD: Other Other Specific Proteins

EN-1 

Vk_20190319_01

25.03.2019

Philips Medical Systems Nederland BV

Allura Xpe 
Model: 708037, 708038 , 722001, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722020, 722023, 722026, 722027, 722028, 722029, 722031, 722035, 722038, 722039, 722058 and 722400

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

DE-1.0 
FR-1.0 
EN-1.0 

Vk_20190314_05

20.03.2019

(Updated25.03.2019)

Hitachi High Technologies Corporation (HHT)

ProCell II M 
Model: 06908799190

cobas 8000 
Model: cobas 8000 modular analyzer series

cobas e 801 module 
Model: see FSN

IVD: Wash/cleaning solution IVD, automated/semi-automated system

IVD: Multi-modality clinical specimen analysis system IVD

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190312_15

13.03.2019

(Updated25.03.2019)

LivaNova Deutschland GmbH

Heater-Cooler System 3T 
Model: 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85 
S/N: all

MD: Cardiopulmonary bypass system heating/cooling unit

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190308_06

22.03.2019

Balt Extrusion

SILK VISTA BABY 
Model: All 
Lot: All

MD: Bare-metal intracranial vascular stent

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190318_03

20.03.2019

(Updated22.03.2019)

Tosoh Corporation

ST AIA-PACK ACTH 
Model: 025221 
Lot: all

ST AIA-PACK Homocysteine 
Model: 025226 
Lot: all

IVD: Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)

IVD: Homocysteine IVD, reagent

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190318_01

13.03.2019

(Updated22.03.2019)

BioFire Diagnostics, LLC

FilmArray Gastrointestinal (GI) Panel 
Model: RFIT-ASY-0104 / RFIT-ASY-0116 
Lot: All lots with expiration date of 23 October 2019 onward

IVD: Multiple Parameters – Infect. Immunology

DE-2 
FR-2 
EN-1 
EN-2 

Vk_20190306_16

22.03.2019

MGB Endoskopische Geräte GmbH Berlin

GRP handle 
Model: 429-77015, 429-77015N, 429-77020, 429-77020N, 429-77030, 429-77030N 
Lot: AE..AQ

MD: Handpieces, Surgical

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190306_02

20.03.2019

Mikrogen GmbH

recomLine Helicobacter 2.0 IgG/IgA 
SW-Version: recomScan 3.4

IVD: H. pylori Antibody Assays

EN-1 

Vk_20190319_02

19.03.2019

(Updated20.03.2019)

Teleflex Malaysia

RUSCH Catheter Mount, RUSCH Connectors (Bulk) for Breathing Circuits 
Model: see fsn 
Lot: see fsn

Gibeck HME Filter + Catheter Mount 
Model: see fsn 
Lot: see fsn

MD: Catheter mount, single-use

MD: Heat/moisture exchanger/microbial filter, sterile

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190315_01

20.03.2019

Beckman Coulter Biomedical GmbH

DxA 5000 
Model: B87352 
Lot: Not applicable 
S/N: All

IVD: Specimen processing instrument IVD, automated

DE-1 
EN-1 

Vk_20190313_19

20.03.2019

Herbert Waldmann GmbH & Co.

UV-Therapiesystem UV 3003

MD: Lights, Ultraviolet, Other

DE-1 

Vk_20190306_12

19.03.2019

ArthroCare Corporation

SmartStitch PerfectPasser Connector 
Model: OM-8010 
Lot: see FSN

MD: Suture/needle passer, reusable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190318_12

19.03.2019

Mathys AG Bettlach

balanSys Femur Holder 
Model: 71.34.1014 
Lot: 2247596

MD: Joint prosthesis implantation kit, reusable

DE-1 
FR-1 
EN-1 

Vk_20190314_03

19.03.2019

Olympus Medical Systems Corp.

SINGLE USE SUCTION VALVE 
Model: MAJ-209, 028978 
Lot: 88H, 89H, 8XH, 8YH, 8ZH, 91H

MD: Endoscopic procedure air/water valve, single-use

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190314_01

18.07.2017

(Updated19.03.2019)

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur XPT System 
Model: 10711433 
S/N: All serial numbers manufactured from May 2014 to present.

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1.0 
FR-1.0 

Vk_20170210_01

13.03.2019

(Updated18.03.2019)

Abbott

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

Level Sensor, Bulk Solution 
Model: 04S68-01 
S/N: all

Accessory kit, Alinity i 
Model: 03R66-01, 03R66-02 
S/N: all

Accessory kit #2, Alinity c 
Model: 03R69-01, 03R69-02 
S/N: all

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

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

Vk_20190311_09

13.03.2019

(Updated18.03.2019)

Microgenics Corporation

MAS ChemTRAK H Assayed Control Level 3 
Model: CHA-3 
Lot: CHA19073

IVD: Multiple clinical chemistry analyte IVD, control

DE-1 
EN-1 

Vk_20190311_06

18.03.2019

Medtronic Inc.

Pulmonary Vein Catheter GOLD (PVAC GOLD) 
Model: 990078 
Lot: All

MD: Cardiac mapping/radio-frequency ablation catheter, single-use

EN-1.0 

Vk_20190306_05

15.03.2019

B. Braun Melsungen AG

Certofix Quattro 
Model: see FSN 
Lot: see FSN

MD: Central venous catheter

DE-1 

Vk_20190312_04

13.03.2019

(Updated15.03.2019)

Roche Diagnostics GmbH

ALBP – Albumin BCP 
Model: 05975573190 
Lot: 35651401

IVD: Albumin kit

DE-1 
EN-1 

Vk_20190305_27

15.03.2019

PARI GmbH

PARI LC SPRINT Tracheo 
Model: 023G1080 
Lot: 1000061062

MD: Tracheostomy mask, aerosol

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190305_22

13.03.2019

Mathys AG Bettlach

Mod. rev. neck lateral with screw 60 
Model: 52.34.0021 
Lot: 2239710; 2238537

MD: Artificial hip joint, total

DE-1 
FR-1 
EN-1 

Vk_20190312_12

13.03.2019

GE ULTRASOUND Korea, Ltd

Logiq P5 and Logiq A5 
Model: BT06/BT08

MD: General-purpose ultrasound imaging system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190307_09

13.03.2019

Medovent GmbH

Reaxon Direct 
Model: RD121, RD130, RD140, RD150, RD160

Reaxon Nerve Guide 
Model: RG321, RG330, RG340, RG350, RG360

MD: Nerve guide, bioabsorbable, animal-derived

MD: Nerve guide, bioabsorbable, animal-derived

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190306_14

11.03.2019

(Updated12.03.2019)

Thoratec (Abbott)

HeartMate 3 Coring Tool 
Model: 10005872 
Lot: All products are affected 
S/N: N/A 
SW-Version: N/A

AIMD: Implantable ventricular circulatory assist system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190304_08

06.03.2019

(Updated12.03.2019)

DiaSys Diagnostic System GmbH

CRP FS 
Model: 1 7002… 
Lot: 23996

IVD: C-Reactive Protein IC RT/POC => 12.70.11.01

DE-1 
EN-1 

Vk_20190301_11

12.03.2019

Etac AS, Etac Supply Gjovik

Molift 2-point Sling Bar 
Model: 1430016, 1430017, 1430021, 1830001, 183002, 183002C, 1830003 
S/N: N/A

MD: Mobile patient lifting system, battery-powered

DE-1 
FR-1 
IT-1 

Vk_20190228_05

03.03.2019

(Updated12.03.2019)

Hamilton Medical AG

Hamilton-C6 
Model: 160021 
S/N: All

MD: Ventilators, Intensive Care

DE-1 
FR-1 
FR-1 
EN-1 

Vk_20190221_12

05.03.2019

(Updated11.03.2019)

Nabtesco

ALLUX 
Model: NE-Z4, NE-Z4SH 
S/N: From CL05105 to CL05192, from CN05107 to CN07119, from CM05108 to CM05134, from CP05104 to CP05138

MD: microprocessor controlled prosthetic knee joint

DE-1 
FR-1 
EN-1 

Vk_20190228_15

31.10.2016

(Updated11.03.2019)

Medtronic Inc.

Charging System, RestoreSensor Charging System used for Activa and Restore 
Model: 37751 rechargers sold in kit model 37651, 37754, 97754 Charging systems

AIMD: External device battery charger

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

Vk_20161018_02

05.03.2019

(Updated08.03.2019)

Eurotrol B.V.

Eurotrol Hemoglobin Controls 
Model: 022.002.002, 022.003.002, 202.002.002, 202.003.002, 253.002.002, 253.003.002 
Lot: 81102, 82403, 25302811, 25303824

IVD: Multiple haemoglobin subtype IVD, control

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190227_11

06.03.2019

(Updated07.03.2019)

Abbott

Alinity i Processing Module 
Model: 03R65-01 
S/N: All

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

Alinity s System 
Model: 06P16-01 
S/N: All

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1 (Alinity i, c) 
FR-1 (Alinity i, c) 
IT-1 (Alinity i, c) 
EN-1 (Alinity i, c) 
EN-1 (Alinity s) 

Vk_20190304_05

26.02.2019

(Updated07.03.2019)

Abbott Laboratories

CELL-DYN Emerald Analyzer 
Model: 09H39-01 
S/N: All Serial numbers below 7765 
SW-Version: N/A

IVD: Haematological cell analyser IVD, automated

DE-1 
FR-1 
EN-1 

Vk_20190225_10

07.03.2019

Laboratoires Anios

Endoscopic module 
Model: 404 / 404288 – 404380 
S/N: 621 to 1026

MD: Endoscope washer/disinfector

DE-1 
FR-1 
IT-1 

Vk_20190222_15

12.02.2019

(Updated07.03.2019)

Cordis Corporation

Cordis Vista Brite Tip 
Model: See FSN 
Lot: See FSN

ADROIT Guiding Catheter 
Model: See FSN 
Lot: See FSN

MD: Vascular guide-catheter, single-use

MD: Vascular guide-catheter, single-use

DE-1 
FR-1 
IT-1 
EN-1 
EN-2 

Vk_20190208_18

05.03.2019

MicroVention Europe S.A.R.L.

LifePearl microspheres 
Model: 8LP2S200 
Lot: 17032021, 17121811V

MD: Embolization particle, non-bioabsorbable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190226_08

05.03.2019

PROTEC GmbH & Co. KG

PROVERT 
Model: 7401-5-

MD: X-Ray bucky wall stand

DE-1 
EN-1 

Vk_20190219_10

05.03.2019

PROTEC GmbH & Co. KG

PROGNOST ES / PROGNOST FS / PROGNOST SH 
Model: 704x-5- ,70xx-5- , 7040-5-

MD: X-ray system tube support, floor stand

DE-1 
EN-1 

Vk_20190219_08

04.03.2019

William Cook Europe ApS

Vena Cava Filter Sets 
Model: See attached list 
Lot: All lot numbers

MD: Vena cava filter, temporary/permanent

EN-1.0 

Vk_20190225_07

04.03.2019

Philips Medical Systems

Xper Flex Cardio Physiomonitoring System 
Model: 722458 
S/N: see FSN 
SW-Version: 1.5.16.0322 and 1.6.1.0390

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
EN-1 

Vk_20190118_20

04.03.2019

Philips Medical Systems (CLE), Inc

Ingenuity TF PET/MR 
Model: 882456;882456 
S/N: 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027. 
SW-Version: 4.0.2

MD: PET/MRI system

FR-1 
EN-1 

Vk_20190114_08

04.03.2019

Liko AB

Strap Gripper 
Model: 3136250

MD: Patient lifting system

EN-1 

Vk_20190111_08

28.02.2019

B. Braun Medical AG

ANAESTHESIE OPHTA 
Model: 15460 
Lot: 18142M52, 18252M59, 18343M73

MD: Anesthesia Set

DE-1 

Vk_20190227_02

28.02.2019

B. Braun Avitum AG

Dialog iQ HDF comfort 
Model: 710407A 
SW-Version: 1.03.00

MD: Haemodialysis system

DE-1 
FR-1 

Vk_20190225_38

28.02.2019

Applimed SA

Cannula needle 
Model: 8001769 
Lot: 18.09.19

MD: Cannulae

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190121_01

19.02.2019

(Updated27.02.2019)

Regen Lab SA

RegenKit-BCT-3T, RegenKit-BCT-2A, RegenKit-BCT-4 
Model: RK-BCT-3T, RK-BCT-2A, RK-BCT-4 
Lot: RK-BCT-3T: 006; RK-BCT-2A: 024; RK-BCT-4: 019

MD: Haematological concentrate system kit, platelet concentration

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190208_22

22.02.2019

(Updated27.02.2019)

Medacta International SA

GMK UNI Femur 
Model: size 3 – non anatomic version: 02.08.0003; size 4 – non anatomic version: 02.08.0004 
Lot: size 3 (02.08.0003): 070924, 080221, 082174, 083387, 090647, 092150, 092991, 102937, 103938, 104394, 110623, 112137, 112683, 114335; size 4 (02.08.0004): 070923, 080222, 082173, 083385, 090646, 091365, 103652, 104393

MD: Uncoated unicondylar knee femur prosthesis

DE-1 
FR-1 
IT-1 
EN-1a 
EN-1b 

Vk_20190207_01

26.02.2019

Brainlab AG

Spine & Trauma 3D Navigation 1.0 
Model: 26509B; 22268C; 26663 
SW-Version: Spine & Trauma 3D Navigation 1.0

MD: Robotic surgical navigation system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190225_34

26.02.2019

Siemens Healthcare GmbH

SOMATOM Definition AS 
SW-Version: VB10A and Option “Dual Spiral Dual Energy”

SOMATOM Confidence 
SW-Version: VB10A and Option “Dual Spiral Dual Energy”

SOMATOM Edge Plus 
SW-Version: VB10A and Option “Dual Spiral Dual Energy”

SOMATOM Definition Edge 
SW-Version: VB10A and Option “Dual Spiral Dual Energy”

MD: Full-body CT system

MD: Full-body CT system

MD: Full-body CT system

MD: Full-body CT system

DE-1 
FR-1 

Vk_20190225_08

26.02.2019

Luminex Molecualr Diagnostics, Inc.

xTAG Gastrointestinal Pathogen Panel (GPP) 
Model: I032C0324 
Lot: IK032C-1044, IK032C-1045, IK032C-1046, IK032C-1047, IK032C-1048, IK032C-1049

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

EN-1 

Vk_20190220_07

25.02.2019

Stryker Medical

Lifepak 15 
Model: Model: V15-2-000XXX; Catalogue: 99577-00XXXX
Lot: see FSN

MD: Physiologic-monitoring defibrillation system

DE-1 
FR-1 
IT-1 

Vk_20190218_03

13.02.2019

(Updated25.02.2019)

Brahms GmbH, part of Thermofisher Scientific

BRAHMS uE3 KRYPTOR 
Model: 803.075 
Lot: 03111

IVD: Trisomy 21-risk hormone IVD, kit, fluorescent immunoassay

DE-1 
EN-1 

Vk_20190207_04

13.02.2019

(Updated25.02.2019)

Abbott Ireland Diagnostics Division

ARCHITECT Estradiol Reagent Kit 
Model: 7K72-20; 7K72-25; 7K72-35 
Lot: All

Alinity i Estradiol Reagent Kit 
Model: 07P5020; 07P5030 
Lot: All

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

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

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190206_08

31.12.2018

(Updated25.02.2019)

Autonomic Technologies Inc. (ATI)

Pulsante SPG Microstimulator System

AIMD: Hand-held deep-tissue electromagnetic stimulator

DE-1 
FR-1 
EN-1 

Vk_20181217_03

23.10.2017

(Updated22.02.2019)

Radiometer Basel AG

TCM5 
Model: 393-500 (Flex/Basic) 
S/N: All serial numbers

MD: Transcutaneous blood gas monitoring system

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

Vk_20171010_11

21.02.2019

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

Uroskop Omnia 
Model: 10094910

Uroskop Omnia Max 
Model: 10762473

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

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

DE-1 
EN-1 

Vk_20190215_11

20.02.2019

Ohmeda Medical a division of Datex-Ohmeda

Panda iRes Warmer 
S/N: See FSN

MD: Infant warmer

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190220_16

20.02.2019

Elcon Medical Instruments GmbH

Laparoskopie Handgriff mit HF-Anschluss 
Model: 231-00-000 und 231-00-010 
Lot: see FSN

MD: Forceps, Electrosurgical

DE-1 

Vk_20190213_15

19.02.2019

Sequent Medical Inc.

WDC – WEB Detachement Controller 
Model: WDC-1 
Lot: 18072301

MD: Embolization prosthesis, intravascular

DE-1 
FR-1 
EN-1 

Vk_20190219_02

19.02.2019

Ardo medical AG

TULIPS 
Model: 63.00.284, 63.00.285 
Lot: Smaller than 190086

MD: Nipple shield, reusable

DE-1 
EN-1 

Vk_20190215_14

19.02.2019

Datex Ohmeda

Carescape R860 
Model: 2066713-001(single pack), 2083208-001 (10 pack) 
Lot: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130

MD: Neonatal/adult intensive-care ventilator

DE-1 
FR-1 
IT-1 

Vk_20190215_07

19.02.2019

Spacelabs Healthcare

Smart Disclosure 
Model: 92810 
SW-Version: ICS 5.00, 5.01, 5.02, 5.03

MD: Medical equipment clinical data interfacing software

DE-1 
FR-1 
IT-1 

Vk_20190215_04

19.02.2019

Amplitude S.A.S.

EVOK femoral stem Standard 
Model: 1-0192008, 1-0192108 
Lot: all batches

MD: Coated hip femur prosthesis, modular

FR-1 
EN-1 

Vk_20190214_11

19.02.2019

Siemens Medical Solutions USA, Inc., Ultrasound

Acuson NX2 , NX2 Elite, NX3, NX3 Elite 
Model: 11284381,11362069,11235612,11235411 
SW-Version: See FSN

MD: General-purpose ultrasound imaging system

DE-1 
FR-1 
IT-1 

Vk_20190214_05

19.02.2019

GeneOhm Sciences Canada, Inc.

BD MAX Enteric Bacterial Panel 
Model: 442963 
Lot: 8194784, 8199682

IVD: Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1 
FR-1 
IT-1 

Vk_20190213_14

19.02.2019

WEST Pharma. Services IL, Ltd.

Vial2Bag Needleless Transfer Device 
Model: 6070101 
Lot: A451

MD: Fluid transfer set, general-purpose

DE-1 
EN-1 

Vk_20190213_03

19.02.2019

GE Healthcare

CHA Anesthesia and CHA Critical Care 
Model: NA;NA 
Lot: NA 
S/N: FI1075CA01, K1900AB 
SW-Version: CHA 5.0

MD: Patient health record information system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190212_13

19.02.2019

Aesculap AG

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM 
Model: NP462R

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1 

Vk_20190212_05

19.02.2019

BD Switzerland Sàrl

Alaris VP Plus with Guardrails 
Model: 9003MED01-G, 9003TIG01-G, 9003TIG03-G 
S/N: All

MD: General-purpose infusion pump, line-powered

DE-1 
FR-1 
IT-1 

Vk_20190206_05

21.01.2019

(Updated18.02.2019)

GE ULTRASOUND KOREA, LTD

Logiq P6 
Model: BT07 and BT09

MD: General-purpose ultrasound imaging system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190111_20

18.02.2019

Hamilton Medical AG

HAMILTON-G5/S1 ventilator unit 
Model: HAMILTON-G5 159001, HAMILTON-S1 159005 
S/N: < 16192 
SW-Version: < 2.80

MD: Ventilators, Intensive Care

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20180417_08

07.02.2019

(Updated14.02.2019)

Stago

STA – VWF:Rco 
Model: 01191 
Lot: 202469; 202470; 202473; 202474

IVD: von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, kit, nephelometry/turbidimetry

DE-1 
EN-1 

Vk_20190129_02

14.02.2019

Ascensia Diabetes Care Holdings AG

Contour Next Blood Glucose Test Strips 
Model: Einfuhr, Vertrieb / Importation, Distribution / Importazione, Distribuzione: APS Arzneimittel-Parallelimport-Service AG, 6330 Cham

IVD: Glucose IVD, kit, enzyme spectrophotometry, rapid

DE-en+DE 1 
FR-en+FR 1 
IT-en+IT 1 

Vk_20190110_05

13.02.2019

Randox Laboratories Ltd

Immunoassay Premium, Immunoassay Premium Plus, Liquid Immunoassay Premium 
Model: IA3109, IA3112, IA2633, IA2638, LIA3105 
Lot: 1714EC, 430312, 432364, 440941, 1720EC, 1723EC

IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)

EN-1 

Vk_20190206_12

05.02.2019

(Updated13.02.2019)

megro GmbH & Co. KG

Ratiomed H. pylori 
Lot: MEG 254085, MEG 254086, MEG 254087

IVD: H. pylori – RT & POC

DE-1 
EN-1 

Vk_20190129_17

03.07.2018

(Updated13.02.2019)

Roche Diagnostics GmbH

cobas p 612 pre-analytical system 
Model: 07563116001 
SW-Version: All versions from 2.0 and higher

IVD: Specimen processing instrument IVD, automated

DE-1 
FR-1 
EN-1 
EN-2 

Vk_20180628_12

12.02.2019

Bucher Leichtbau AG

EMS Stretcher 
Model: 1354100 
S/N: all

MD: Ambulance stretcher, manual

EN-1 

Vk_20190212_07

12.02.2019

Edwards Lifesciences Services GmbH

Edwards Commander Delivery System 
Model: 9610TF20, 9610TF23, 9610TF26, 9610TF29 
Lot: All Commander Delivery Systems with remaining shelf life

MD: Aortic transcatheter heart valve bioprosthesis, stent-like framework

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190208_21

12.02.2019

Gebrüder Martin GmbH & Co. KG

smartPen 
Model: REF 80-210-21-04 und REF 80-210-23-04

MD: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

DE-1 
EN-1 

Vk_20190201_08

11.02.2019

I2A

SIRweb 
Model: Module SIRweb MaldiTOF 
SW-Version: All

IVD: Specific Microbiology / Epidemiology Software

DE-1 
FR-1 

Vk_20190130_15

06.02.2019

(Updated11.02.2019)

Philips Medical Systems

Philips PageWriter TC Cardiographs (TC20/30/50/70) 
Model: TC20/30/50/70 
Lot: NA 
SW-Version: All with software revisions up to and including A.07.05.22.

MD: Electrocardiograph, professional, multichannel

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190123_09

29.01.2019

(Updated08.02.2019)

MicroVention Europe S.A.R.L.

HydroPearl microspheres 
Model: 8HP2S600;8HP2S600 
Lot: 17030434

MD: Embolization particle, non-bioabsorbable

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190122_02

07.02.2019

Medtronic Inc.

CareLink Encore Programmer 
Model: 29901 
S/N: All

CareLink Programmer 
Model: 2090 
S/N: all

AIMD: Cardiac pulse generator programmer

AIMD: Cardiac pulse generator programmer

FR-1.0 
IT-1.0 
EN-1.0 
EN-1.0 

Vk_20190121_18

09.10.2018

(Updated07.02.2019)

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 
DE-2 
FR-1 
FR-2 
IT-1 
IT-2 
EN-1 

Vk_20181009_03

05.02.2019

Bonalive Biomaterials Ltd

BonAlive putty MIS 
Model: 18100, 18131 
Lot: BM-03/18/9, BM-04/18/9

MD: Bone matrix implant, synthetic

FR-1 
EN-1 

Vk_20190204_11

05.02.2019

Swemac Innovation AB

Motec Wrist Radius Cup 
Model: 40-1015S 
Lot: 178733

MD: Total wrist prosthesis

EN-1 

Vk_20190130_14

25.01.2019

(Updated04.02.2019)

Medtronic Inc.

Adapta, Versa, Sensia, Relia, Attesta, Sphera and Vitatron A, E, G, Q series Implantable Pulse Generators 
Model: see FSN 
S/N: All manufactured between Jan-2017 and Jan-2019

AIMD: Dual-chamber implantable pacemaker, rate-responsive

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190118_04

23.01.2019

(Updated04.02.2019)

EDAP TMS FRANCE

SONOLITH I-SYS 
S/N: see FSN

MD: Lithotripsy system, external

DE-1 
EN-1 

Vk_20190117_13

23.01.2019

(Updated31.01.2019)

BioMérieux Inc.

VITEK 2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards 
Model: see FSN 
Lot: see FSN

IVD: Bacteriology – Identification & Susceptibility Testing

DE-1 
FR-1 
EN-1 

Vk_20190115_12

31.01.2019

Topcon Corporation

DRI OCT Triton 
S/N: See FSN

DRI OCT Triton plus 
S/N: See FSN

MD: Ophthalmic camera

MD: Ophthalmic camera

DE-1 
FR-1 
EN-1 

Vk_20190110_11

19.12.2017

(Updated31.01.2019)

Cardiac Pacemaker Inc

VALITUDE CRT-P 
Model: U125, U128

ALTRUA 2 Pacemaker 
Model: S701, S702, S722

ESSENTIO 
Model: L100, L101, L110, L111, L121, L131

ACCOLADE 
Model: L300, L301, L310, L311, L321, L331

PROPONENT 
Model: L200, L201, L209, L210, L211, L221, L231

VISIONIST CRT-P 
Model: U225, U226, U228

AIMD: Cardiac resynchronization therapy implantable pacemaker

AIMD: Dual-chamber implantable pacemaker, rate-responsive

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Single/Dual Chamber Pacemakers (rate responsive)

AIMD: Cardiac resynchronization therapy implantable pacemaker

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

Vk_20171213_14

20.12.2017

(Updated31.01.2019)

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

Vk_20171213_13

25.01.2019

(Updated30.01.2019)

Laboratoires Anios

WIP ANIOS PREMIUM, WIP ANIOS EXCEL 
Model: See FSN 
Lot: See FSN

MD: Medical device disinfection wipe

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190124_15

24.01.2019

(Updated30.01.2019)

DMD

DENTASEPT SH PRO WIPES 
Model: 6 packs of 100 wipes; 2477655EC 
Lot: See FSN

MD: Medical device disinfection wipe

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190124_03

29.01.2019

Cepheid

Xpert GBS 
Model: GXGBS-100N-10 
Lot: All

IVD: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190128_01

29.01.2019

Boston Scientific Corporation

Agile Biliary RX Fully Covered Stent System 
Model: M00586000, M00586010, M00586020, M00586060, M00586070, M00586080 
Lot: All

MD: Polymer-metal biliary stent

DE-1 
EN-1 

Vk_20190125_14

29.01.2019

GE Healthcare

Centricity Universal Viewer 
SW-Version: See FSN

MD: Medical image management system

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190122_08

23.01.2019

(Updated28.01.2019)

USF Healthcare

UNISEPTA FOAM 2 WIPES 
Model: 6 packs of 100 wipes; 2476655MC 
Lot: See FSN

MD: Medical device disinfection wipe

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190122_03

17.01.2019

(Updated28.01.2019)

ConvaTec Limited

Rectal Tubes 
Model: See FSN 
Lot: See FSN

Unoversal Drainage Systems 
Model: See FSN 
Lot: See FSN

SimpaVac 
Model: See FSN 
Lot: See FSN

Sterile Suction Connecting Tubes 
Model: See FSN 
Lot: See FSN

Sterile Connecting Pieces 
Model: See FSN 
Lot: See FSN

Suction Handles/Sets (FilterFlow/Deltaflo) 
Model: See FSN 
Lot: See FSN

Oxygen Catheters 
Model: See FSN 
Lot: See FSN

Sterile Nasal Oxygen Cannulas 
Model: See FSN 
Lot: See FSN

Sterile Oxygen Connecting Tubes 
Model: See FSN 
Lot: See FSN

Sterile Forceps 
Model: See FSN 
Lot: See FSN

MD: Colonic lavage nozzle, non-sterile, single-use

MD: Closed-wound drainage kit

MD: Closed-wound/centesis drainage receptacle

MD: Suction system tubing

MD: Closed-wound drain connector

MD: Basic suction tips for handles, General purpose suction system, vacuum for sets

MD: Oxygen administration nasal catheter

MD: Basic nasal oxygen cannula

MD: Oxygen administration tubing

MD: Soft-tissue surgical forceps, scissors-like, single-use

DE-1-Distributor 
DE-1-Endnutzer 
FR-1-Distributeurs
FR-1-Util. Finaux 
IT-1-Distributori 
IT-1-Utenti Finali 
EN-1-Distributor 
EN-1-End User 

Vk_20190115_02

22.01.2019

Edwards Lifesciences LLC

IntraClude Intra-Aortic Occlusion Device 
Model: ICF100 
Lot: All 
S/N: N/A

MD: Intravascular occluding catheter, image-guided

DE-1 
EN-1 

Vk_20190118_18

21.01.2019

Cook Incorporated

Sof-Flex Multi-Length Ureteral Stent Set 
Model: 039500-8-20 
Lot: See FSN

Roadrunner Hydrophilic PC Wire Guide 
Model: RFSPC-035145-0-I-AQ, RFSPC-038145-0-I-AQ 
Lot: See FSN

Percutaneous Pigtail Nephrostomy Set 
Model: 080008, 080010, 080012 
Lot: See FSN

Urethral Dilation Balloon Catheter with Open Tip 
Model: UDBS-070029-OW 
Lot: See FSN

PTFE Wire Guide 
Model: 635413-10, 638413-10, 638813 
Lot: See FSN

Percutaneous Entry Set 
Model: 080000 
Lot: See FSN

Bander Ureteral Diversion Open-End Stent Set 
Model: 025707-S1 
Lot: See FSN

MD: Polymeric ureteral stent

MD: General-purpose non-vascular guidewire

MD: Nephrostomy catheter

MD: Endoscopic-access dilator, single-use

MD: General-purpose non-vascular guidewire

MD: Suprapubic cannula/trocar, single-use

MD: Polymeric ureteral stent

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190115_11

18.01.2019

Philips Healthcare

Philips Efficia Monitors 
Model: The affected products are all Efficia CM Monitors manufactured before Oct 25, 2018 that are capable of operating under battery power and have lithium-ion batteries presently installed. Specifically, the following Efficia CM Monitors with software release 
S/N: See UAL86000259 
SW-Version: See Model Number section above

MD: Single-patient physiologic monitoring system

DE-1 
FR-1 
EN-1 

Vk_20190118_08

16.01.2019

Oxford Immunotec Ltd.

T-Cell Select 
Model: TSK.910 
Lot: 001, 002, 003, 006, 009 
SW-Version: N/A

IVD: Leukocyte magnetic separation kit IVD

DE-1 
EN-1 

Vk_20190110_06

15.01.2019

Ziehm Imaging GmbH

Ziehm Vision 
Model: RFD, RFD 3D

Ziehm Solo 
Model: FD

MD: Radiographic/fluoroscopic unit, general-purpose

MD: Radiographic/fluoroscopic unit, general-purpose

DE-1 
IT-1 

Vk_20190111_16

15.01.2019

GE ULTRASOUND Korea, Ltd

Senographe Crystal Nova

MD: Stationary mammographic x-ray system, digital

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190111_06

04.01.2019

(Updated15.01.2019)

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 
S/N: All

MD: Abdominal aorta endovascular stent-graft

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20190104_10

14.01.2019

Medtronic Xomed

NIM Eclipse System 
Model: NWCPUE4, NCCPUE4, NCCPU, NWCPU 
Lot: All

Single Use Direct Nerve Probes 
Model: BNP2001, BNP2002, CNP2001, CNP2002, FTP1001, MNP1001, PSP1000, PSP1001, PSP1002, FTP2001, MNP2001, PSP2000, PSP2001, PSP2002 
Lot: all

MD: Nerve-locating system, line-powered

MD: Single-use Stimulator Probes

DE-1 
FR-1 
EN-1 

Vk_20190114_04

09.01.2019

(Updated14.01.2019)

Thermofisher Scientific

Oxoid M.I.C.E Meropenem MA0121 
Lot: 2356765, 2341306

IVD: Meropenem minimum inhibitory concentration (MIC) IVD

DE-1 
FR-1 
EN-1 

Vk_20190108_07

09.01.2019

(Updated14.01.2019)

Wallac Oy

DELFIA / AutoDELFIA hCG Kit 
Model: A007-101, B007-101, B007-112 
Lot: 1066489101, 1066647101, 12066660401, 1099467001, 1066467002, 1066655301, 1066430301, 1066430302

DELFIA / AutoDELFIA hCG Kit 
Model: A082-101, B082-101 
Lot: 1066723301, 1066714001

IVD: Total human chorionic gonadotropin (HCG) IVD, kit, fluorescent immunoassay

IVD: Trisomy 21-risk hormone IVD, kit, fluorescent immunoassay

DE-1 
FR-1 
EN-1 

Vk_20190104_09

12.12.2018

(Updated14.01.2019)

Terumo BCT, Inc.

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

MD: Apheresis system

DE-1 
FR-1 
IT-1 

Vk_20181207_28

06.04.2018

(Updated14.01.2019)

Abbott – Thoratec Corporation

Heartmate III 
Model: 106524INT HM3 LVAS Kit 
S/N: All serial numbers

AIMD: Implantable ventricular circulatory assist system

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

Vk_20180406_18

11.01.2019

Edwards Lifesciences LLC

Swan Ganz Thermodilution Catheters 
Model: 131F7, 131F7P, 131VF7P and 151F7;131F7, 131F7P, 131VF7P and 151F7 
Lot: Model 131VF7P: 61176314 Model 151F7: 61176367 and 61176370 Model 131F7P: 61321241, 61176369, 61176373, 61176374, 61311580 and 61321254 (Model 131F7P is a specific packaging configuration for model 131F7). See Attachment 1 for Manufacturing and Expir 
SW-Version: N/A

MD: Pulmonary artery catheter, thermal dilution

FR-1 
EN-1 

Vk_20190108_03

27.12.2018

(Updated10.01.2019)

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 
FR-1 
EN-1 

Vk_20181221_09

28.12.2018

(Updated09.01.2019)

Zimmer GmbH

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

MD: Acetabular shell

DE-1 
FR-1 
IT-1 

Vk_20181228_10

27.12.2018

(Updated09.01.2019)

Balt Extrusion

ECLIPSE2L 
Model: ECL2L 6X20 
Lot: 00321583 and 00332661

MD: Intravascular occluding catheter, image-guided

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181227_17

04.01.2019

(Updated09.01.2019)

Unimed SA

UNIMED Medical Needle 
Model: See FSN

MD: Spinal needle, Anaesthesia needle

DE-1 
FR-1 
IT-1 
EN-1 

Vk_20181220_13

21.12.2018

(Updated09.01.2019)

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

FR-1 
EN-1 

Vk_20181211_12

27.11.2018

(Updated09.01.2019)

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

DE-1 
FR-1 
EN-1 

Vk_20181126_10

08.01.2019

Cook Incorporated

Entuit Secure Gastrointestinal Suture Anchor Set 
Model: GIAS-SRM-2, GIAS-SRM-3 
Lot: See FSN

MD: Gastrostomy T fastener

DE-1 
FR-1 
EN-1 

Vk_20190107_09

08.01.2019

TORNIER SAS

Osteosynthesis Plate XXS 
Model: PES100401, PES100501, PES100502, PES101801
Lot: All

Osteosynthesis Plate XS 
Model: PES120601, PES120501, PES120203, PES120202, PES120201, PE120601, PE120501, PE120203, PE120202, PE120201 
Lot: All

MD: Orthopaedic fixation plate, non-bioabsorbable, sterile

MD: Orthopaedic fixation plate, non-bioabsorbable, sterile

DE-1 
FR-1 
IT-1 

Vk_20190104_02

03.01.2019

(Updated08.01.2019)

Varian Oncology Systems (USA)

Eclipse Treatment Planning System 
Model: H48 
S/N: see FSN 
SW-Version: 13.0, 13.5, 13.6, 13.7, 15.1, 15.5 and 15.6

MD: Radiation therapy treatment planning system

DE-1-(13.x) 
DE-1-(15.x) 
FR-1-(13.x) 
FR-1-(15.x) 
EN-1-(13.x) 
EN-1-(15.x) 

Vk_20190103_0

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