Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2018 – 28.04.2018

Опубліковано 03.05.2018 о 00:00

Швейцарія

 

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

 

 

06.04.2018

 

(Updated04.05.2018)

 

Abbott – Thoratec Corporation

 

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

 

AIMD: Implantable ventricular circulatory assist system

 

DE-1 
FR-1 
EN-1 

 

Vk_20180406_18

 

03.05.2018

 

Vital Healthcare Sdn. Bhd.

 

Tubing Sets for Hemodialysis / NovaLine 
Model: See FSN 
Lot: All lots manufactured in year 2017: “2017XXXXXXXX”

 

MD: Hemodialysis Tubing Sets

 

FR-1 

 

Vk_20180425_05

 

25.04.2018

 

(Updated03.05.2018)

 

Alere Technologies AS

 

Alere Afinion ACR Control 
Model: 1116046 
Lot: 10193874; 10195699; 10195060

 

IVD: Microalbumin IVD, control

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180420_05

 

26.03.2018

 

(Updated03.05.2018)

 

Philips Medical Systems

 

Philips HS1 A 
Model: M5066A, M5067A, M5068A

 

Philips HeartStart FRx AED 
Model: 861304, 861305

 

MD: Non-rechargeable public automated external defibrillator

 

MD: Non-rechargeable public automated external defibrillator

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180319_02

 

02.05.2018

 

Samsung Electronics Co., Limited

 

GC80 
Model: GC80; DGR-C25U2J/US

 

MD: Stationary basic diagnostic x-ray system, digital

 

EN-1 

 

Vk_20180430_01

 

02.05.2018

 

Roche Diagnostics GmbH

 

MagNA Pure 24 System 
Model: 07290519001; 07613336106174 
Lot: n/a 
S/N: n/a

 

IVD: Nucleic acid sample preparation instrument IVD, automated

 

EN-1 

 

Vk_20180427_10

 

01.05.2018

 

B. Braun Melsungen AG

 

Askina Calgitrol Paste 
Model: 6241505 / 5547016 
Lot: all

 

Askina Gel 
Model: 001419S / 2159360 
Lot: all

 

MD: Cavity-wound management dressing, antimicrobial

 

MD: Cavity-wound management dressing, antimicrobial

 

DE-1 
FR-1 
IT-1 

 

Vk_20180423_14

 

25.04.2018

 

(Updated01.05.2018)

 

Roche Diagnostics GmbH

 

Combur-Test UX, Chemstrip 10 A 
Model: see FSN

 

Urisys 1100 
Model: see FSN

 

IVD: Urine rapid test device, multiple-constituent

 

IVD: Urine analyser IVD, laboratory, automated

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180420_08

 

30.04.2018

 

K2M Inc.

 

Cascadia Interbody System 
Model: See FSN 
Lot: See FSN

 

MD: Vertebral body prosthesis, sterile

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180423_08

 

25.04.2018

 

(Updated27.04.2018)

 

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 
FR-1 
EN-1 

 

Vk_20180418_01

 

23.04.2018

 

(Updated27.04.2018)

 

Intuitive Surgical, Inc

 

da Vinci Xi EndoWrist Stapler 45 Reload 
Model: Blue 48645B-03, Green 48445G-03 
Lot: M11160202 till L10180107, M10151014 and M11160601 till M11180221

 

MD: Surgical staple, non-bioabsorbable

 

DE-1 
FR-1 
EN-1 

 

Vk_20180416_01

 

19.04.2018

 

(Updated27.04.2018)

 

RaySearch Laboratories AB

 

RayStation 
Model: 6 (RayPlan 2), 7 (RayPlan 7)

 

MD: Radiation therapy software

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180409_06

 

27.04.2018

 

Cardiac Pacemakers, Inc, (Boston Scientific Corporation)

 

INGEVITY MRI 
Model: 7740, 7741, 7742

 

AIMD: Pacemaker/defibrillator lead

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20170928_11

 

26.04.2018

 

Konica Minolta Inc.

 

Fingerclip Sensor of PULSOX-300 Series 
Model: SR-5C (Art CH8196)

 

MD: Pulse oximeter probe, reusable

 

DE-1 
FR-1 

 

Vk_20180420_16

 

25.04.2018

 

(Updated26.04.2018)

 

Abbott

 

Implantable Cardioverter Defibrillators 
Model: See FSN

 

AIMD: Cardiac pulse generator software

 

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

 

Vk_20180418_07

 

26.04.2018

 

ConvaTec Limited

 

AbViser AutoValve Pressure Monitoring Device 
Model: ABV300, ABV301, ABV601 
Lot: All

 

: Intra-abdominal pressure measurement set, electronic

 

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

 

Vk_20180410_20

 

25.04.2018

 

Stryker Trauma Kiel

 

T2 Nailing System 
Model: see fsn

 

MD: Arthrodesis, Tibia and Femur nail, sterile

 

EN-1 

 

Vk_20180423_15

 

25.04.2018

 

Philips Medical Systems Nederland BV

 

Multidiagnost Eleva, MultiDiagnost Eleva with Flat Detector and UroDiagnost Eleva systems. 
Model: 708032, 708033, 708034, 708035, 708036, 708037, 708038

 

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

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180423_05

 

25.04.2018

 

ENDALIS

 

END BALL 
Model: END T110 
Lot: 17-0096

 

MD: Appetite-suppression gastric balloon

 

FR-1 

 

Vk_20180419_11

 

24.04.2018

 

IBL International GmbH

 

Progesterone Luminescence Immunoassay 
Model: RE62021_RE62029 
Lot: LPR145; LPR146; LPR147; LPR148

 

IVD: Progesterone kit

 

DE-1 
FR-1 

 

Vk_20180418_03

 

17.04.2018

 

(Updated23.04.2018)

 

Arrow International Inc.

 

Various Arrow Products 
Model: see FSN 
Lot: see FSN

 

MD: Products for Catheter navigation, Catheters, Catheter Accessories, Syringes and Needles, Surgical Drapes

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180413_07

 

13.04.2018

 

(Updated23.04.2018)

 

BD Switzerland Sàrl

 

Alaris SMARTSITE ADD-ON BAG ACCESS DEVICE 
Model: 10013365-0006 
Lot: 15055147, 15065148, 15065656, 15075252, 15075795, 15076168, 15085110, 15085157

 

MD: Fluid transfer set, general-purpose

 

DE-1 
EN-1 

 

Vk_20180410_10

 

27.03.2018

 

(Updated23.04.2018)

 

Ethicon Endo-Surgery, LLC

 

ENDOPATH XCEL Trocars with OPTIVIEW Technology 
Model: Product code: 2B5ST, 2B5LT, 2B5XT, 2CB5ST, 2CB5LT; Kit code: LSR278 
Lot: with expiration dates between September 2022 through January of 2023; Kit Lot Number: 10064703, 10064715, 10064728, 10064749

 

MD: Laparoscopic access cannula, single-use

 

DE-1 
FR-1 
EN-1 

 

Vk_20180323_15

 

23.04.2018

 

Synthes GmbH

 

Epoca Revision Set 
Model: 03.401.072 & 03.401.077 
Lot: For PN 03.401.072: 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949; For PN 03.401.077: 10-4566

 

MD: Orthopaedic implant inserter/extractor

 

DE-1 
EN-1 

 

Vk_20180320_01

 

11.04.2018

 

(Updated20.04.2018)

 

Becton, Dickinson and Company

 

BD Vacutainer EDTA tubes, BD Vacutainer Lithium Heparin tubes 
Model: See FSN 
Lot: All

 

IVD: Blood collection tube, evacuated

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180406_16

 

14.03.2018

 

(Updated20.04.2018)

 

Micro Therapeutics, Inc.

 

MindFrame Capture LP 
Model: 300010, 300011, 300012, 300013 
Lot: All

 

MD: Thrombectomy suction catheter

 

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

 

Vk_20180228_06

 

09.04.2018

 

(Updated19.04.2018)

 

Promedical AG

 

Yankauer Absaugrohr/TATA/Yankauer suction tube 
Model: TA-TAYT-10-203 
Lot: P-7424; P-7937; P-9866; P-12070; P-12202; P-12173; P-6850; P-7432 P-10438

 

MD: Cannulae, Aspirating

 

DE-1 
DE-2 

 

Vk_20180305_19

 

18.04.2018

 

Phadia AB

 

EliA Intrinsic Factor Well 
Model: 14-5668-01 
Lot: 0015

 

IVD: Intrinsic factor antibody IVD, kit, fluorescent immunoassay

 

DE-1 
FR-1 
EN-1 

 

Vk_20180416_17

 

18.04.2018

 

Nihon Kohden Corp.

 

Celltac G 
Model: MEK-9100 
S/N: see FSN 
SW-Version: < 01-15

 

IVD: Haematology analyser, cell differential

 

DE-1 
EN-1 

 

Vk_20180413_23

 

18.04.2018

 

Philips Healthcare (Suzhou) Co.Ltd

 

T5, T10-NT, ACSNT, Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T, Ingenia CX 1.5T and Panorama 1.0T systems

 

MD: Full-body MRI system, superconducting magnet

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180412_05

 

18.04.2018

 

Siemens Healthcare Diagnostics Inc.

 

ADVIA Chemistry Systems Urea Nitrogen (UN) Reagent 
Model: 10309051 
Lot: 408143, 418290

 

IVD: Blood Urea Nitrogen (BUN) IVD, kit, enzyme spectrophotometry

 

DE-1 
EN-1 

 

Vk_20180412_02

 

17.04.2018

 

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

 

Logiq 9, Logiq E9

 

MD: General ultrasound imaging system, line-powered

 

DE-1 
FR-1 
IT-1 

 

Vk_20180417_05

 

17.04.2018

 

Zimmer, Inc.

 

Segmental System Proximal Femoral Component 
Model: 38mm 
Lot: See FSN (Attachment 2)

 

MD: Revision uncoated hip femur prosthesis

 

FR-1 
EN-1 

 

Vk_20180416_08

 

17.04.2018

 

Covidien LLC

 

EEA Hemorrhoid and Prolapse Stapler Set with DST 
Model: HEM3335, HEM3348 
Lot: Refer to table in FSN

 

MD: Haemorrhoidal surgical stapler, single-use

 

DE-1 
EN-1 

 

Vk_20180416_05

 

17.04.2018

 

Genicon

 

EZee Retrieval 
Model: 550-000-000 
Lot: I8095/2017-11-08, I8162/2018-01-09, I8162/2020-01-09

 

MD: Tissue extraction bag

 

EN-1 

 

Vk_20180416_04

 

17.04.2018

 

Zimmer, Inc.

 

ZNN and M/DN Guide Wires 
Lot: See FSN (Attachment 2)

 

MD: Orthopaedic prosthesis implantation instrument (reusable and single-use); Orthopaedic bone wire

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180411_06

 

17.04.2018

 

LAP GmbH Laser Applikationen

 

APOLLOblue (24V) 
Model: APOLLOblue laser systems delivered with a FW7660M/24 power supply plug of the series GPP10 by FRIWO Gerätebau GmbH manufactured from calendar week 50/2013 to calendar week 23/2014 
Lot: 4513O, 4613O, 4713O, 4813O, 5113O, 5213O, 0114O, 0214O, 0314O, 0414O, 0514O, 0614O, 0714O, 0814O, 0914O, 1014O, 1114O, 1214O, 1314O, 1414O, 1514O, 1614O, 1714O, 1814O, 1914O, 2014O, 2114O, 2214O, 2314O 
S/N: AP-KB: SN0011418, SN0011417, AP-LB: SN0004621

 

MD: Laser Beam Imaging Media

 

DE-1 
EN-1 

 

Vk_20180410_21

 

17.04.2018

 

Tornier, Inc.

 

Aequalis Humerail Nail Drill Bit Sterile 
Model: 7020140 
Lot: see FSN

 

MD: Orthopaedic prosthesis implantation instrument, single-use

 

DE-1 
FR-1 
IT-1 

 

Vk_20180410_12

 

17.04.2018

 

Hepro AS

 

Sister assistance for Gripo 
Model: 35148 
S/N: hanging grip sold / delivered from Hepro in the period 1.8.2017 – 15.1.2018

 

MD: Hanging grip

 

EN-1 

 

Vk_20180410_11

 

17.04.2018

 

GE Vingmed Ultrasound AS

 

Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, Vivid E95

 

MD: Cardiovascular ultrasound imaging system

 

DE-1 
FR-1 
IT-1 

 

Vk_20180410_06

 

11.04.2018

 

(Updated17.04.2018)

 

Becton, Dickinson and Company

 

BD Vacutainer Plus Citrate tube 
Model: 363048 
Lot: 7298982

 

IVD: Evacuated blood collection tube IVD, sodium citrate

 

DE-1 
FR-1 
EN-1 

 

Vk_20180404_03

 

04.04.2018

 

(Updated17.04.2018)

 

Medical Econet GmbH

 

Cardio M and Cardio M Plus 
S/N: All Cardio M (all serial numbers), Cardio M plus from production start in 2009 Serial number T2…. up to and including serial number starting with T7….

 

MD: Electrocardiographic monitor

 

FR-1.0 
IT-1.0 
EN-1.0 

 

Vk_20180221_05

 

16.04.2018

 

Schiller AG

 

Cardiovit AT-102 plus 
Model: 0.075000 
S/N: All

 

MD: Multichannel electrocardiograph, interpretive, professional

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180403_20

 

28.03.2018

 

(Updated16.04.2018)

 

Alere Technologies AS

 

Alere Afinion 2 
Model: 1116553, 1116556, 1116557 
S/N: From AF20000001 to AF20002298 
SW-Version: 20.00, 20.01, 20.04, 20.06, 21.00

 

IVD: Single-channel clinical chemistry analyser IVD, point-of-care

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180326_10

 

16.03.2018

 

(Updated16.04.2018)

 

CIVCO Medical Instruments CO

 

Infiniti Bracket (Sold as part of CIVCO brand Biopsy Starter Kits and Biopsy Bracket) 
Model: 639-026, 698-009, 698-016, 620-116 
Lot: See FSN

 

MD: Nonimplantable needle guide, single-use

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180308_01

 

12.04.2018

 

(Updated13.04.2018)

 

MRC Holland BV

 

SALSA MLPA Probemix P060 SMA 
Model: P060-025R 
Lot: B2-1116 
SW-Version: 140721.1958

 

IVD:

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180403_09

 

03.04.2018

 

(Updated13.04.2018)

 

Synthes GmbH

 

Sciatic Nerve Retractor 
Model: 03.100.013 and 03.100.014 
Lot: See FSN

 

MD: Orthopaedic retractor

 

DE-1 
EN-1 

 

Vk_20180403_04

 

29.03.2018

 

(Updated13.04.2018)

 

DiaMed GmbH

 

ID LISS/Coombs ID number 50531 
Model: see FSN 
Lot: see FSN

 

ID Coombs Anti-IgG ID number 50540 
Model: see FSN 
Lot: see FSN

 

ID DiaScreen ID number 50571 
Model: see FSN 
Lot: see FSN

 

ID LISS/Coombs + Enzyme test ID number 50581 
Model: see FSN 
Lot: see FSN

 

ID DiaClon Type + Screen (ID-Nr.: 50682) 
Model: see FSN 
Lot: see FSN

 

IVD: Polyspecific antihuman serum

 

IVD: Polyspecific antihuman serum kit

 

IVD: Polyspecific antihuman serum

 

IVD: Polyspecific antihuman serum

 

IVD: ABO sera

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180327_01

 

28.03.2018

 

(Updated13.04.2018)

 

Getinge – Maquet GmbH

 

Otesus 
Model: 116001C0, 116001D0 
S/N: 116001C0: 1 until 552, 116001D0: 1 until 34

 

MD: Table, operating

 

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

 

Vk_20180315_02

 

04.04.2018

 

(Updated12.04.2018)

 

Arcoma AB

 

Intuition 
Model: 0180 
S/N: 1100 – 2036

 

Precision 
Model: 0072 
S/N: 1001 – 2105

 

MD: Stationary basic diagnostic x-ray system, digital

 

MD: Stationary basic diagnostic x-ray system, digital

 

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

 

Vk_20180403_16

 

19.03.2018

 

(Updated12.04.2018)

 

ArjoHuntleigh AB

 

Entroy 
Model: GAB1000-01 and GAB1000-11 
Lot: n/a 
S/N: From 810000957 up to T3387

 

MD: Mobile patient lifting system, battery-powered

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180312_12

 

11.04.2018

 

Siemens Healthcare Diagnostics Products GmbH

 

Atellica COAG 360 
Model: SMN 10707173 and 100759658 
SW-Version: SW V1.1.1 and below

 

IVD: Haematology analyser, coagulation

 

DE-1 
EN-1 

 

Vk_20180405_06

 

10.04.2018

 

Siemens Healthcare GmbH

 

SOMATOM go.Up and SOMATOM go.Now 
Model: 11061620, 11061610

 

MD: Full-body CT system

 

DE-1 
FR-1 

 

Vk_20180409_08

 

10.04.2018

 

Bio-Rad France

 

Mueller Hinton 2 Agar 
Model: 63824 
Lot: 64153869

 

IVD: Culture media, antimicrobial susceptibility test

 

DE-1 
EN-1 

 

Vk_20180405_12

 

10.04.2018

 

GE Healthcare Integrated IT Solutions

 

Lunar Prodigy 
SW-Version: 9.30

 

MD: Bone absorptiometric x-ray system, dual-energy

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180403_37

 

28.03.2018

 

(Updated10.04.2018)

 

Stryker Medical Kalamazoo

 

POWER LOAD 
Model: 6390 
Lot: Units manufactured from 01.01.2016 to 31.12.2016

 

MD: Ambulance stretcher, manual

 

DE-1 
EN-1 

 

Vk_20180319_10

 

28.03.2018

 

(Updated09.04.2018)

 

BioFire Diagnostics, LLC

 

FilmArray Blood Culture Identification (BCID) Panel 
Model: 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_20180326_11

 

27.03.2018

 

(Updated09.04.2018)

 

Covidien LLC

 

LigaSure Exact Dissector, Nano-coated 20.6mm-21c 
Model: LF2019 
Lot: 72550127X, 72770140X, 72770141X, 73000048X

 

MD: Dissector

 

DE-1 
FR-1 
EN-1 

 

Vk_20180326_08

 

28.03.2018

 

(Updated09.04.2018)

 

Hitachi High Technologies Corporation (HHT)

 

cobas 8000

 

cobas e 801 module 
S/N: from 1601-01 to 18E6-10

 

IVD: Multi-modality clinical specimen analysis system IVD

 

IVD: Chemiluminescent immunoassay analyser IVD, automated

 

DE-1 
FR-1 
EN-1 

 

Vk_20180323_14

 

28.03.2018

 

(Updated09.04.2018)

 

Dako Denmark A/S

 

Monoclonal Mouse Anti-Pneumocystis Jiroveci 
Model: M0778 
Lot: 20010445, 20030858, 20042555

 

Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell 
Model: M0880 
Lot: 20033445, 20040767, 20042272

 

IVD: Pneumocystis jirovecii antigen IVD, antibody

 

IVD: Hairy cell leukaemia (HCL) cell marker IVD, antibody

 

DE-1 
FR-1 
EN-1 

 

Vk_20180323_12

 

20.03.2018

 

(Updated05.04.2018)

 

Implant Direct Sybron Manufacturing LLC

 

simply InterActive Implant 
Model: 655010U 
Lot: 68960

 

MD: Dental implant system

 

DE-1 
FR-1 
EN-1 

 

Vk_20180316_09

 

20.03.2018

 

(Updated05.04.2018)

 

Implant Direct Sybron Manufacturing LLC

 

InterActive Healing Collar 
Model: 6530-15 
Lot: 98151

 

MD: Dental implant suprastructure, permanent

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180316_08

 

23.10.2017

 

(Updated05.04.2018)

 

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 
FR-1 
FR-2 
FR-3 
IT-2 
IT-3 

 

Vk_20171010_11

 

04.04.2018

 

Iris Diagnostics, a Division of Iris International

 

iChemVELOCITY Automated Urine Chemistry System 
Model: 800-3530, 800-7167, 800-7719, 800-7720, 800-7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700-7176-001, 700-7177-001 
S/N: All

 

IVD: Urine analyser IVD, laboratory, automated

 

EN-1 

 

Vk_20180403_25

 

04.04.2018

 

Siemens Healthcare Diagnostics Inc

 

CTNI Sample Diluent 
Model: KD692 
S/N: 7BDA34

 

Multi 1 Sample Diluent (MULTI 1 SDIL) 
Model: KD693 
S/N: 7BDA81

 

Multi 2 Sample Diluent (MULTI 2 SDIL) 
Model: KD694 
S/N: 7CDA79, 7DDA70

 

IVD: Buffered sample diluent IVD, automated/semi-automated system

 

IVD: Buffered sample diluent IVD, automated/semi-automated system

 

IVD: Buffered sample diluent IVD, automated/semi-automated system

 

DE-1.0 
FR-1.0 

 

Vk_20180403_17

 

04.04.2018

 

arcomed ag

 

Volumed µVP7000

 

MD: Infusion Pumps, Multitherapy, Ambulatory

 

DE-1.service tech. 
DE-1.user 
FR-1.service tech. 
FR-1.user 
EN-1.service tech. 
EN-1.user 

 

Vk_20180316_18

 

03.04.2018

 

Philips Medical Systems Nederland BV

 

Allura Xper 
SW-Version: 8.1.25.0, 8.1.25.1, 8.1.25.5, 8.2.25.0, 8.2.25.5, 8.2.27

 

UNIQ 
SW-Version: 1.0.10, 1.0.10.5

 

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_20180403_23

 

03.04.2018

 

Kimal Plc

 

Altius Central Venous Catheter Kit 
Model: See FSN 
Lot: See FSN

 

MD: Central Venous Catheter Kit

 

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

 

Vk_20180327_14

 

03.04.2018

 

Medline International France SAS

 

LDH-Set 
Model: ZGZNE004G 
Lot: 751533, 755464

 

Craniotomie Set 
Model: ZGZNE005H 
Lot: 755464

 

Augen-Set 
Model: ZGZEY034C 
Lot: 752319

 

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

 

:

 

:

 

DE-1.0 

 

Vk_20180323_09

 

03.04.2018

 

Proxomed Medizintechnik GmbH

 

compass 600 
Model: 1061190

 

MD: Exercisers, Continuous Passive Motion

 

DE-1 

 

Vk_20180319_12

 

29.03.2018

 

Mölnlicke Health Care AB

 

Pack Pied-Main 
Model: 97052006-03 
Lot: 18054178

 

Pack Rachis 
Model: 97083670-01 
Lot: 18037623

 

Mölnlycke Procedure trays: Pack cardiaque 
Model: 97010887-15 
Lot: 18057077

 

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

 

MD: Neurosurgical procedure kit, non-medicated, single-use

 

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

 

FR-1.0 

 

Vk_20180322_01

 

20.03.2018

 

(Updated29.03.2018)

 

GE Vingmed Ultrasound AS

 

TEE Probes 
Model: see FSN

 

MD: Oesophageal ultrasound imaging system transducer, reusable

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180316_17

 

29.03.2018

 

Philips Consumer Lifestyle B.V.

 

AVENT Smart Ear Thermometer and Ear thermometer 
Model: SCH740, DL8740 
S/N: All manufactured devices 
SW-Version: All software versions

 

MD: Infrared patient thermometer, ear

 

DE-1 
FR-1 
IT-1 

 

Vk_20180314_11

 

28.03.2018

 

ACUTRONIC Medical Systems AG

 

fabian Therapy evolution 
Model: 121001 
S/N: between AT10HA-0001 and AT11AC-0254

 

MD: Neonatal intensive-care ventilator

 

DE-1.0 
FR-1.0 
IT-1.0 
EN-1.0 

 

Vk_20180309_11

 

27.03.2018

 

Cook Urological, Inc.

 

StoneBreaker Pneumatic Lithotripter 
Model: Refer to product listing attached 
Lot: All lots of SBL-KIT1, SBA-EC, SBA-EL, SBA-PC, SBA-SC; All unexpired lots of SBC-10, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-02042 
SW-Version: LCK1.6

 

MD: Hand pneumatic lithotripsy system, urinary

 

DE-1.0 
FR-1.0 
EN-1.0 

 

Vk_20180326_12

 

27.03.2018

 

Draeger Medical Systems, Inc.

 

Infinity Acute Care System 
Model: M540 
SW-Version: VG2.2 to VG4.1

 

MD: Single-patient physiologic monitoring system

 

DE-1 
FR-1 
IT-1 

 

Vk_20180322_08

 

20.03.2018

 

(Updated26.03.2018)

 

Biotronik AG

 

Pulsar-18 
Model: 377493, 377476, 377486, 366820, 366816, 366818, 366834, 366843,366828, 377486 
Lot: 12173610, 12174145, 12174146, 12174363, 01180140, 01180366, 01180381, 01180465, 01181147, 01181148, 01182456, 01182837

 

MD: Multiple peripheral artery stent, bare-metal

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180314_10

 

26.03.2018

 

Implant Direct Sybron Manufacturing LLC

 

Spectra-System/Legacy Guided Surgery Handle Kit 
Model: G-HK 
Lot: 38665

 

MD: Surgical drill guide, reusable

 

DE-1 
FR-1 
IT-1 

 

Vk_20180314_04

 

26.03.2018

 

Gambro Dialysatoren GmbH

 

Ultrafilter U9000 
Model: 112062 
Lot: From 6-1907-H-01 and higher

 

MD: Microbial water purification filter, sterilizable

 

DE-1.0 

 

Vk_20180314_01

 

06.03.2018

 

(Updated23.03.2018)

 

F-Care Systems NV

 

HPR45i 
Lot: All

 

MD: Probe

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180130_15

 

20.03.2018

 

(Updated22.03.2018)

 

Becton, Dickinson and Company

 

BD Vacutainer Push Button Blood Collection Set 
Model: 367342 
Lot: see FSN 
S/N: N/A 
SW-Version: N/A

 

MD: Blood collection/intravenous fluid administration set

 

DE-1 
EN-1 

 

Vk_20180320_10

 

14.03.2018

 

(Updated22.03.2018)

 

DiaSys Diagnostic Systems GmbH

 

HbA1c FS 
Model: 1 3329… 
Lot: see FSN

 

IVD: Glycosylated/Glycated Haemoglobin

 

DE-1 
EN-1 

 

Vk_20180312_14

 

21.03.2018

 

IRIS International

 

iQ200 Series Urine Microscopy Analyzer 
Model: 700-3345, 700-3375, 700-3325, 700-3347, C10683, C10684 
Lot: N/A 
S/N: All 
SW-Version: Not Applicable

 

IVD: Urine analyser IVD, laboratory, automated

 

DE-1 
FR-1 
EN-1 

 

Vk_20180316_25

 

21.03.2018

 

bioMérieux

 

VIDAS FSH 
Model: 30407 / 30407-01 
Lot: 1005888210, 1005888220, 1006006370, 1006080890, 1006094700, 1006214640

 

IVD: Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)

 

DE-1 
FR-1 
EN-1 

 

Vk_20180315_09

 

21.03.2018

 

Siemens Healthcare Diagnostics Products GmbH

 

Atellica COAG 360 
Model: SMN 10707173 and 100759658 
Lot: n/a 
SW-Version: SW V1.1.2 and below

 

IVD: Haematology analyser, coagulation

 

DE-1 
EN-1 

 

Vk_20180314_14

 

06.03.2018

 

(Updated21.03.2018)

 

Eurogine

 

Intrauterine Device IUD Eurogine 
Lot: See FSN

 

MD: Intrauterine device, metal-covered

 

DE-2 
FR-2 
IT-2 
EN-1 
EN-2 

 

Vk_20180227_10

 

20.03.2018

 

Bentley InnoMed GmbH

 

BeGraft Peripheral Stent Graft System 
Model: 1) BGP5709_1; 2) BGP5709_2 
Lot: 1) 200713, 200675; 2) 200676, 200753, 200635 200546

 

MD: Stents, Vascular

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180320_02

 

20.03.2018

 

GE Healthcare Integrated IT Solutions

 

GE Centricity PACS IW 
SW-Version: 3.6.0 through 3.7.3.9

 

MD: Radiology picture archiving and communication system application software

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180315_18

 

20.03.2018

 

Micrel Medical Devices SA

 

Rythmic Evolution 
S/N: Less than (and including) 174611237019 
SW-Version: 1.4-A or earlier

 

MD: Patient-controlled analgesia infusion pump

 

DE-1 
FR-1 
EN-1 

 

Vk_20180312_09

 

31.07.2017

 

(Updated20.03.2018)

 

Becton, Dickinson & Company

 

UVE Specimen collection kit 
Model: 443376

 

BD MAX Vaginal Panel 
Model: 443710 ; 443712 
S/N: NA 
SW-Version: NA

 

BD MAX CT/GC 
Model: 442969

 

BD MAX CT/GC/TV 
Model: 442970

 

IVD: Urogenital specimen transport medium collection kit

 

IVD: Multiple vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)

 

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

 

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

 

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

 

Vk_20170721_03

 

19.03.2018

 

William A. Cook Australia Pty Ltd

 

Vacuum Pump 
Model: K-MAR-5200 
Lot: All lots

 

MD: General-purpose suction system, line-powered

 

DE-1 
FR-1 
IT-1 

 

Vk_20180319_04

 

19.03.2018

 

Applimed SA

 

Cannula needle 
Model: 8001727 
Lot: 17.11.08

 

MD: Cannulae

 

FR-1.0 
FR-2.0 
EN-1.0 
EN-2.0 

 

Vk_20180308_05

 

19.03.2018

 

HEINE Optotechnik GmbH & Co. KG

 

F.O. SP Laryngoskopgriff 
Model: F-001.22.815

 

MD: Laryngoscope handle, reusable

 

FR-1 
IT-1 
EN-1 

 

Vk_20180301_06

 

19.03.2018

 

Soluscope SAS

 

SOLUSCOPE SERIE 3 
Model: 4289, SL-V3-PA 
S/N: 23571, 23575

 

SOLUSCOPE SERIE 4 PA 
Model: 4102, SL-V4-PA 
S/N: 23191, 23329, 23982, 23983

 

MD: Flexible endoscope washer

 

MD: Flexible endoscope washer

 

DE-1 
FR-1 
IT-1 

 

Vk_20180221_01

 

16.03.2018

 

Mathys AG Bettlach

 

balanSys ligament tensor 
Model: 71.02.3018 
Lot: 2205708, 2205708N01, 2205708N02 
S/N: N/A

 

MD: Ligament tensor

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180308_13

 

16.03.2018

 

Biomet Orthopaedics, LLC

 

Persona Partial Knee Spacer Blocks 
Model: 42-5399-035-08, 42-5399-035-09, 42-5399-035-10, 42-5399-035-12, 42-5399-035-14 
Lot: 63552644, 63579568, 63547276, 63579569, 63610265, 63549084, 63579674, 63594433, 63610266. 63549096, 63579676, 63594434, 63610267 63549097, 63579680, 63596547, 63613101

 

MD: Orthopaedic prosthesis implantation instrument, reusable

 

DE-1.0 
FR-1.0 

 

Vk_20180306_10

 

15.02.2018

 

(Updated16.03.2018)

 

XO CARE A/S

 

Dental unit XO 
Model: XO, XO 4, XO FLEX

 

MD: Dental delivery system

 

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

 

Vk_20180130_03

 

15.03.2018

 

DiaMed GmbH

 

IH-1000 
Model: 001000 
Lot: NA 
S/N: NA 
SW-Version: 04.07.02

 

IVD: Blood grouping system, automated

 

DE-1 
EN-1 

 

Vk_20180312_02

 

07.03.2018

 

(Updated15.03.2018)

 

bioMérieux SA

 

VIDAS LH 
Model: 30406 
Lot: 1005940920, 1006041520, 1006041540, 1006212740, 1006274770

 

IVD: Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)

 

DE-1 
FR-1 
EN-1 

 

Vk_20180305_10

 

15.03.2018

 

Micro-Mega SA

 

B5 shape TS1 n25 4% L31 Classic sterile 
Model: 20953021 
Lot: 062117

 

MD: Rotary endodontic rasp, reusable

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180302_12

 

13.03.2018

 

(Updated14.03.2018)

 

Cryolife, Inc.

 

On-X Prosthetic heart valve 
Model: ONXA, ONXAE, ONXAC, ONXACE, ONXM, ONXMC, ONXAN 
Lot: all

 

MD: Cardiac valve prosthesis

 

DE-1 
FR-1 
EN-1 

 

Vk_20180312_03

 

14.03.2018

 

Philips Medical Systems (Cleveland) Inc.

 

Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128 
Model: 728317, 728326, 728325, 728321, 728323, 728324, 728306, 728311, 728243, 728244, 728246, 728240, 728235, 728231, 728332, 728256, 728251, 728241 
S/N: Refer to Units Affected List (UAL)

 

Brilliance CT 6, 10, 16, 16 Power, 40, 64, Big Bore Radiology, Big Bore Oncology, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Flex, MX8000 Dual v. EXP.

 

MD: Full-body CT system

 

MD: Full-body CT system

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180309_12

 

14.03.2018

 

Sofradim Production

 

Versatex Monofilament Mesh 50 x 50 cm 
Model: VTX5050M

 

MD: Abdominal hernia surgical mesh, synthetic polymer

 

FR-1 
EN-1 

 

Vk_20180308_08

 

14.03.2018

 

Randox Laboratories Ltd

 

Lipase 
Model: Ll3837, Ll7979, Ll8050, Ll8361 
Lot: Not batch specific

 

IVD: Lipase IVD, kit, enzyme spectrophotometry

 

FR-1 
IT-1 
EN-1 

 

Vk_20180306_09

 

06.03.2018

 

(Updated14.03.2018)

 

Hill-Rom, Inc.

 

PROGRESSA BED SYSTEM 
Model: P7500A 
Lot: Produced between June 8, 2017 to November 1, 2017 
S/N: S159AW9192 through S305AW2321

 

MD: Basic electric hospital bed

 

DE-1 
FR-1 
EN-1 

 

Vk_20180227_18

 

13.12.2017

 

(Updated14.03.2018)

 

DiaSys Diagnostic Systems GmbH

 

HbA1c IS 
Model: 1 3329 _ _ 
Lot: see FSN

 

HbA1c FS 
Model: 1 3329 _ _ 
Lot: see FSN

 

IVD: Glycosylated/Glycated Haemoglobin

 

IVD: Glycosylated/Glycated Haemoglobin

 

DE-1 
EN-1 
EN-2 (FS) 
EN-2 (IS) 

 

Vk_20171206_10

 

13.03.2018

 

Nobel Biocare AB

 

17° Multi-Unit Abutment CC NP 
Model: 36614;36614 
Lot: 12070802 
S/N: N/A 
SW-Version: N/A

 

MD: Dental implant suprastructure, permanent

 

DE-1 
FR-1 
IT-1 

 

Vk_20180313_01

 

12.03.2018

 

Bühlmann Laboratories AG

 

IBDoc, component: CalApp Reader (software) 
Model: LF-IBDOC8 
SW-Version: 1.5.06 (iOS) / 1.5.07 (Android) and earlier

 

IVD: Other Other Specific Proteins

 

DE-1 
FR-1 
EN-1 

 

Vk_20180302_04

 

20.02.2018

 

(Updated12.03.2018)

 

PACIFIC MEDICO

 

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

 

MD: Humidifier, heat/moisture exchange

 

DE-1 
FR-1 
IT-1 
EN-1 

 

Vk_20180115_03

 

20.12.2017

 

(Updated09.03.2018)

 

Biomet Orthopaedics, LLC

 

Persona Partial Knee Spacer Blocks 
Model: 42-5399-035-08, 42-5399-035-09, 42-5399-035-10, 42-5399-035-12, 42-5399-035-14 
Lot: 63767442, 63807190, 63769804, 63769805, 63769806, 63767443, 63813674

 

MD: Orthopaedic prosthesis implantation instrument, reusable

 

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

 

Vk_20171213_09

 

11.09.2017

 

(Updated09.03.2018)

 

Beckman Coulter Ireland, Inc.

 

AQUIOS CL Cytometer 
Model: B30166 
S/N: All

 

IVD: Flow cytometry analyser IVD, semi-automated

 

DE-1 
DE-2 
FR-1 
FR-2 
EN-1 
EN-2 

 

Vk_20170831_12

 

08.03.2018

 

Zimmer GmbH

 

Avenir Muller Stem 
Model: Size 4, Lateral: 01.06010.104 & Size 3, Standard: 01.06010.003 
Lot: 2905496; 2904368

 

MD: Coated hip femur prosthesis, modular

 

DE-1 

 

Vk_20180307_12

 

07.03.2018

 

Thermo Fisher Scientific Microbiology Basingstoke

 

Thermo Scientific Oxoid Brilliance Salmonella Agar Base
Model: CM1092B&T 
Lot: 2113980, 2113981, 2114481, 2125747, 2125748

 

IVD: Salmonella Agar

 

DE-1 
EN-1 

 

Vk_20180301_12

 

01.03.2018

 

(Updated07.03.2018)

 

bioMerieux Inc

 

VITEK 2 Compact 15/30 Systems 
Model: 27415, 27415R, 27530, 27530R, 27630, 27630R 
SW-Version: 8.01 version

 

IVD: Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

 

DE-1 
FR-1 
EN-1 

 

Vk_20180226_03

 

 

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