Field Safety Notices - 27 February - 3 March 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 27 February - 3 March 2017

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

1stQ: Acrylic IOL, AddOn, Spherical, hydrophilic, clear

17 February 2017

Implants, non-active, intraocular

Model: A4SW00

MHRA reference: 2017/002/027/291/024

AAP: VarioLoc cemented hip prosthesis, VarioLoc cementless hip prosthesis

25 February 2017

Joint prosthesis, hip

Model: all

MHRA reference: 2017/002/028/291/009

Accuscience: Adson Disposable Bipolar Forceps 110mm straight with 1mm tip, McPherson Disposable Bipolar Forceps 110mm Straight with Straight O.5mm tip, 110mm Straight Micro Jeweller with Straight 0.5mm tip, Disposable Bipolar Forceps 200mm Straight with 1mm Tip

20 January 2017

Surgical, diathermy

MHRA reference: 2017/002/024/291/024

Alere: Alere Afinion™ Lipid Panel Control

February-March 2017

IVDs, clinical chemistry

Model: Not applicable

MHRA reference: 2017/003/001/701/005

Arrow International: ARROW® PICC Kits with Peel-Away Sheath Component.

24 February 2017

Vascular cannula and catheters

Model: ARROW ® PICC

MHRA reference: 2017/002/027/291/006

Barco: MDRC-1119 Protective Front Cover

28 February 2017

Endoscopes, televisual systems

Model: C9826109

MHRA reference: 2017/002/028/701/012

Becton Dickinson: BD Preset™ Eclipse™ ABG device

13 January 2017

Storage and collection devices

MHRA reference: 2017/001/009/701/018

bioMérieux: VITEK® MS Instrument

24 February 2017

IVDs, bacteriology

Model: VITEK® MS Instrument, VITEK MS instrument for Japan

MHRA reference: 2017/002/024/291/016

Boston Scientific: Lotus™ Valve System

23 February 2017

Implants, non-active, cardiovascular heart valves

Model: H749LTV230, H749LTV250, H749LTV270

MHRA reference: 2017/002/023/291/004

Coloplast: Multi-organ procurement catheter

24 February 2017

Vascular cannula and catheters

Model: Multi-organ procurement catheter

MHRA reference: 2017/002/024/701/015

Fresenius Medical Care: multiFiltratePRO

22 February 2017

Dialysis, haemofilters

Model: multiFiltratePRO; M20 5001

MHRA reference: 2017/002/023/701/016

Hitachi: cobas® 8100 automated workflow series (cobas 8100 BRF and URF)

20 February 2017

IVDs, clinical chemistry

Model: 07439954001; 07441657001

MHRA reference: 2017/002/023/701/010

Hitachi: cobas 8000 modular analyzer series

22 February 2017

IVDs, clinical chemistry Model: cobas 8000 modular analyzer series: - cobas e 602 module (Model No. 05990378001) - cobas e 801 module (Model No. 07682913001)

MHRA reference: 2017/002/027/291/016

Immucor: Panocell®-20

20 February 2017

IVDs, blood transfusion MHRA reference: 2017/003/001/291/019

Invivo: Flex Cardio Patient Monitoring System

December 2016

Monitors, patient

Model: 453564243591 XPer Flex Cardio 2010, 453564241901 XPer Flex Cardio 2010-Exchange

MHRA reference: 2016/012/021/291/016

Medtronic: Endurant™ / Endurant II ™ Bifurcated Stent Graft Systems

March 2017

Implants, non-active, endoprostheses for aortic aneurysm Model: Various 23mm and 25mm mode

MHRA reference: 2017/003/001/291/026

Medtronic: HeartWare Ventricular Assist System

1 March 2017

Implantable ventricular assist devices Model: 1400, 1401 and 1407

MHRA reference: 2017/003/002/291/005

Nobel Biocare: Multi-unit abutment Plus CC RP 2.5mm

1 March 2017

Implants, dental

Model: 38882

MHRA reference: 2017/002/027/291/014

Philips: V60 Ventilator

8 February 2017

Lung ventilators

Model: V60

MHRA reference: 2017/003/001/291/006

Philips: BrightView SPECT, BrightView XCT, BrightView X 3/4 (Upgrade), BrightView X 3/8

23 February 2017

Nuclear medicine, PET-CT

MHRA reference: 2017/003/001/291/015

Respironics California: V60 Ventilator

2 February 2017

Lung ventilators

Model: V60

MHRA reference: 2017/002/028/291/010

Roche: Accu-Chek Insight

SB_RDC_2015_04

Infusion systems

Model: Accu-Chek Insight; 00700006889

MHRA reference: 2017/003/001/291/005

Siemens: ADVIA® Chemistry Enzyme 2 Calibrator

February 2017

IVDs, clinical chemistry

MHRA reference: 2017/002/024/601/004

Siemens: All artis systems with wireless foot switch

10 February 2017

X Ray, fluoroscopy systems

Model: 4787797, 4787805, 4787813

MHRA reference: 2017/002/027/601/001

Siemens: Artis Q / Q.zen

9 February 2017

X Ray, fluoroscopy systems

Model: Artis Q systems with A100G generators

MHRA reference: 2017/002/027/601/004

St. Jude Medical: Nanostim Leadless Cardiac Pacemaker (LCP) system

SJM Pre-Notification of Field Action Implants, active, pacemakers Model: Nanostim Leadless Cardiac Pacemaker (LCP) system MHRA reference: 2016/010/027/291/016

Thermo Fisher Scientific: Parallel or Perpendicular Bypass VITROS 5.1

28 February 2017

IVDs, clinical chemistry

Model: Parallel Bypass, Type 1010; Perpendicular Bypass, Type 1011

MHRA reference: 2017/003/001/291/007

Wassenburg Medical: WASSENBURG ®WD440 Endoscope Washer-Disinfector

1 March 2017

Cssd wash/clean/drying equipment

Model: MY2010, 201, 202

MHRA reference: 2017/002/024/291/022

Zimmer Biomet: Various Polyethylene Implants

24 February 2017

Joint prosthesis, knee MHRA reference: 2017/002/024/701/016

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