Field Safety Notices - 22 June to 26 June 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 22 June to 26 June 2020

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

View a list of FSNs published since January 2020

View FSNs since November 2014

FSNs before this date are on the National Archives website

Abbott: Alinity ci-series System Control Module

19 June 2020

IVDs, clinical chemistry

MHRA reference: 2020/006/023/487/001

Abbott: Alinity h‐series

18 June 2020

IVDs, haematology

MHRA reference: 2020/006/022/487/006

ArjoHuntleigh AB: Lifeguard

22 June 2020

Stretchers

LG 20, LG 50, LG 55

MHRA reference: 2020/006/002/601/003

Cook Medical: Zilver® PTX® Drug-Eluting Peripheral Stent

2020FA-0001

Implants, non active, peripheral vascular stents

MHRA reference: 2020/006/010/487/001

Draeger: Perseus A500

June 2020

Anaesthetic machines & monitors

MHRA reference: 2020/006/024/487/001

Elekta Instruments: Leksell® Vantage™ Arc System

June 2020

Surgical navigation system and accessories

MHRA reference: 2020/006/008/487/004

Groupe SEBBIN: Mammary implants

27 May 2020

Implants, Breast

Model: LS5X, LS7X, LS9X, LSMXX, LSAXX

MHRA reference: 2020/006/005/601/006

Hocoma: LokomatPro L6

12 June 2020

Therapy, standing & walking

MHRA reference: 2020/005/021/487/001

Jenx: Jenx

04 June 2020

Supportive seating

Model: DM36, JB26, MB14, MB31

MHRA reference: 2020/006/005/601/005

Maquet(Getinge): Single holder for oxygenator neo./ped

19 June 2020

Infusion & transfusion, heart lung circuits

Model: Single holder for oxygenator neo./ped. as a supplement to holder arm (QUADROX-i, QUADROX) (Article No. 70104.7495, REF No. HKHZ 19)

MHRA reference: 2020/006/019/487/001

Omnimate: Sure Spec

3 June 2020

Surgical instruments, articulated holding

Model: Sure Spec - D5302 D5303 D5304

MHRA reference: 2020/006/017/601/003

RMS: Marley

1 June 2020

Buggies for disabled people

MHRA reference: 2019/010/009/401/010

Roche: MagNA Pure 96 System

3 June 2020

IVDs, viral microbiology

Model: 06541089001

MHRA reference: 2020/006/005/291/008

Steripack: Syringe 10 ml with 0,9% sodium chloride (5ml fill)

1 June 2020

Vascular cannula/catheter accessories

MHRA reference: 2020/006/002/291/001

Siemens: ADVIA Chemistry/Atellica CH/Dimension Vista

May 2020

IVDs, clinical chemistry

MHRA reference: 2020/006/018/601/007

Siemens Healthcare Diagnostics: ADVIA Centaur XP Rubella G (Rub G) & ADVIA Centaur XP Rubella M (Rub M)

June 2020

IVDs, viral microbiology

Model: Catalogue number: 10310283 & 10310285

MHRA reference: 2020/006/017/601/005

Smith & Nephew: R3 Acetabular Shells

8 June 2020

Joint prosthesis, hip

MHRA reference: 2020/004/027/487/001

Stryker: Infant Child Reduced Energy Electrodes

12 May 2020

Defibrillators, non implantable

Model: Infant child reduced energy electrodes 3202380-006, 3202784-009

MHRA reference: 2020/006/024/291/005

Stryker: External Defibrillator Electrode, Pediatric,Single

23 June 2020

Defibrillators, non implantable

Model: LIFEPAK 500

MHRA reference: 2020/006/024/487/003

Sunrise Medical: Easy Life & Easy Life T

07200100/84600000

Easy life & easy Life T

MHRA reference: 2020/005/027/291/001

Updates to this page

Published 29 June 2020