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
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