Field Safety Notices - 27 April to 1 May 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 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: ARCHITECT iGentamicin Reagent Ki
24 April 2020
IVDs, clinical chemistry
MHRA reference: 2020/004/027/487/004
Becton Dickinson: BD BBL™ Gram Crystal Violet 250mL & Grain Stain Ki
30 April 2020
IVDs, bacteriology
MHRA reference: 2020/004/028/487/005
GE Healthcare: Carescape One
FMI 36145
Monitors, patient
MHRA reference: 2020/004/030/487/010
Merit Medical: SCOUT® Guide and SCOUT CHECK® Handpiece
Over label devices
Surgical navigation system and accessories
MHRA reference: 2020/004/024/487/004
Radiometer Medical: ABL80 FLEX/CO-OX
27 April 2020
IVDs, extra laboratory testing
Model: ABL80 FLEX (393-839) and ABL80 CO-OX (393-841)
MHRA reference: 2020/004/023/291/005
Schiller: MedilogAR
07 April 2020
ECG
MHRA reference: 2020/004/028/487/004
Siemens Healthcare: Artis icono
April 2020
X Ray, fluoroscopy systems
MHRA reference: 2020/004/028/601/002
Siemens Healthcare GmbH: Cios Spin & Cios Alpha
April 2020
X Ray, fluoroscopy systems
Model: VA20, VA30
MHRA reference: 2020/004/028/601/001
Smith & Nephew: R3 Acetabular Shells
22 April 2020
Joint prosthesis, hip
MHRA reference: 2020/004/027/487/001
SunTech Medical: SunTech, Oscar 2
16 April 2020
Monitors, blood pressure
Model: 250
MHRA reference: 2020/004/024/487/001
Zimmer Biomet: Polyethylene Implants
30 April 2020
Various Devices affected
MHRA reference: 2020/004/030/487/009