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.
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FSNs before this date are on the
Abbott: ARCHITECT iGentamicin Reagent Ki
24 April 2020
IVDs, clinical chemistry
MHRA reference:
Becton Dickinson: BD BBL鈩� Gram Crystal Violet 250mL & Grain Stain Ki
30 April 2020
IVDs, bacteriology
MHRA reference:
GE Healthcare: Carescape One
FMI 36145
Monitors, patient
MHRA reference:
Merit Medical: SCOUT庐 Guide and SCOUT CHECK庐 Handpiece
Over label devices
Surgical navigation system and accessories
MHRA reference:
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:
Schiller: MedilogAR
07 April 2020
ECG
MHRA reference:
Siemens Healthcare: Artis icono
April 2020
X Ray, fluoroscopy systems
MHRA reference:
Siemens Healthcare GmbH: Cios Spin & Cios Alpha
April 2020
X Ray, fluoroscopy systems
Model: VA20, VA30
MHRA reference:
Smith & Nephew: R3 Acetabular Shells
22 April 2020
Joint prosthesis, hip
MHRA reference:
SunTech Medical: SunTech, Oscar 2
16 April 2020
Monitors, blood pressure
Model: 250
MHRA reference:
Zimmer Biomet: Polyethylene Implants
30 April 2020
Various Devices affected
MHRA reference: