Field Safety Notices - 13 to 17 April 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 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
AVANOS: CORFLO* PEG Kit with ENFit® Connector
07 April 2020
Feeding systems and tubes
MHRA reference: 2020/003/030/487/008
EBR System: WiSE CRT Electrode-Catheter and Delivery Sheath
14 April 2020
Implants, active, intracardiac (leadless)
Model: 1000, 2000
MHRA reference: 2020/004/015/291/002
Fast Track Diagnostics: FTD Vesicular Rash
April 2020
IVDs, bacteriology
Model: Siemens Material Number 10921714 / 10921715
MHRA reference: 2020/004/014/291/001
Philips Medical: HeartStart XL Defibrillator/Monitor
26 March 2020
Defibrillators, non implantable
Model: M4735A
MHRA reference: 2020/004/016/291/001
Philips Medical: TraumaDiagnost
17 Feb 2020
X Ray, ancillary equipment and accessories
Model: 70411, 704030, 72001, 720011, 720013, 720020, 720050
MHRA reference: 2020/004/009/487/008
Roche Diagnostics: Elecsys Troponin T hs
April 2020
IVDs, clinical chemistry
MHRA reference: 2020/004/015/291/001
SENTINEL: Immuno Control Set
February 2020
IVDs, immunology
MHRA reference: 2020/003/012/487/019
SENTINEL: Plasmaproteins Cal 3x, Plasmaproteins Cal
06 February 2020
IVDs, immunology
MHRA reference: 2020/004/016/487/004
Siemens Healthcare: Artis pheno
April 2020
X Ray, fluoroscopy systems
MHRA reference: 2020/004/014/601/002
The Binding Site: Optilite Analyser
09 April 2020
IVDs, clinical chemistry
Model: IE700
MHRA reference: 2020/004/009/601/003
Thermo Fisher Scientific: Oxoid
08 April 2020
IVDs, bacteriology
Model: PO1210A
MHRA reference: 2020/004/013/601/002