Field Safety Notice: 27 to 31 January
List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 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
Abbott: Alinity ci-series System Control Module
24 January 2020
IVDs, clinical chemistry
MHRA reference: 2020/001/028/228/008
Abbott: Ellipse ICDs
22 January 2020
Implants, active, defibrillators
Model: implants, active, defibrillators
MHRA reference: 2020/001/023/228/008
Abbott: NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Catheter
29 January 2020
Vascular cannula and catheters
MHRA reference: 2020/001/028/228/002
Baxter Healthcare: Artiset HD DNL HC
29 January 2020
Dialysis, blood lines
Model: 955075
MHRA reference: 2020/001/028/228/012
Boule Medical AB: Medonic
02 January 2020
IVDs, haematology
Model: 1400009
MHRA reference: 2020/001/007/228/008
Chiesi: 145872-01
MD-FSN-CHIESI-2020-001
Inhaled drug delivery system
MHRA reference: 2020/001/029/121/002
Datex-Ohmeda (GE Healthcare): Giraffe Blue Spot PT Lite
GEHC Ref 32072
Therapy, adult phototherapy
MHRA reference: 2020/001/027/228/007
EDEN INNOVATIONS: DOC
26 November 2019
Defibrillators, non implantable
Model: DOC Fix and DOC Mobile
MHRA reference: 2020/001/030/487/005
FH Orthopedics: Brand
24 October 2019
Orthopaedic surgical instruments - cutting tools
MHRA reference: 2020/001/030/487/003
Intelerad Medical Systems Incorporated: IntelePACS
21 January 2020
Picture archiving and communication system (PACS)
MHRA reference: 2020/001/022/701/001
LaproSurge: 5mm curved scissors, L330mm/blade L17mm
16 January 2020
Surgical instruments, articulated cutting
Model: LS001
MHRA reference: 2020/001/020/487/001
Medtronic: HeartWareTM Battery Charger AC Adapter
January 2020
Implantable Ventricular Assist Devices
Model: 1610, 1640
MHRA reference: 2020/001/030/487/002
Mindray Building: Patient Monitors
January 2020
Monitors, patient
Model: VS-900, N12, N15, N17, N19
MHRA reference: 2020/001/015/291/006
Philips Healthcare: Efficia Combined Cable/3 and 5 Leadset
December 2019
Therapy, electrotherapy
Model: See FSN
MHRA reference: 2020/001/028/228/013
Roche Diagnostics: Elecsys CA 19-9
January 2020
Reagent/ assay
MHRA reference: 2020/001/027/228/009
Roche Diagnostics Cobas e 801: Elecsys Troponin T hs.
January 2020
IVDs, clinical chemistry
Model: Cobas e 801
MHRA reference: 2019/010/030/701/035
Siemens Healthcare: Artis pheno
23 January 2020
X Ray, general
MHRA reference: 2020/001/024/601/004
Stryker: LIFEPAK® 15 Monitor/Defibrillator
January 2020
Defibrillators, non implantable
Model: See FSN
MHRA reference: 2020/001/013/228/007
Stryker: SPY-PHI Drape
January 2020
Surgical drapes, gowns, masks
MHRA reference: 2020/001/023/291/001