Field Safety Notice - 19 November to 23 November 2018
List of field safety notices (FSNs) from medical device manufacturers from 19 November to 23 November
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
21 November 2018
IVDs, clinical chemistry
MHRA reference: 2018/011/022/487/015
Abbott: Alinity hq Analyzer Alinity hs Slide Maker Stainer Module
26 October 2018
IVDs, haematology
MHRA reference: 2018/010/016/487/012
Baxter: FORCEPS, COUPLER GEM4183C
19 November 2018
Surgical instruments, articulated holding
Model: 5193-06001-010
MHRA reference: 2018/011/019/291/014
Biohit: Lactose intolerance quick test
14 November 2018
IVDs, clinical chemistry
MHRA reference: 2018/011/016/291/005
GE: Giraffe Omnibed
FMI 32063
Infant incubators
MHRA reference: 2018/011/012/291/001
Getinge: Fibrocleaner
CAPA227500
Cssd wash/clean/drying equipment
MHRA reference: 2018/011/021/487/018
Philips: Efficia 3/5 ECG Trunk Cable, AAMI/IEC
November 2018
Defibrillators, non-implantable
Model: 989803160641
MHRA reference: 2018/011/021/487/019
Philips: CombiDiagnost
16 October 2018
X Ray, fluoroscopy systems
Model: 709030
MHRA reference: 2018/011/019/291/001
Philips: HeartStart MRx Lithium Ion Module (Rechargeable)
November 2018
Defibrillators, non-implantable
M3538A
MHRA reference: 2018/010/031/487/020
VascoMed: TC-115 Balloon
November 2018
Pacemakers, external
MHRA reference: 2018/011/019/701/005