Field Safety Notices: 20 to 24 September 2021
List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 September 2021
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Acumed:Medium Ratcheting Driver Handle
20 September 2021
Orthopaedic surgical instruments - insertion/extraction tools
Model: 80-0663
MHRA reference: 2021/009/020/701/017
BioMerieux:MYLA V4.7, V4.8 SOFTWARE
21 September 2021
IVDs, blood transfusion
MHRA reference: 2021/009/017/487/002
GE Healthcare: SIGNA Premier RX29.1 SIGNA Architect DV29.1 SIGNA Pioneer PX29.1 Discovery MR750 3.0T, Discovery MR750w 3.0T DV29.1 Optima MR450w 1.5T DV29.1
1.5T SIGNA HDxt HD29.1 SIGNA Artist DV29.1 SIGNA Voyager VX29.1 SIGNA Creator, SIGNA Explorer SV29.1
15 September 2021
Magnetic resonance, equipment & accessories
MHRA reference: 2021/009/016/291/010
Getinge: CARDIOSAVE battery pack, Li-Ion
21 September 2021
Cardiac assist pumps
MHRA reference: 2021/009/022/579/003
Medtronic: Activa Clinician Programmer Application A610
September 2021
Implantable neuro stimulators
MHRA reference: 2021/009/017/487/001
Teleflex: Arrow Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device
September 2021
Vascular cannula and catheters
MHRA reference: 2021/009/022/579/002