Field Safety Notices: 3 to 7 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 January 2022
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
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott Molecular: Alinity m system
06 December 2021
IVDs, SARS-CoV-2 PCR Test
MHRA reference: 2021/012/008/701/052
bioMérieux: ID 32 C
07 January 2022
IVDs, bacteriology
MHRA reference: 2022/001/006/291/004
CooperSurgical: Milex Gellhorn
14 September 2021
Implants, non active, implantable incontinence and prolapse devices
Model: MXKPGSS2-1/4; MXPGSS2-1/4; MXPGSS2-3/4
MHRA reference: 2021/009/020/601/001
CooperVision : Hy-Care; All in one light; Refine one step; comfortvue; comfort drops; preservative free saline
REC030
Contact lenses, care products
Model: CLC005; CLC001; CLC003; CLC013; CLC009; CLC014
MHRA reference: 2021/012/021/601/500
Dedalus Medchart: Med Chart
02 November 2021
Software as a medical device (SaMD)
Model: v8.3.1.3.7.8, v10.1, v11, v12
MHRA reference: 2021/012/021/601/002
GE Vingmed Ultrasound: Vscan Extend
GEHC 73091
Ultrasound, imaging
MHRA reference: 2022/001/006/291/003
Imtmedical: Diagnostic Package Pulse Oxymetry/Capnography
23 December 2021
Lung ventilators
Model: 301.113.000; 301.114.000
MHRA reference: 2021/012/023/701/051
Intuitive Surgical: Reducer ,IS4000,12-8MM, Disposable
ISIFA2021-08-R
Surgical instruments, minimal access
Model: 470381-11
MHRA reference: 2022/001/006/291/002
Medtronic: Percept PC BrainSense
January 2022
Implantable neuro stimulators
Model: B35200
MHRA reference: 2021/010/015/579/002
Philips Medical: Allura Xper, UNIQ and CV20 systems
December 2021
X Ray, fluoroscopy systems
Model: 722003, 722005, 722006, 722008, , 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722031, 722033, 722034, 722036, 722038, 722039
MHRA reference: 2021/011/026/487/019
SynCardia: TAH-t System
21 December 2021
Implantable ventricular assist devices
MHRA reference: 2021/012/023/601/001