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.
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Abbott Molecular: Alinity m system
06 December 2021
IVDs, SARS-CoV-2 PCR Test
MHRA reference:
bioM茅rieux: ID 32 C
07 January 2022
IVDs, bacteriology
MHRA reference:
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:
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:
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:
GE Vingmed Ultrasound: Vscan Extend
GEHC 73091
Ultrasound, imaging
MHRA reference:
Imtmedical: Diagnostic Package Pulse Oxymetry/Capnography
23 December 2021
Lung ventilators
Model: 301.113.000; 301.114.000
MHRA reference:
Intuitive Surgical: Reducer ,IS4000,12-8MM, Disposable
ISIFA2021-08-R
Surgical instruments, minimal access
Model: 470381-11
MHRA reference:
Lerado: Li-Tech Marathon Mobility Scooters Batteries
Li-Tech Marathon Mobility Scooters
Model: all models
MHRA reference:
Medtronic: Percept PC BrainSense
January 2022
Implantable neuro stimulators
Model: B35200
MHRA reference:
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:
SynCardia: TAH-t System
21 December 2021
Implantable ventricular assist devices
MHRA reference:
Tridentify: QTA Tracer 2.0
8 January 2022
MHRA reference: