Field Safety Notices: 7 to 11 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 February 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
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Biomerieux: VIDAS High sensitive Troponin I
04 January 2022
IVDs, clinical chemistry
MHRA reference:
ConvaTec: Combihesive and Natura
2021-011
Ostomy and continence equipment
MHRA reference:
GE Healthcare: MR superconducting magnets
#60983
Magnetic resonance, equipment & accessories
MHRA reference:
GE Healthcare: MR superconducting magnets
60983
Magnetic resonance, equipment & accessories
Model: MRI
MHRA reference:
Getinge: ED-FLOW, ED-FLOW SD
26 January 2022
Cssd wash/clean/drying equipment
MHRA reference:
Huntleigh: Dopplex
31 January 2022
Ultrasound, imaging
Model: DIOP8
MHRA reference:
Microport Scientific: PROCOTYL P SUPERPATH IMPACTOR ADAPTOR
24 November 2021
Orthopaedic surgical instruments - impacting tools
Model: PPSP0110
MHRA reference:
Regal: Lotus Adaptor
07 January 2022
Prostheses
Model: 2-01-S400L=LA-01
MHRA reference:
Smiths Medical: Level 1 Fast Flow Fluid Warming System and Level 1 NORMOFLO Irrigation System
01 February 2022
Blood/fluid warming systems
MHRA reference:
Summit Medical: HiVac MultiMix
03 February 2022
Bone cement and tools
MHRA reference:
Surgical Holdings: MOORE FEMORAL HEAD EXTRACTOR WITH T-HANDLE 15.2CM (6``) LONG
20 January 2022
Orthopaedic surgical instruments - insertion/extraction tools
Model: SC-OR/N005
MHRA reference:
W.O.M: HysteroLux Fluid Management System
25 October 2021
Endoscopes, rigid
Model: PH304
MHRA reference: