Field Safety Notices: 31 January to 4 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 31 January to 4 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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Acandis: DERIVO 2 Embolisation Device
20 January 2022
Intracranial flow diverters / stents
MHRA reference:
Bolder Surgical: CoolSeal Generator
28 January 2022
Surgical, diathermy
MHRA reference:
Invacare: K眉schall Compact & Champion
24 January 2022
Wheelchairs, manual
MHRA reference:
Medtronic: MiniMed 640G Insulin Pump (35983); 670G Insulin Pump (35983); 720G Insulin Pump (64889), 740G Insulin Pump (64890); 770G Insulin Pump (64891); 780G Insulin Pump (64891)
January 2022
Infusion systems
Pump models: MMT-1711, MMT-1712; MMT-1781, MMT-1782; MMT-1809, MMT-1810; MMT-1811, MMT-1812; MMT-1881, MMT-1882; MMT-1885, MMT-1886.
Kit models: MMT-1751, MMT-1752; MMT-1761, MMT-1762; MMT-1859, MMT-1860; MMT-1861, MMT-1862; MMT-1891, MMT-1892; MMT-1895, MMT-1896.
MHRA reference:
Medtronic: Reveal LINQ with TruRhythm Insertable Cardiac Monitoring Systems
November 2021/FA978 Phase II
Implants, active, monitors and recorders
Model: LNQ11
MHRA reference:
MMD: Oracol+
September 2018
IVDs, specimen receptacles
Model: S14
MHRA reference:
Ossur: RESOLVE HALO
January 2022
Osteosynthesis, external fixators
Model: 505300T, 505400T, 505500T, 540C, 540D, 540V2, 515300T, 515400T, 515500T, 553CB, 554CB , 555CB , 510300CH, 510400CH, 510500CH, 515300C, 515400C, 515500C, 510400DH, 510500DH, 505300D, 505400D, 505500D, 515300D, 515400D , 515500D, 505300V2, 505400V2, 505500V2 , 515300V2 ,515400V2, 515500V2
MHRA reference:
Stryker
January 2022
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference:
Trinity Biotech: Menarini Premier Hb9210 Diluent Reagent
21 December 2021
IVDs, haematology
MHRA reference:
Zimmer Biomet: Comprehensive Shoulder System & Arcos
27 January 2022
Joint prosthesis, shoulder
MHRA reference: