Field Safety Notices: 29 November to 3 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 29 November to 3 December 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.
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Acumed: T15 Stick Fit Hexalobe Drivers
05 November 2021
Orthopaedic Surgical instruments - Insertion/extraction tools
Model: 80-0760
MHRA reference:
Chalice Medical: one-way valve
26 November 2021
Infusion & transfusion, heart lung circuits
MHRA reference:
Illumina: VeriSeq NIPT Solution v2 Brand
27 October 2021
IVD, genetic testing
Model: 20030577
MHRA reference:
Medtronic: Abre Venous Self-expanding Stent System
November 2021
Implants, non active, peripheral vascular stents
Model: Several
MHRA reference:
Philips: BV Endura, BV Pulsera, Veradius Unity
November 2021
X Ray, general
MHRA reference:
Philips Medical Systems: Allura Xper, UNIQ and CV20 systems
November 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:
Siemens Healthcare: Sensis Vibe Hemo & Sensis / Sensis Vibe Combo
November 2021
Electrophysiology measurement
MHRA reference: