Field Safety Notices - 11 to 15 May 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 2020
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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FSNs before this date are on the
Abbott: MERLIN鈩� PATIENT CARE SYSTEM (PCS), Mod. 3650
12 May 2020
Implants, active, cardiac programmers and remote monitoring
Model: PROGRAMMER SOFTWARE VERSION 25.0.2 Rev 3, Mod. 3330
MHRA reference:
Becton Dickinson: BD PosiFlush鈩� XS 10mL Syringe
21 April 2020
Vascular cannula/catheter accessories
MHRA reference:
Biosense Webster: PENTARAY庐 NAV CATHETER; PENTARAY庐 NAV eco CATHETER
6 April 2020
Vascular cannula and catheters
MHRA reference:
Elekta: Elekta Unity
May 2020
Radiotherapy
MHRA reference:
Greiner: MiniCollect 9NC Coagulation Tube
4 March 2020
IVDs, specimen receptacles
MHRA reference:
Olympus: Olympus Diego Elite High speed drill burrs
May 2020
Surgical power tools
Model: MASTOID BURR 3.0 X 60 MM DIA & MASTOID BURR 4.0 X 60 MM FLUTED
MHRA reference:
Umano Medical: ook snow, ook snow MN, ook cocoon
4 May 2020
Beds and accessories
Model: FL36
MHRA reference: