Field Safety Notices: 07 December to 11 December 2020
List of field safety notices (FSNs) from medical device manufacturers from 07 December to 11 December 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.
Latest FSNs
View the latest FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Beckman Coulter: Access Unconjugated Estriol(Update to FSN wk 14 – 18 September 2020)
26 November 2020
IVDs, clinical chemistry
Model: Not applicable
MHRA reference: 2020/009/016/601/001
Becton Dickinson: BD Regional Block Needle
09 December 2020
Injection devices
MHRA reference: 2020/012/004/291/006
GE: Carestation 600 Series
07 December 2020
Anaesthetic machines & monitors
MHRA reference: 2020/012/007/291/005
GS Elektromed: corpuls3
01 December 2020
Defibrillators, non implantable
Model: 04301
MHRA reference: 2020/012/010/487/007
Hamilton Medical: HAMILTON-H900 Humidifier
04 December 2020
Humidifiers
MHRA reference: 2020/012/007/487/003
Helena BioSciences: K-ACT Actalyke Clotting Test Tubes
20 November 2020
Coagulation
MHRA reference: 2020/011/023/487/003
IM Med: iM CleanStage Two
01 December 2020
Disinfectants for medical devices
Model: 110205
MHRA reference: 2020/012/009/601/004
MAR-MED: Tourni-Cot Universal
04 December 2020 Surgical equipment, tourniquets Model: Tourni-Cot Universal - TCU - 6001 MHRA reference: 2020/012/007/291/002
Medtronic: CareLinkTM Software; Medtronic CareLink® Personal Therapy Management Software for Diabetes
December 2020
Software as a medical device (SaMD)
MHRA reference: 2020/012/009/487/008
Siemens: Chemistry Calibrator (Update to FSN wk 15 – 19 June 2020)
August 2020 IVDs, clinical chemistry MHRA reference: 2020/006/012/601/001
Siemens Healthcare: Atellica IM 1300/1600 and CH 930 Analyzers
November 2020
IVDs, clinical chemistry
MHRA reference: 2020/012/009/601/007
SIS MEDICAL: OPN NC PTCA Dilatation Catheter
October 2020
Vascular cannula and catheters
MHRA reference: 2020/011/006/601/004
Smiths Medical: Portex Loss Of Resistance Device
03 December 2020
Injection devices
Model: 100/398/000
MHRA reference: 2020/012/007/291/003