Field Safety Notices: 5 to 9 October 2020
List of field safety notices (FSNs) from medical device manufacturers from 5 October to 9 October 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
Acutronic: Fabian HFO Neonatal and pediatric ventilator
5 October 2020
Lung ventilators
MHRA reference: 2020/010/006/487/011
Bausch & Lomb: Dk-line, Okta-line
7 October 2020
Injection devices
MHRA reference: 2020/010/006/487/007
Baxter: PrisMax, V2, ROW TherMax Blood Warmer Unit, ROW
2 October 2020
Dialysis, haemodialysis
Model: 955558, 955515
MHRA reference: 2020/010/005/487/015
Elekta: Elekta Unity
May 2020
Radiotherapy
MHRA reference: 2020/005/006/487/001
Invivo Coporation(Philips): Ingenia 1.5T and 3.0T 16 Channel Shoulder Coil
14 September 2020
Magnetic resonance, equipment & accessories
MHRA reference: 2020/009/024/487/013
Maquet - Getinge: Heater-Cooler Unit HCU 40
2 October 2020
Blood/fluid warming systems
Model: 70104.4054; 70105.4917
MHRA reference: 2020/010/006/487/010
Omnia: Set for Implantology / Surgical Kit
22 September 2020
Surgical instrument procedure pack
MHRA reference: 2020/010/006/487/012
Ortho-Clinical: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG and IgG Control, Calibrator
CL2020-246
IVDs, SARS-CoV-2 Immunoassay (Serology)
Model: 6199920 and 6199921
MHRA reference: 2020/010/006/601/004
Roche Diagnostics: Elecsys CA 19-9
July 2020
IVDs, clinical chemistry
MHRA reference: 2020/007/028/291/001
Siemens: ADVIA Chemistry Fructosamine Reagent
September 2020
IVDs, clinical chemistry
MHRA reference: 2020/009/029/601/004
SLE: SLE4000 and SLE5000
September 2020
Lung ventilators
MHRA reference: 2020/010/006/487/008
Spectranetics (Stryker)
2 October 2020
Vascular cannula and catheters
MHRA reference: 2020/010/006/487/006