Field Safety Notices: 30 August to 3 September 2021
List of field safety notices (FSNs) from medical device manufacturers from 30 August to 3 September 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.
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
Balt: SILK VISTA
12 April 2021
Intracranial flow diverters / stents
Model: All
MHRA reference: 2021/008/027/291/001
Botiss: Cerabone Plus
30 July 2021
Implants, dental
MHRA reference: 2021/008/025/579/011
Edan: Central Monitoring System
11 August 2021
Monitors, Patient
Model: MFM-CMS
MHRA reference: 2021/008/027/291/004
Elekta: MOSAIQ
August 2021
Radiotherapy
MHRA reference: 2021/008/031/291/004
EndoTools: Endomina v2
19 April 2021
Endoscopes, flexible
Model: IA-EM8616610505-00
MHRA reference: 2021/008/024/601/501
GE Healthcare: CENTRICITY PACS IW WITH UNIVERSAL VIEWER
GEHC Ref#85456
Picture archiving and communication system (PACS)
MHRA reference: 2021/008/026/291/011
Gore: CARDIOFORM Septal Occluder
September 2021
Implants, non-active, cardiac appendage and septal defect occluders / plugs
MHRA reference: 2021/008/030/701/024
Philips: CombiDiagnost R90
August 2021
X Ray, fluoroscopy systems
Model: 709030
MHRA reference: 2021/008/031/291/001
Philips: Ingenia 1.5T, 1.5T S, 1.5T Evolution, Ingenia 3.0T, 3.0T CX, Achieva 3.0T, Ingenia Elition S & X
FCO78100530
Magnetic resonance, equipment & accessories
Model: 781341, 781342, 781315, 781271, 781277, 781357, 781358
MHRA reference: 2021/008/027/291/014
Qiagen: QIAstat-Dx Respiratory SARS-CoV-2 Panel
23 August 2021
IVDs, SARS-CoV-2 PCR test
MHRA reference: 2021/008/025/291/003
Roche: Cobas EGFR Mutation Test v2
SBN-RDS-ML-2021-011
IVD, genetic testing
MHRA reference: 2021/008/027/291/013
Stryker: Cartilage Substitute
25 August 2021
Cartilage substitute
MHRA reference: 2021/008/027/291/003
ThermoFisher Scientific: B·R·A·H·M·S Solution 2 KRYPTOR GOLD
11 June 2021
IVD, genetic testing
MHRA reference: 2021/006/010/487/001
Zimmer Biomet: Various Spinal Implants
30 August 2021
Spinal implants
MHRA reference: 2021/008/031/291/003