Field Safety Notices - 05 April to 09 April 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 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
Aeonmed: VG70
29 March 2021
Lung ventilators
MHRA reference: 2021/003/031/291/002
Atos Medical: Provox Life Night HME
30 March 2021
Breathing system components
Model: 8262
MHRA reference: 2021/003/025/601/002
Beaver Visitec International: BVI CustomEyes Kits and Malosa Kits
26 March 2021
Phacoemulsification / vitrectomy systems
MHRA reference: 2021/004/006/291/001
Biopsybell: Various Devices
January 2021
Vascular cannula and catheters
MHRA reference: 2021/003/030/487/017
CareDx: SCORE 6
26 March 2021
IVDs, clinical chemistry
MHRA reference: 2021/003/024/701/061
Eurofins Forensic Services: Eurofins
02 April 2021
VDs, SARS-CoV-2 PCR test
MHRA reference: 2021/003/031/291/001
Getinge: Cardiosave Intra-Aortic Balloon Pumps
23 March 2021
Cardiac assist pumps
Model: 0998-XX-0800-XX
MHRA reference: 2021/004/006/291/017
Medical Enterprises: Synergo
21 March 2021
Therapy tissue ablation
Model: LI932B
MHRA reference: 2021/003/023/601/005
OptiMed: Cemento Mini Set for Cemento-MP
06 April 2021
Bone Cement and tools
MHRA reference: 2021/004/006/701/058
Philips Medical Systems: Philips Xper Flex Cardio Physiomonitoring System
April 2021
Monitors, patient
MHRA reference: 2021/004/006/291/009
Randox Laboratories: Calibration Serum Level 3
29 March 2021
IVDs, clinical chemistry
MHRA reference: 2021/004/001/601/017