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
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Aeonmed: VG70
29 March 2021
Lung ventilators
MHRA reference:
Atos Medical: Provox Life Night HME
30 March 2021
Breathing system components
Model: 8262
MHRA reference:
Beaver Visitec International: BVI CustomEyes Kits and Malosa Kits
26 March 2021
Phacoemulsification / vitrectomy systems
MHRA reference:
Biopsybell: Various Devices
January 2021
Vascular cannula and catheters
MHRA reference:
CareDx: SCORE 6
26 March 2021
IVDs, clinical chemistry
MHRA reference:
Eurofins Forensic Services: Eurofins
02 April 2021
VDs, SARS-CoV-2 PCR test
MHRA reference:
Getinge: Cardiosave Intra-Aortic Balloon Pumps
23 March 2021
Cardiac assist pumps
Model: 0998-XX-0800-XX
MHRA reference:
Medical Enterprises: Synergo
21 March 2021
Therapy tissue ablation
Model: LI932B
MHRA reference:
OptiMed: Cemento Mini Set for Cemento-MP
06 April 2021
Bone Cement and tools
MHRA reference:
Philips Medical Systems: Philips Xper Flex Cardio Physiomonitoring System
April 2021
Monitors, patient
MHRA reference:
Randox Laboratories: Calibration Serum Level 3
29 March 2021
IVDs, clinical chemistry
MHRA reference: