Field Safety Notices - 6 to 9 April 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 6 to 9 April 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 FSN
Abbott: Accelerator APS Aliquoter Module
2 April 2020
IVDs, clinical chemistry
MHRA reference: 2020/004/007/291/001
Baxter: Prismaflex Control Unit, PrisMax
7 April 2020, FA-2020-016
Dialysis, haemofilters
MHRA reference: 2020/004/002/291/009
Baxter: Prismaflex, PrismaX CRRT machines
7 April 2020
Dialysis, haemofilters
MHRA reference: 2020/004/002/291/009
Beckman Coulter: iChemVELOCITY & iQ200 Urine Analyzer
6 April 2020
IVDs, clinical chemistry
MHRA reference: 2020/004/006/601/002
Elekta: Monaco RTP System
April 2020
Radiotherapy planning and verification
MHRA reference: 2020/004/007/291/004
EUROIMMUN Medizinische Labordiagnostika AG: Anti-Parvovirus B19 ELISA (IgM)
7 April 2020
IVDs, viral microbiology
MHRA reference: 2020/004/003/701/036
Magstim: PSU Stim Interconnecting Cable
17 March 2020
External brain stimulation
MHRA reference: 2020/004/006/291/001
Maquet (Getinge): Flow-I C20, Flow-I C30, Flow-I C40 Flow-c and Flow-e
25 March 2020
Anaesthetic machines & monitors
MHRA reference: 2020/003/026/291/001
Medtronic: HVAD™ Pump Implant Kit, HVAD™ Pump Outflow Graft, HVAD™ Implant
Accessories Kit
April 2020
Implantable ventricular assist devices
Model: 1104, 1125, 1153 HVAD™ Pump Implant Kit, HVAD™ Pump Outflow Graft, HVAD™
Implant Accessories Kit
MHRA reference: 2020/004/007/291/005
Mindray: WATO and A-Series Anesthesia System Consideration for use as a Ventilator
25 March 2020
Anaesthetic machines & monitors
MHRA reference: 2020/004/006/291/004
QIAGEN: Therascreen EGFR RGQ PCR Kit (24), V2, REF 874111, Therascreen EGFR
Plasma RGQ PCR Kit (24), REF 870311
8 April 2020
IVD, genetic testing
MHRA reference: 2020/004/008/291/001
Radiometer Medical: AQT90 FLEX analyzers
FAN 915-409
IVDs, clinical chemistry
Model: 393-838
MHRA reference: 2020/004/008/291/002
Siemens Healthcare: Dade Ci-Trol 1
March 2020
Coagulation
MHRA reference: 2020/003/020/291/006
Siemens Healthcare: Coagulation Factor V Deficient Plasma
April 2020
Coagulation
MHRA reference: 2020/004/007/291/013