Field Safety Notices - 22 to 26 March 2021
List of field safety notices (FSNs) from medical device manufacturers from 22 March to 26 March 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.
Baxter: COLLEAGUE PUMP, EVO IQ LVP, EVO IQ SYR
March 2021
Electrically powered infusion pump
Model: COLLEAGUE SINGLE CHANNEL, CXE & MONO, COLLEAGUE TRIPLE CHANNEL, CXE & MONO, EVO IQ LVP, EVO IQ SYR
MHRA reference 2021/003/022/487/002
BEMER: Classic and Pro therapy systems
11 January 2021
Light source
Model: 410200, 420200, 410100, 420100)
MHRA reference: 2020/012/014/487/012
bioMérieux: VIDAS CMV IgM
March 2021
IVDs, Viral Microbiology
Model: 30205
MHRA reference: 2021/003/023/487/004
Bucher: Side and rear loading device
March 2021
Retaining Mechanism/Clamp
Model: Side And Rear-Loading Device Assy P/N 1354610 of Side And Rear-Loading Device P/N 1354600 or P/N 1366000
MHRA reference: 2021/003/019/601/006
Caire Diagnostics: Fenom Pro Asthma Monitor
26 February 2021
Lung Function Analyser
Model: 100107 to 100651
MHRA reference: 2021/003/017/701/005
Delcath Systems: CHEMOSAT HDS
9 March 2021
Infusion & transfusion, autologous
Model: 420025, 420008
MHRA reference: 2021/003/012/701/036
Diffuplast: ExactaMix
23 March 2021
Feeding systems and tubes
Model: E1402OD, E1302OLPF
MHRA reference 2021/002/024/701/050
GE Healthcare: Centricity High Acuity Critical Care (CHA CC) Systems and Centricity Critical Care (CCC) Systems
23 March 2021
Patient health record information system
Model: CHA CC or CCC
MHRA reference: 2021/003/024/291/001
Medtronic: Surgiwand II suction and irrigation devices
March 2021
Surgical Suction
Model: 178083 (Class IIa), 178093, 178094 (both Class IIb)
MHRA reference: 2021/003/023/487/006
Miethke: M.Scio
16 February 2021
CSF drainage kit, lumbar
Model: FV915X; FV916X; FV913X; FV914X; FV924X; FV925X
MHRA reference: 2021/003/019/291/003
Ortho Clinical Diagnostics: ORTHO VISION Analyzer and ORTHO VISION Max Analyzer (for BioVue cassettes)
22 March 2021
Blood Grouping Analyser
Model: 6904579, 6904578
MHRA reference: 2021/003/017/601/002
Radiometer Medical: PICO70 Arterial Blood Sampler
Radiometer
Blood Sample Collection Equipment
Model: 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, 956-547
MHRA reference: 2021/003/019/291/001
Welch Allyn: AM12M Acquisition Module
FSN MOD1326
Software
Model: Surveyor S19, Surveyor S12, ELI 380, ELI 280, AM12M Kits, AM12M Module
MHRA reference: 2021/003/023/487/014