Field Safety Notices: 14 to 18 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 2022.
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.
Abbott Molecular: Integrated Reaction Unit (IRU)
11 February 2022
IVDs, clinical chemistry
MHRA reference: 2022/002/015/701/023
Astraia: Software
10 February 2022
Ultrasound, imaging
MHRA reference: 2022/002/014/291/018
B.Braun Melsungen: INF.SP.LINE,TRANS,PVC,LL,250CM-EU
08 February 2022
Infusion & transfusion, administration sets
Model: Infusomat Space Line
MHRA reference: 2022/002/009/601/001
BioMérieux SA: VIDAS CMV IgM
11 FEB 2022
IVDs, viral microbiology
MHRA reference: 2022/002/014/291/004
Breas Medical: Ventilator Trolley
31 January 2022
Lung ventilators
Model: 007384
MHRA reference: 2022/001/027/601/503
Chromsystems Instruments & Chemicals: Analytical column, MassChrom Free Metanephrines
19 January 2022
IVDs, clinical chemistry
Model: 81100
MHRA reference: 2022/001/021/601/500
CooperVision: Hy-Care Multipurpose Contact Lens Care Solution
D6F-0502
Contact lenses & shells
Model: CLC005
MHRA reference: 2022/002/009/601/500
Corin Ltd: Trinity Acetabular Hip System
26 January 2022
Orthopaedic surgical instruments - measuring tools
Model: 921.109
MHRA reference: 2022/001/028/601/505
Drägerwerk: Evita V300; Evita V500; Babylog VN500
August 2021
Lung ventilators
MHRA reference: 2021/008/018/487/001
ETAC A/S: Molift
17 August 2021
Hoists and slings
MHRA reference: 2021/010/011/579/008
IBA: ProteusPLUS, ProteusONE
11 February 2022
Radiotherapy
Model: Proteus 235
MHRA reference: 2022/002/014/291/017
Nissha Medical Technologies: CLARAVUE
16 February 2022
Electrophysiology measurement
MHRA reference: 2022/002/007/487/001
Philips Medical Systems: Philips StentBoost Live used with Philips Allura a
02 February 2022
X Ray, Fluoroscopy Systems
Model: StentBoost Live: 459801781661
MHRA reference: 2022/002/007/487/009
Philips Ultrasound: Esophageal/Rectal Temperature Probes
February 2022
Patient temperature measurement
MHRA reference: 2022/002/014/291/002
Siemens Healthcare: Ysio10281013
14 February 2022
X Ray, general
MHRA reference: 2022/002/014/601/001
Siemens Healthcare Diagnostics: Atellica CH Lithium_2 (LITH_2) Lithium test system Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Hemoglobin A1c test system Atellica CH Calcium_2 (CA_2) Calcium test system Atellica CH Fructosamine (Fruc) Glycosylated hemoglobin assa
February 2022/ACHC22-2.A.OUS
IVDs, clinical chemistry
Model: 11532401, 11097536, 11097644, 11097637
MHRA reference: 2022/002/014/601/500
Siemens Healthcare: ARTIS icono / pheno
February 2022/DE MF 000006122
X Ray, fluoroscopy systems
Model: 11327600, 11327700, 10849000
MHRA reference: 2022/002/014/601/006
Siemens Healthcare: Artis systems with syngo Application Software version VE20
February 2022/AX006/22/S
X Ray, fluoroscopy systems
MHRA reference: 2022/002/014/601/003
Siemens Medical Solutions: Acuson Juniper 11361954
VA10D/VA10E/VA10F
Ultrasound, imaging
MHRA reference: 2022/002/004/601/501
Stryker: DARCO Non-Locking Screw 2.7 x 26mm
February 2022
Osteosynthesis, bone screws
MHRA reference: 2022/002/014/291/003
Tandem Diabetes Care: t:slim X2 Insulin Pump
February 2022
Infusion systems
MHRA reference: 2022/002/009/701/176