Field Safety Notices: 1 to 4 September 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 1 to 4 September 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 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: ARCHITECT Galectin‐3 Reagent
28 August 2020
IVDs, clinical chemistry
MHRA reference: 2020/009/001/291/004
Advanced Medical Solutions: ACTIVHEAL Hydrogel
2 September 2020
Haemostatic agents
Model: 10014007
MHRA reference: 2020/008/011/601/008
Allmed Medical Products: X-Ray Gauze Swaps
FSN 20-02
Basic dressings, absorbents, swabs, procedure packs
Model: AL002XR, AL004XRA-Bulk, AL005XR, AL006XR, AL007XR, AL008XR, AL017XR, AL021XR, AL026XR
MHRA reference: 2020/009/001/291/002
Bolton Surgical: Bolt Cutter 470mm
200601/20-001
Surgical instruments, non-articulated
Model: Bolt Cutter 470mm - 14-2922-00
MHRA reference: 2020/008/026/487/002
Dako: Autostainer Link 48/Plus/Classic
CAPA00852
IVDs, cytopathology & histopathology
Model: AS480; AS100; S3800; S3400
MHRA reference: 2020/009/001/291/005
DragonMobility
6 March 2020
Wheelchairs, powered
Model: SnapDragon
MHRA reference: 2019/012/010/601/007
Fresenius Medical Care: AquaC UNO H
28 August 2020
Dialysis, haemodialysis
Model: F00002272, F00003544, F00003546, F00004565
MHRA reference: 2020/009/001/291/001
FUJIFILM Medical System: Synapse PACS
17 August 2020
Picture Archiving and Communication System (PACS)
MHRA reference: 2020/009/002/487/013
Gentian: Gentian Cystatin C Calibrator
1 September 2020
IVDs, clinical chemistry
MHRA reference: 2020/009/003/291/003
Siemens: Symbia S and Symbia T systems
CAN 001-2020
SPECT-CT system
Model: 8717741, 8717733, 10275007, 10275008, 10275009, 10275010
MHRA reference: 2020/008/027/601/003
Sysmex: Sysmex Automated Blood Coagulation Analyzer
August 2020
Coagulation
Model: CN-6000, CN-3000, CS-5100, CS-2000i, CS-2100i, CS-2400, CS-2500, CS-1600, CS-1300, CA-510, CA-520, CA-530, CA-540, CA-550, CA-560, CA-620, CA-650, CA-660, CA-1500, CA-7000, CA-8000
MHRA reference: 2020/009/002/487/017
Ventana Medical Systems (Roche): Benchmark Ultra Stainer Module
18 August 2020
IVDs, cytopathology & histopathology
Model: 05342716001
MHRA reference: 2020/009/001/291/003