Field Safety Notice: 21 to 26 September 2020
List of field safety notices (FSNs) from medical device manufacturers from 21 to 26 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.
Brainlab: ExacTrac Dynamic
8 September 2020
Radiotherapy planning and verification systems
Model: 20910-01
MHRA reference: 2020/009/024/487/008
Drive Devilbiss: Universal bed rails
30 June 2020
Beds and accessories
MHRA reference: 2020/006/030/601/005
GE Healthcare Medical Systems: Various models affected – see FSN
GEHC Ref# 60968
Magnetic resonance, equipment & accessories
MHRA reference: 2020/009/018/291/005
Leica: BOND Enzyme Pretreatment kit
21 September 2020
IVDs, cytopathology & histopathology
MHRA reference: 2020/009/024/601/005
Maquet - Getinge: Blood Monitoring Unit BMU 40
18 September 2020
Diagnostic measurement and monitoring
Model: 70104.0852
MHRA reference: 2020/009/021/487/001
Olympus: Intestinal Videoscope Olympus
21 September 2020
Endoscopes, flexible
Model: POWERSPIRAL (PSF-1)
MHRA reference: 2020/009/010/291/002
Philips: Switched/Switchless Internal Paddles
4 September 2020
Implants, active, defibrillator leads
Model: Switched M4741A, M4742A, M4743A, M4744A
Switchless M1741A, M1742A, M1743A, M1744A (Instructions for use)
MHRA reference: 2020/009/024/487/003
Siemens (Shenzhen): ARTIS one
September 2020
X Ray, fluoroscopy systems
Model: 10848600
MHRA reference: 2020/009/021/601/006
Siemens: UROSKOP OMNIA and UROSKOP OMNIA MAX
XP024/20/S
X Ray, fluoroscopy systems
Model: 10094910 and 10762473
MHRA reference: 2020/009/021/601/005
Siemens: Artis icono and Artis pheno
September 2020
X Ray, fluoroscopy systems
Model: see enclosure
MHRA reference: 2020/009/021/601/004
Smiths Medical: Medfusion
17 August 2020
Infusion systems
Model: Medfusion 3500 and Medfusion 4000
MHRA reference: 2020/008/024/291/001
Steripack: Syringe 10 ml with 0,9% sodium chloride (An update to FSN 20 -24 July 2020)
23 September 2020
Vascular cannula/catheter accessories
MHRA reference: 2020/009/003/291/005
Tornier: Inspyre™ Implant
23 September 2020
Joint prosthesis, shoulder
Model: Interpositional Shoulder Implant
MHRA reference: 2020/009/023/487/008
W.L. Gore & Associates: GORE® TAG® Conformable Thoracic Stent Graft
21 September 2020
Implants, non-active, endoprostheses for aortic aneurysms
MHRA reference: 2020/009/011/487/005