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
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Brainlab: ExacTrac Dynamic
8 September 2020
Radiotherapy planning and verification systems
Model: 20910-01
MHRA reference:
Drive Devilbiss: Universal bed rails
30 June 2020
Beds and accessories
MHRA reference:
GE Healthcare Medical Systems: Various models affected � see FSN
GEHC Ref# 60968
Magnetic resonance, equipment & accessories
MHRA reference:
Leica: BOND Enzyme Pretreatment kit
21 September 2020
IVDs, cytopathology & histopathology
MHRA reference:
Maquet - Getinge: Blood Monitoring Unit BMU 40
18 September 2020
Diagnostic measurement and monitoring
Model: 70104.0852
MHRA reference:
Olympus: Intestinal Videoscope Olympus
21 September 2020
Endoscopes, flexible
Model: POWERSPIRAL (PSF-1)
MHRA reference:
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:
Siemens (Shenzhen): ARTIS one
September 2020
X Ray, fluoroscopy systems
Model: 10848600
MHRA reference:
Siemens: UROSKOP OMNIA and UROSKOP OMNIA MAX
XP024/20/S
X Ray, fluoroscopy systems
Model: 10094910 and 10762473
MHRA reference:
Siemens: Artis icono and Artis pheno
September 2020
X Ray, fluoroscopy systems
Model: see enclosure
MHRA reference:
Smiths Medical: Medfusion
17 August 2020
Infusion systems
Model: Medfusion 3500 and Medfusion 4000
MHRA reference:
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:
Tornier: Inspyre� Implant
23 September 2020
Joint prosthesis, shoulder
Model: Interpositional Shoulder Implant
MHRA reference:
W.L. Gore & Associates: GORE® TAG® Conformable Thoracic Stent Graft
21 September 2020
Implants, non-active, endoprostheses for aortic aneurysms
MHRA reference: