Field Safety Notices - 4 to 8 May 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 4 to 8 May 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.
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FSNs before this date are on the
Elekta: Accelerator system, linear
April 2020
Radiotherapy
Model: Elekta Unity
MHRA reference:
Endologix: Br Ovation Abdominal Stent Graft System Platformand
06 May 2020
Implants, non active, endoprostheses for aortic aneurysm
Model: TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I
MHRA reference:
Eurovema Mobility: Euroflex work chairs with the Forma chassis
6.6.2-2019-47648
Wheelchairs, manual
Model: 80xxxxxx, 241-xx, 242-xx, 291-xx, 292-xx, 841-xx, 891-xx
MHRA reference:
Fluoron: F-Octane (syringe), F-Decalin (syringe)
11 April 2019
Injection devices
MHRA reference:
Ivoclar Vivadent: IPS e.max ZirCAD CER/inLab LT A1-A3 C17/5
24 April 2020
Dental materials
MHRA reference:
Radiometer: ABL800 with FlexQ
FAN 915-412
IVDs, extra laboratory testing
Model: 393-800, 393-801
MHRA reference:
Siemens Healthcare: Cios Alpha & Cios Spin
April 2020
X Ray, fluoroscopy systems
Model: See FSN
MHRA reference:
Siemens Healthcare AX035/19/S: Artis zee / Artis Q / Q.zen
April 2020
X Ray, fluoroscopy systems
MHRA reference: