Field Safety Notice - 29 October to 02 November
List of field safety notices (FSNs) from medical device manufacturers from 29 October to 02 November
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
Abbott Medical: St. Jude Medical Infinity™ DBS System (8-Channel)
01 October 2018
Implants, active, stimulators, neuro
MHRA reference: 2018/010/011/291/003
Alere (Abbott Medical): Alere BinaxNOW Legionella with the Alere Reader
November 2018
IVDs, bacteriology
MHRA reference: 2018/011/001/487/003
AngioDynamics: XCELA PASV 4F SL 55CM
16 October 2018
Vascular cannula and catheters
Model: H965557110
MHRA reference: 2018/010/029/291/016
Bard: BARD® ePTFE Small Beading Vascular Graft Products
FA2018-12
Implants, non-active, peripheral vascular stents
MHRA reference: 2018/010/016/291/010
Biomet: Compress Devices and Instruments
31 October 2018
Orthopaedic implant intercalary component
MHRA reference: 2018/011/001/487/027
Ekamed: ekamove 30° Seitenlagerungssystem
11657/18
Mattresses - active/passive and overlays
MHRA reference: 2018/010/022/291/010
GE Medical: B20, B40, Patient Monitor B125 / B105
GEHC Ref# 36132
Monitors, patient
MHRA reference: 2018/010/030/291/002
Linkage Biosciences: LinkSeq HLA ABCDRDQA1DQB1/ABCDRDQDP+/SABR/DRDQDP
24 October 2018
Instrumentation/ platform
Model: LinkSeq HLA
MHRA reference: 2018/010/030/487/009
Magstim Company: Magstim HORIZON E-z Arm
25 October 2018
Therapy, nerve stimulators
Model: 5162-00
MHRA reference: 2018/010/029/291/059
Pennine Healthcare: BBraun Spinal Mini Pack, Pencan NRFIT 25G 88mm
01 November 2018
Injection devices
MHRA reference: 2018/007/030/228/012
Siemens: ARTIS zee
18 October 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/010/029/601/005
Siemens: Artis zee biplane and Artis Q biplane
10 October 2018
Fluoroscopy system
MHRA reference: 2018/010/029/601/004
Stryker: Spirit Plus and Spirit Select Siderail entrapment
31 October 2018
Beds and accessories
Model: 5600 - 07613327284553; 5700 - 07613327284546
5700 - 07613327284546
MHRA reference: 2018/010/022/701/015
Philips Medical: Brilliance 6 (Air), Brilliance 10 (Air), Brilliance 16 (Air), Brilliance 16 (Power), Brilliance 40,
Brilliance 64
18 October 2018
Computed Tomography
MHRA reference: 2018/010/025/487/013