Field Safety Notice - 30 July to 3 August
List of field safety notices (FSNs) from medical device manufacturers from 30 July to 3 August 2018
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 FSN
View the latest FSNs
Agfa Healthcare: Enterprise Imaging for Radiology
VR0000568
Picture archiving and communication system (PACS)
MHRA reference: 2018/006/020/701/003
Alcon: Alcon or Endure LuxOR™ E71 Ophthalmic Microscope; Alcon or Endure LuxOR™ E71 Q-Vue
July 2018
Surgical equipment, miscellaneous
MHRA reference: 2018/008/001/228/014
Beaver Visitec: Accu-Temp High Temperature Cautery
18 July 2018
Surgical, cautery
MHRA reference: 2018/008/001/228/007
Biometrix: Temperature Sensor Catheters
03 June 2018
Urinary catheters and accessories
MHRA reference: 2018/008/002/291/047
EOS Imaging: sterEOS Workstation
REG-2018-0001-A
Picture archiving and communication
MHRA reference: 2018/008/002/291/061
Elekta: MOSAIQ
August 2018
Radiotherapy
MHRA reference: 2018/008/002/291/048
Integra Lifesciences: Knob Assembly contained in MAYFIELD
24 July 2018
Surgical instruments, articulated holding
Model: Knob Assembly contained in MAYFIELD - A2079; A2079A; A2079E; A2600R
MHRA reference: 2018/007/017/291/024
MAKO Surgical: MAKO
July 2018
Orthopaedic surgical instruments - insertion/extraction tools
Model: Vizadisc
MHRA reference: 2018/007/030/228/013
Maquet (GETINGE): 70104.4054 HCU 40
24 July 2018
Blood/fluid warming systems
MHRA reference: 2018/008/001/228/010
Medcomp: Multiple list attached
22 February 2018
Vascular Cannula And Catheters
MHRA reference: 2018/002/028/291/010
Pennine Healthcare
31 July 2018
Injection devices
Model: BBraun Spinal Mini Pack, Pencan NRFIT 25G 88mm
MHRA reference: 2018/007/030/228/012
Siemens Healthcare: ARTIS Q & ARTIS pheno
23 July 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/007/027/601/002
Linkage Biosciences: LinkSeq HLA Typing Kits
26 July 2018
IVDs, immunology
Model: CAT-1580C, CAT-1575C
MHRA reference: 2018/007/027/601/008