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


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


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


Picture archiving and communication

MHRA reference: 2018/008/002/291/061

Elekta: MOSAIQ

August 2018


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

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

Published 7 August 2018