Field Safety Notice - 12 to 16 February 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 February 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 FSNs

View the latest FSNs

3M Health Care: 3M™ Surgical Clipper Professional

09 February 2018

Surgical Equipment, Miscellaneous

MHRA reference: 2018/002/014/478/013

Beckman Coulter: AQUIOS CL Flow Cytometer System

05 February 2018

IVDs, haematology

MHRA reference: 2018/002/012/601/002

BERCHTOLD GmbH & Co. KG (Stryker): ChromoView Monitor carrier arm

February 2018

Lamps & Lights

Model: CT 0604004, CT 0604104, CT 0605004, CT 0605104, CT 0606104

MHRA reference: 2018/002/008/701/013

Chalice Medical:Paragon

05 February 2018

Heart Lung Machines

Model: Oxygenators

MHRA reference: 2018/002/005/601/002

Covidien llc: Barrx™ 360 Express RFA Balloon Catheter

February 2018

Therapy Tissue Ablation

MHRA reference: 2018/002/015/291/012

FUJIFILM: FUJIFILM 7000 Video Processor


Endoscopes, televisual systems

Model: VP-7000

MHRA reference: 2018/002/014/478/010

GCMedica Enterprise (Wuxi): Uterine Aspiration Tube

07 February 2018

Surgical Equipment, Miscellaneous

MHRA reference: 2018/002/008/478/001

GE Healthcare Integrated IT Solutions: Centricity Universal Viewer


Picture Archiving And Communication System (PACS)

MHRA reference: 2018/002/012/291/009

Illumina: MiSeqDx Cystic Fibrosis 139-Variant Assay (2 Run)

13 February 2018

IVD, genetic testing

Model: PN 15036580

MHRA reference: 2018/002/013/601/006

Life Technologies Corporation: Fetal Hemoglobin Monoclonal Antibody (HBF-1), FITC

05 February 2018

IVDs, Blood Transfusion

MHRA reference: 2018/002/015/291/011

MAKO Surgical (Stryker): Restoris® MCK Onlay Insert Extractor

February 2018

Orthopaedic Surgical instruments - Insertion/extraction tools

MHRA reference: 2018/001/026/701/013

Medtronic:Bio-Cal Temperature Controller

February 2018

Blood/fluid warming systems

Model: 370, 370I

MHRA reference: 2018/002/012/478/004

Micromed SpA: CAR POLE (component of BQ and BRAIN QUICK series)

07 February 2018

Monitors, patient

Model: 400.041.0000

MHRA reference: 2018/002/012/291/008

NxStage Medical: NxStage PureFlow SL SAK

29 January 2018

Dialysis, Haemodialysis

Model: SAK-303, SAK-304, SAK-30

MHRA reference: 2018/002/012/291/007

NxStage Medical: NxStage PureFlow SL SAK

29 January 2018

Dialysis, haemodialysis

Model: NxStage PureFlow SL SAK

MHRA reference: 2018/002/014/291/007

Omixon Biocomputing: Omixon HLA Twin CE

24 January 2018

IVD, genetic testing

MHRA reference: 2018/001/029/228/004

Philips Medical Systems (Andover): Philips SureSigns VSi / SureSigns VS2+

January 2018

Monitors, Patient

Model: SureSigns VSi: 863275, 863276, 863277

SureSigns VS2+: 863278, 863279

MHRA reference: 2018/002/012/478/003

XO Care A/S: Dental unit XO 4

26 October 2017

Dental Appliances / Instruments

Model: X04

MHRA reference: 2018/001/031/228/009

Published 19 February 2018