Field Safety Notice: 27 to 30 August 2019

List of field safety notices (FSNs) from medical device manufacturers from 27 to 30 August 2019.


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

AGFA: DR 800


X Ray, genera

MHRA reference: 2019/008/028/701/016

Becton Dickinson: BD FACSLyric™ Flow Cytometer

August 2019

IVDs, cytopathology & histopathology

Model: BD FACSLyric™ Flow Cytometer

MHRA reference: 2019/008/027/701/031

Edwards Life Sciences: IntraClude Intra-Aortic Occlusion Device

FCA 125

Vascular cannula and catheters

Model: ICF100

MHRA reference: 2019/001/021/291/001

GE: Giraffe Bedded Warmers, Panda iRes Warmers


Infant incubators

MHRA reference: 2019/008/029/487/006

Medicina: Medicina IV Syringe

22 August 2019

Injection devices

Model: IVS03

MHRA reference: 2019/008/022/601/002

Medline International: Towel, surgical

14 August 2019

Basic dressings, absorbents, swabs, procedure packs

MHRA reference: 2019/008/028/291/003

Medtronic: StealthStation Cranial 3.x Software; StealthStation S8 Cranial Software

August 2019

Surgical navigation system and accessories

MHRA reference: 2019/008/028/291/002

Pivotal Health Solutions: Epidural Positioning Device

27 August 2019

Injection devices

Model: EPD Package 2

MHRA reference: 2019/008/028/291/004

Radiometer: AQURE system

29 August 2019

IVDs, extra laboratory testing

Model: 933-599

MHRA reference: 2019/007/019/701/004

Radiometer: TCM5 FLEX/TCM5 BASIC

FAN 915-375

Diagnostic measurement and monitoring

MHRA reference: 2017/010/012/291/008

Rapid Medical:Endorectal Coils

16 August 2019

Magnetic resonance, equipment & accessories

Model: 01924, 01947, 01899, 01900, 01752

MHRA reference: 2019/008/012/701/017

Richardson Healthcare: C-Sorb

27 August 2019

Basic dressings, absorbents, swabs, procedure packs

MHRA reference: 2019/008/028/291/005

Roche: ALB2, BILT3

August 2019

IVDs, clinical chemistry

MHRA reference: 2019/008/028/701/001

Signus Medizintechnik: RABEA PEEK, zervikaler Cage gewinkelt 6x12x14mm 5°

8 August 2019

Spinal implants

MHRA reference: 2019/008/012/228/015

Published 2 September 2019