Field Safety Notice: 22 to 26 July 2019

Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 July 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

Apollo Endosurgery: BIB/Orbera365 Intragastric Balloon Systems

July 2019

Implants, non-active, gastrointestinal B-40800, B-50012

MHRA reference: 2019/007/005/601/004


04 July 2019

Infusion & transfusion, administration sets

MHRA reference: 2019/006/012/601/001

Becton Dickinson: BD Max Reagents

17 July 2019

IVDs, bacteriology

MHRA reference: 2019/007/019/701/020

Becton Dickinson: Gateway Workstation and Gateway Workstation Web Browser User Interface

July 2019

Infusion systems Model: Gateway Workstation: 80203UNS02-xx, 80203UNS03-xx and 80300UNS02-xx

MHRA reference: 2019/006/014/302/001

CooperSurgical: TransWarmer Warming Infant Transport Mattress

24 June 2019

Infant, warmers Model: 20421

MHRA reference: 2019/007/022/701/002

Edwards Life Sciences: Edwards Ultra Delivery System

FCA 141

Implants, non-active, cardiovascular heart valves 9630TF20, 9630TF23, 9630TF26, 9630TF29

MHRA reference: 2019/007/015/487/010

Electromedical Products International: Alpha Conducting Solution

09 July 2019

Therapy, electrotherapy Model: ACS, ACSR (Refill)

MHRA reference: 2019/007/009/701/017

EMED SP: RF electrosurgical unit for arthroscopy

20 May 20109

Surgical instruments, minimal access

MHRA reference: 2019/007/018/487/014

Getinge: Steam sterilizer

27 June 2019

Sterilizers, steam (Autoclaves) CPS, GE, GEB, GEC, GED, GEF, GEL, GEV, GSS67, HS66, HS44, HS55, HS69, HS71, HS81

MHRA reference: 2019/007/003/291/006

Hitachi: Cobas, C, E, Pro & 8000 Module/Analyser/Analytical Unit

July 2019

IVDs, clinical chemistry

MHRA reference: 2019/007/019/291/007

Medline: MED-SEMI RIGID Liner 3.0L

18 July 2019

Surgical suction

MHRA reference: 2019/007/022/487/026

Ortho Clinical Diagnostics: ORTHO VISION and VISION Max Analyzers

July 2019

IVDs, blood transfusion Model: 6904579 and 6904578

MHRA reference: 2019/007/019/601/007

QIAGEN: QIAsymphony SP

16 July 2019

IVDs, viral microbiology

MHRA reference: 2019/007/019/701/029

Randox: Urinalysis Control Level 2

17 July 2019

IVDs, Clinical chemistry

MHRA reference: 2019/007/019/601/006

Siemens: SOMATOM Force, Drive, Confidence

14 June 2019

Computed tomography 8098027, 10430603, 10742326, 10431700, 10590000, 10590100, 10267000

MHRA reference: 2019/007/018/601/002

Stryker: Brand

14 June 2019

Joint prosthesis, hip Model: LFIT Anatomic CoCr V40 Femoral Heads

MHRA reference: 2019/007/022/487/027

Thermo Fisher: Remel

18 July 2019

IVDs, bacteriology Model: R30855201

MHRA reference: 2019/007/019/601/008

Published 29 July 2019