Field Safety Notices - 27 July - 31 July 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 27 July to 31 July 2020

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 FSNs

View the latest FSNs - (For webupdates: this is a new link for each week)

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

AD-TECH: Surgical drill guide, reusable

10 September 2019

Surgical power tools

MHRA reference: 2020/005/016/601/002

Biohit Oyj: BIOHIT ColonView

22 July 2020

IVDs, clinical chemistry

MHRA reference: 2020/007/029/487/003

Cardinal Health: Protexis Latex Micro Surgical Gloves

29 July 2020

Gloves, surgical & examination

MHRA reference: 2020/007/028/701/046

Getinge: Datascope Intra-Aortic Ballon Catheters (IABs) 28 July 2020 Cardiac assist pumps MHRA reference: 2021/001/008/701/013

Globus Medical: ALTERA

22 July 2020

Spinal implants

Model: 1124.1011, 1124.1012, 1124.1013, 1124.1015, 1124.1032, 1124.1033, 1124.1035, 1124.1111, 1124.1112, 1124.1113, 1124.1115, 1124.1132, 1124.1133, 1124.1135, 1124.1211, 1124.1212, 1124.1213, 1124.1215, 1124.1232, 1124.1233, 1124.1235, 1124.1111S

MHRA reference: 2020/007/030/701/007

ITH icoserve technology for healthcare: syngo.share view diagnostic

10 July 2020

Picture archiving and communication system (PACS)

Model: 11250008

MHRA reference: 2020/007/029/601/004

Philips Healthcare: HeartStart MRx Defibrillator/Monitor

09 July 2020

Defibrillators, non implantable

MHRA reference: 2020/007/029/487/008

QIAGEN: QIAstat-Dx Respiratory SARS-CoV-2 Panel

16 July 2020

IVDs, SARS-CoV-2 PCR Test

MHRA reference: 2020/007/028/291/002

Roche Diagnostics: Elecsys CA 19-9

July 2020

IVDs, clinical chemistry

MHRA reference: 2020/007/028/291/001

Siemens: Cios Spin & Cios Alpha

July 2020

X ray, fluoroscopy systems

MHRA reference: 2020/007/028/601/002

Siemens Healthcare: syngo.via RT Image Suite, feature synthetic CT

June 2020

Computed tomography

MHRA reference: 2020/007/024/601/005

Steripack: Syringe NaCl 0,9% Luer Lock 10 ml (5ml fill) *S

31 March 2020

Vascular cannula/catheter accessories

MHRA reference: 2020/002/013/291/004

Thermo Fisher Scientific: Remel

22 July 2020

IVDs, bacteriology

Model: R30165501

MHRA reference: 2020/007/023/601/006

Trinity Biotech:Uni-Gold™ S. pneumoniae

27 June 2020

IVDs, bacteriology

Model: 1204420

MHRA reference: 2020/006/030/291/009

WEINMANN Medical Technology: MEDUMAT Standard 2

July 2020

Lung ventilators

Model: 28710

MHRA reference: 2020/007/029/487/004

LeMaitre Vascular: LeMaitre Over the Wire Embolectomy Catheter

30 July 2020

Vascular cannula and catheters

Model: 1651-84, 1654-88

MHRA reference: 2020/003/025/487/009

Updates to this page

Published 3 August 2020