Field Safety Notices - 31 July - 07 August 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 31 July to 07 August 2020.

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

View a list of FSNs published since January 2020

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

CareFusion (BD): BD Alaris™ System Infusion Pump

3 August 2020

Infusion systems

MHRA reference: 2020/008/003/291/004

Handicare AB: SwiftHook

20 December 2019

Hoists and slings

Model: 70200008

MHRA reference: 2019/012/024/487/001

LivaNova: Dual collapser – size S/M

29 July 2020

Implants, non active, cardiovascular heart valves

MHRA reference: 2020/007/027/291/001

Luminex Corporation: Amplification Well Temperature Verification Fixture (FA-0005-01), Elution Well Temperature Verification Fixture (FA-0006-01), Sample Well Temperature Verification Fixture (FA-0007-01), Hybridization Cartridge Temperature Verification Fixture (FA-0008-01), Z-Axis Calibration Gauge (FA-0013-01), VERIGENE® Reader Alignment Slide (FA-0014-01)

24 July 2020

IVDs, bacteriology

MHRA reference: 2020/008/004/291/003

Maquet Cardiopulmonary (GETINGE): Product name listed in Annex 1 and comment section

31 July 2020

Heart lung machines

Model: 701072163, 701072162, 701046405, 701043290, 701043291, 701043292, 701043296, 701043299, 701051696, 701051697, 701054401

MHRA reference: 2020/008/005/487/004

Randox Laboratories: Randox Ammonia

30 July 2020

IVDs, clinical chemistry

MHRA reference: 2020/007/030/601/007

Roche Diagnostics: Elecsys Anti-TPO

July 2020

IVDs, Immunology

MHRA reference: 2020/007/031/291/005

Rocket Medical: FBS Fetal Blood Sampling Kit

INT COMP-127

Storage & collection devices

MHRA reference: 2020/007/027/601/002

Siemens Healthcare: Artis zee & Artis Q

July 2020

X ray, fluoroscopy systems

MHRA reference: 2020/008/003/601/008

Siemens Healthcare GmbH: Sola, Vida; 11291455, 11060815

June 2020

Magnetic resonance, equipment & accessories

MHRA reference: 2020/008/003/291/007

Smith & Nephew Inc: GENESIS II Tibial Base Plate

22 July 2020

Joint prosthesis, knee

MHRA reference: 2020/007/031/291/001

Smith and Nephew Inc (Endoscopy): SUTUREFIX ULTRA 1.7MM DRILL (S)

24 June 2020

Surgical power tools

MHRA reference: 2020/007/031/291/004

Smith & Nephew: T-FIX RCG Sterile Drill

24 June 2020

Surgical power tools

MHRA reference: 2020/007/031/291/003

Smith & Nephew Orthopaedics AG: POLARSTEM COLLAR Reamer Guide

22 July 2020

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2020/007/031/291/002

Welch Allyn: Various Welch Allyn Patient Cables and Lead Sets

30 July 2020

ECG

Model: 9293-046-XX, 9293-047-XX, 9293-017-XX, 9293-026-XX 9293-061-XX, 9293-033-XX, 9293-034-XX, (X can be any combination of 0-9)

MHRA reference: 2020/003/019/487/001

Williams Medical Supplies: Paxxon Disposable Forceps

19 June 2020

Surgical instruments, articulated holding

Model: D2601

MHRA reference: 2020/007/016/601/004

Updates to this page

Published 10 August 2020