Field Safety Notices - 30 March to 3 April 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 30 March to 3 April 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

AVANOS: CORFLO* PEG Kit with ENFit® Connector

27 March 2020

Feeding systems and tubes

MHRA reference: 2020/003/030/487/008

Biomet (Zimmer): Comprehensive Reverse Shoulder System

31 March 2020

Joint prosthesis, shoulder

MHRA reference: 2020/004/001/487/001

Biomet (Zimmer): Coonrad-Morrey Pin and Bushing Kit SML/REG E1

26 March 2020

Joint prosthesis, elbow

MHRA reference: 2020/003/024/291/007

Biomet (Zimmer): Comprehensive

2 April 2020

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2020/004/002/291/008

Blue Belt Technologies (Smith+Nephew): NAVIO Soft Tissue Protector

3 March 2020

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2020/003/024/291/010

Boston Scientific: GreenLight 0010-2400 MoXy Laser Fiber

March 2020

Therapy, lasers

MHRA reference: 2020/003/031/487/001

Bucher Leichtbau: EMS Stretcher PN: 1354100,

00927/19 2019-02-01

Stretchers

MHRA reference: 2019/002/012/487/035

Canon Medical Systems: Interventional Angiography System

30 Match 2020

X ray, fluoroscopy systems

Model: INFX-8000C & INFX-8000V

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

Inpeco A3600: Accelerator A3600

23 March 2020

IVDs, clinical chemistry

MHRA reference: 2020/003/031/291/002

Inpeco Aptio: Aptio Automation

23 March 2020

IVDs, clinical chemistry

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

Inpeco: FlexLab

23 March 2020

IVDs, clinical chemistry

MHRA reference: 2020/003/031/291/001

Intervascular: Hemashield Gold – Hemashield Platinum

25 March 2020

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2020/003/024/291/006

Mercado Medic: Real 9000 plus

S02461

Supportive seating

MHRA reference: 2020/003/027/487/002

Merit Medical: PreludeSYNC DISTAL

1721504-03/06/20-001R

Surgical equipment, tourniquets

MHRA reference: 2020/003/030/487/002

Natus: Aircal

CAPA004808

Surgical equipment, miscellaneous

Model: 8-04-13310, 8-04-13321, 8-04-13322

MHRA reference: 2020/003/030/487/001

NuVasive

1 April 2020

Spinal implants

Model: MAGEC 1, MAGEC 1.5, MAGEC 2, MAGEC 2B (or MAGEC X)

MHRA reference: 2020/003/010/479/001

Ortivus: CoroNet MobiMed

13 February 2020

Monitors, patient

MHRA reference: 2020/004/001/291/001

SenTec AG: Sentec Digital Monitored System

2 May 2019

Monitors, patient

MHRA reference: 2019/005/007/487/002

Siemens: Atellica CH 930 Analyzer

February 2020

IVDs, clinical chemistry

MHRA reference: 2020/003/030/601/002

Synaptive Medical: ClearCanvas RIS/PACS

March 2020

Picture archiving and communication system (PACS)

Model: Version 3.0 and higher

MHRA reference: 2020/003/027/291/002

Updates to this page

Published 6 April 2020