Field Safety Notices - 2 to 6 March 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 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

C-RAD Positioning: C-RAD c4D software

28 January 2020

Radiotherapy planning and verification systems

MHRA reference: 2020/003/005/291/004

Cristalens: concerning software

20 November 2019

Implants, non-active, intraocular

MHRA reference: 2020/002/027/291/001

Dermosciences: Mela Peel kit, Mela Peel Forte kit / Dermaceutic

BR-2019-03- 16 January 2020

Substances for topical application (non-pharmaceutical)

Activa Peel bottle 12 ml

MHRA reference: 2020/002/012/291/010

Dermosciences: TCA 12, TCA 15, TCA 18, TCA 20

16 January 2020

Substances for topical application (non-pharmaceutical)

Model: 30 ml bottle

MHRA reference: 2020/002/012/291/011

Fast Track Diagnostics: Siemens Material Number 10921784/ 10921785

February 2020

IVDs, bacteriology

MHRA reference: 2020/003/005/291/011

Horiba: Yumizen G DDi 2

21 February 2020

Coagulation

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

Karl Storz: Low pressure tube, for the central CO2 gas supply

26 February 2020

Surgical equipment, minimal access

UI001, UI002 und UI003

MHRA reference: 2020/003/002/291/001

Medisoft: Medisoft Ophthalmology

26 February 2020

Optical, ophthalmic instruments & equipment

MHRA reference: 2020/002/027/601/004

Medisoft: Medisoft Ophthalmology

27 February 2020

Optical, ophthalmic instruments & equipment

MHRA reference: 2020/002/028/601/003

Molnlycke: Molnlycke Procedure Trays

20 February 2020

Surgical devices, non-powered

MHRA reference: 2020/002/021/291/005

Omixon Biocomputing: Omixon HLA TWIN CE

05 March 2020

IVDs, Immunology

SW1

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

Pennine Healthcare: SYS-5212

05 March 2020

Surgical equipment, miscellaneous

Yankauer Sucker Set, 2.0m, 5mm, Neuroflex - SYS-5212

MHRA reference: 2020/003/004/601/003

Philips: TRx4851A 2.4 GHz IntelliVue Tele TRX or TRx4841A 1.4 GHz IntelliVue Tele TRX When used in combination with the Patient Information Center (PIC) iX

19 March 2020

Monitors, patient

Model: 862231 or 862439 when used with 866389, 866390

MHRA reference: 2020/002/027/291/014

R82: Chest support for Rabbit/Rabbit Up/Mustang

04 March 2020

Supportive seating

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

RaySearch Laboratories: RayStation

03 March 2020

Radiotherapy planning and verification systems

RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9

MHRA reference: 2020/003/005/291/001

Siemens: N Latex CDT Kit

February 2020

IVDs, clinical chemistry

MHRA reference: 2020/002/028/291/003

ViCentra B.V: Kaleido Insulin Cartridge

04 March 2020

Infusion systems

MHRA reference: 2020/003/004/601/001

Zimmer: Anatomical Shoulder Trial Humeral PE-Insert 40-0

28 February 2020

Joint prosthesis, shoulder

Model: 01.04239.730

MHRA reference: 2020/002/028/291/006

Updates to this page

Published 9 March 2020