Field Safety Notice: 31 December 2018 to 4 January 2019

List of field safety notices (FSNs) from medical device manufacturers from 31 December 2018 to 4 January 2019

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

Beckman Coulter

24 December 2018

IVDs, haematology

MHRA reference: 2018/012/024/601/022

Beckman Coulter: DxA 5000

24 December 2018

IVDs, haematology

MHRA reference: 2018/012/024/601/021

Beckman Coulter: DxA 5000

20 December 2018

IVDs, clinical chemistry

MHRA reference: 2018/012/024/601/019

Beckman Coulter: DxA 5000

20 December 2018

IVDs, clinical chemistry

MHRA reference: 2018/012/024/601/018

Draeger: various

December 2018

Anaesthetic & breathing, medical gas pipelines

MHRA reference: 2018/012/031/487/006

Draeger: Fabius GS/ GS premium/ MRI/ Plus/ Plus XL/ Tiro

September 2018

Anaesthetic machines & monitors

MHRA reference: 2018/011/008/291/019

Implant Direct:Interactive Precision IO Scan Adapter

December 2018

Implants, dental

MHRA reference: 2018/012/031/487/005

Philips: Xper Flex Cardio Physiomonitoring System

November 2018

Monitors, patient Model: 722458

Rev A: 9898 031 78281, 9898 031 85601, 9898 031 92101

Rev B: 9898 031 93091, 9898 031 92711, 9898 031 95721

9898 031 95731, 9898 031 971519898 031 97161

Rev C: 9898 031 98351, 9898 031 99561, 9898 032 02551

9898 032 02561, 9898 014 60361, 9898 032 04001

9898 032 04031

Rev D: 9898 031 99451,

Spareparts; 4535 642 41901, 4535 644 83321, 4535 646 21791

4535 646 75021, 4535 646 34201, 4535 646 7501

MHRA reference: 2019/001/002/487/013

Philips: Intera, Enterprise, Achieva, Achieva XT, Achieva Conversion, Panorama HFO, Ingenia, Smartpath to dStream, Multiva, Prodiva, MR-OR, MR-RT, MR-Linac and MR-Marlin MR systems.

December 2018

Magnetic resonance, equipment & accessories

Model: 781069, 781070, 781072, 781073, 781074, 781076, 781078, 781101, 781102, 781103, 781104, 781105, 781106, 781107, 781108, 781145, 781150, 781153, 781160, 781170, 781171, 781172, 781173, 781174, 781175, 781176, 781177, 781178, 781195, 781196, 781240, 781250, 781253, 781260, 781261, 781262, 781270, 781271, 781277, 781278, 781283, 781295, 781296, 781341, 781342, 781343, 781344, 781345, 781346, 781347, 781350, 781356, 781357, 781358, 781359, 781377, 781396, 781437, 781438, 781439, 781474, 781477, 781479, 781483 Above systems provided with: 452213156381 FE SPEAKER MR R6.2 452213156382 FE SPEAKER MR R6.2

MHRA reference: 2018/012/031/291/001

Schulke & Mayr: octenidol® md mouthwash

18 December 2018

Dental materials

Model: 70000769 MHRA reference: 2018/012/031/291/005

Varian: Eclipse™ Treatment Planning System

17 December 2018

Radiotherapy planning and verification systems

Model: H48

MHRA reference:2018/012/031/291/006

Updates to this page

Published 7 January 2019