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