Field Safety Notice - 23 to 27 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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
3M: 3M™ Bair Hugger™ Temperature Monitoring Sensor
19 October 2017
Diagnostic measurement and monitoring
MHRA reference: 2017/010/023/291/041
A&E Medical Corporation: MYO/Punch, A&E Surgical Punch
20 October 2017
Surgical instruments, articulated cutting
Model: 080-271, 080-351, 080-401, 080-403, 080-451, 080-481, 080-501
MHRA reference: 2017/010/026/291/005
Aesculap: COLUMBUS REV FEMUR SPACER DISTAL F5 15MM
24 October 2017
Joint prosthesis, knee
MHRA reference: 2017/010/025/701/031
Biomet
24 October 2017
Joint prosthesis, shoulder
Model: Comprehensive Reverse Versa-Dial Glenosphere Provisional Instruments and Comprehensive Humeral Head Provisional Instrument
MHRA reference: 2017/010/025/000/004
HOYA: PENTAX Endscopes (multiple types)
October 2017
Endoscopes, flexible
Model: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970
MHRA reference:2017/010/023/291/031
Hamamatsu Photonics: NanoZoomer-SQ
25 October 2017
IVDs, cytopathology & histopathology
Model: C13140-21
MHRA reference: 2017/010/026/000/003
Integrum AB: Abutment Screw Diamond
19 October 2017
Osteosynthesis, bone screws
Model: Abutment Screw Diamond 1191, 1192
MHRA reference: 2017/010/023/291/054
Liko AB: Carraige S65 W Single Hook
MOD1267
Hoists and slings
Model: 3036011
MHRA reference: 2017/010 /012/291/013
LivaNova: PERFUSION TUBING SYSTEMS
05 October 2017
Infusion & transfusion, heart lung circuits
MHRA reference: 2017/010/011/291/008
Maxter Catheters: Nasogastric Feeding Tubes for neonates & pediatric
17 October 2017
Feeding systems and tubes
Model: 503xx 503Txx 503TLXX 505xx 506XX 507xx 507LXX 508xx
MHRA reference: 2017/010/023/701/012
Sysmex: FLUOROCELL PLT
28 August 2017
IVDs, haematology
MHRA reference: 2017/009/019/291/001
Thermo Fisher Scientific: enGen Laboratory Automation & Automation solutions
8 September 2016
IVDs, clinical chemistry
MHRA reference: 2016/009/012/601/002
Thermofisher Scientific: Oxoid Mueller-Hinton Agar Broth
19 October 2017
IVDs, bacteriology
Model: CM0405B
MHRA reference: 2017/010/020/601/004
Xograph Healthcare: Airway Bougie
12 June 2017
Airway devices
MHRA reference: 2017/006/006/291/036
Updates to this page
Last updated 23 November 2017 + show all updates
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Added FSN for Xograph
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First published.