Field Safety Notice - 27 November to 1 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 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
Allergan Limited: NATRELLE® Re-Sterilizable Breast Implant Sizers
17 November 2017
Implants, breast
MHRA reference: 2017/011/016/291/010
Beckman Coulter Ireland Inc: System Calibrator
28 November 2017
IVDs, clinical chemistry
MHRA reference: 2017/011/030/601/008
Brainlab AG: Brainlab Navigation System Spine & Trauma 3D
16 November 2017
Surgical navigation system
Model: 19154-03 / 19154-04
MHRA reference: 2017/011/028/701/011
Cepheid
15 September 2017
IVDs, viral microbiology
Model: Xpert® EV
MHRA reference:2017/009/025/701/002
Charter Kontron Ltd:Menntor x7
29 November 2017
Monitors, patient
MHRA reference: 2017/010/008/401/001
Cook Group Incorporated: Cook Vital-Port® Vascular Access System
29 November 2017
Vascular cannula and catheters
MHRA reference: 2017/011/029/291/026
Elekta Ltd: Digital Accelerator
December 2017
Radiotherapy
MHRA reference: 2017/011/030/291/011
Gyrus ACMI, Inc
24 November 2017
Surgical power tools
Model: Gyrus ACMI Round Cutting Burr - Variable Exposure
MHRA reference: 2017/010/005/601/007
Horiba Medical: HORIBA ABX
25 October 2017
IVDs, haematology
Model: Pentra 400 / Pentra C400
MHRA reference: 2017/011/009/601/002
Kimal plc: Altius
22 November 2017
Vascular cannula and catheters
Model: K2CS and K2CV Adult range with exception of 7 lumen catheters
MHRA reference: 2017/011/022/601/002
Leica Biosystems Newcastle Ltd: Bond™ Aspirating Probe Cleaning System
26 October 2017
IVDs, cytopayhology & histopathology
Model: CS9100
MHRA reference: 2017/011/028/601/002
Limacorporate S.p.A: SMR graft cutter
22 November 2017
Surgical instruments, non-articulated cutting
Model: SMR graft cutter - 9013.75.443
MHRA reference: 2017/011/024/228/003
MAKO Surgical (Stryker): PKA & THA software application for RIO System
15 September 2017
Surgical navigation system
MHRA reference: 2017/009/013/701/011
Philips: Sonalleve MR-HIFU Release 3.5 with Direct Skin Cooling (DISC) device 781360, 781361, 781362
November 2017
Ultrasound, therapy
MHRA reference: 2017/011/028/291/016
RaySearch Laboratories AB: RayStation
17 November 2017
Radiotherapy planning and verification systems
Model: 3.5, 4.0, 4.5, 4.7, 5, 6, RayPlan 1 (RayStation 4.9) & RayPlan 2 (RayStation 6)
MHRA reference: 2017/011/027/701/008
Starkey Hearing Technologies: Starkey
2017
Disabled peoples' aids
Model: EM2108
MHRA reference: 2017/008/030/291/021
Thermofisher Scientific: Thermo Scientific Oxoid Brilliance Staph 24 Agar
30 November 2017
IVDs, Bacteriology
MHRA reference: 2017/011/030/601/003