Field Safety Notice - 13 to 17 November 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 November 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
Beckman Coulter: DxH 500
14 November 2017
IVDs, haematology
Model: DxH 500; Not applicable
MHRA reference: 2017/011/015/601/003
Blatchford: Kato Seat
October 2017
Supportive seating
MHRA reference: 2017/002/027/401/016
Fresenius: Freka Intestinal Tubes ENFit
15 November 2017
Feeding systems and tubes
Model: 7755646 and 7755647
MHRA reference: 2017/011/001/291/001
GE Healthcare: Millennium VG, Discovery VH, VariCam
GEHC Ref 40874
Nuclear medicine, gamma camera systems & accessories
MHRA reference: 2017/011/014/228/001
Inspiration Healthcare: CosyCrib NeoNatal Nursing System
11 September 2017
Heating, patient, electrical pads & blankets
Model: CCS001 / CCS002
MHRA reference: 2017/009/005/601/005
Medtronic: SynchroMed® II Implantable Drug Pumps
November 2017
Implants, active, infusion pumps
Model: 8637-20, 8637-40
MHRA reference: 2017/011/016/291/018
PFM Medical: Nit-Occlud Implantation Sheath
19 July 2017
Vascular cannula and catheters
Model: 004580, 204580, 404580, 604580, 804580, 904580
MHRA reference: 2017/011/009/228/015
Philips: Brilliance iCT, Brilliance 64, Ingenuity Core, Ingenuity Core 128
1 November 2017
Computed tomography
Model: 728306, 728231, 728321, 728323
MHRA reference: 2017/011/016/291/012
SORG: Mio, Mio Move, Kika and Vector
24 October 2017
Wheelchairs, manual
MHRA reference: 2017/011/013/228/020
Siemens: SOMATOM Force, SOMATOM Definition AS, Edge, Flash
November 2017
Computed tomography
Model: 7740769, 8098027, 10430603, 10590000, 10742326
MHRA reference: 2017/011/013/601/009
Stryker: Stryker Slap Hammer, Non Threaded Impactor, Head Impactor
10 November 2017
Orthopaedic surgical instruments - insertion/extraction tools
Model: 6541-4-803, 2101-0130, 4842-2000
MHRA reference: 2017/011/010/601/013
Thermofisher Scientific: ThermoScientific Remel BactiStaph Latex Kits
9 November 2017
IVDs, bacteriology
Model: R21143 / R21144
MHRA reference: 2017/011/010/601/016
Zimmer Biomet
09 November 2017
Joint prosthesis, knee
MHRA reference: 2017/011/013/228/018
Zimmer Biomet
13 November 2017
Bone cement and tools
Model: Bone Cement
MHRA reference: 2017/011/015/291/035
Zimmer Biomet: Specific Hip and Trauma instruments
27 September 2017
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2017/010/003/701/010