Field Safety Notices - 6 - 10 June 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 June 2016
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
Baxter: Vivia System
26 May 2016
Dialysis, haemodialysis
Model: 5H51101
MHRA reference: 2016/005/027/299/005
Corin: TaperFit
6 June 2016
Joint prosthesis, hip
Model: 588.3801
MHRA reference: 2016/006/006/601/007
Dentsply: Implant Pick-Up EV 5.4 Short
3 June 2016
Implants, dental
MHRA reference: 2016/006/009/701/004
Gas Control Equipment: MARS II
1 June 2016
Resuscitators
Model: MARS II 0715212, 0715216, 0715217, 0715226
MHRA reference: 2016/006/003/601/005
GE Medical: Revolution CT
FMI 25469
Computed tomography
MHRA reference: 2016/005/009/291/006
GE Medical:Revolution CT
FMI25468
Computed tomography
MHRA reference: 2016/006/003/299/003
Impac Medical Systems: MOSAIQ
FCA-IMS-0014
Radiotherapy
Model: Versions 2.62 and higher with the IQ Scripts license enabled
MHRA reference: 2016/006/010/299/001
Milestone: VACUUM BAG DU LARGE and VACUUM BAG 5U SMALL
26 May 2016
IVDs, specimen receptacles
MHRA reference:2016/006/007/299/019
Maquet Critical Care: FLOW-i
1 June 2016
Anaesthetic machines & monitors Model: 6677200 FLOW-i C20, 6677300 FLOW-i C30, 6677400 FLOW-i C40
MHRA reference: 2016/006/001/299/021
Philips: Brilliance 64, Ingenuity Core, Ingenuity Core128
8 April 2016
Computed tomography
Model: 728231, 728321, 728323
MHRA reference: 2016/004/026/291/008
Smith & Nephew: various
6 June 2016
Joint prosthesis, hip
MHRA reference: 2016/006/006/299/026
Stryker:Target Detachable Coils
3 June 2016
Implants, non-active, embolisation products
MHRA reference: 2016/006/008/701/017
STERIS: V-PRO® 1, V-PRO® 1 Plus, and V-PRO maX® Sterilizer
30 May 2016
Cssd wash/clean/drying equipment
MHRA reference: 2016/006/003/291/004
Tosoh: ST AIA-PACK iE2 and ST AIA-PACK hsE2
8 June 2016
IVDs, clinical chemistry
MHRA reference: 2016/006/006/299/011
Ultradent products: InterGuard
29 December 2015
Dental appliances / instruments
MHRA reference: 2015/012/029/701/001
Wieland Dental + Technik: Zenostar MT Color Liquids
May 2016
Dental materials
MHRA reference: 2016/005/024/291/001