Field Safety Notices - 12 - 16 September 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 - 16 September 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
Blackrock Microsystems: NeuroPort Biopotential Signal Processing System
31 August 2016
Monitors, patient
Model: 5703, 5747, 5748, 5749
MHRA reference: 2016/009/009/701/010
Boston Scientific: Lotus™ Valve System
5 August 2016
Implants, non-active, cardiovascular heart valves Model: H749LTV230, H749LTV250, H749LTV270
MHRA reference: 2016/008/005/299/010
Ecolab: Klerpack BD Syringe Multi-Pac
12 September 2016
Hypodermic syringe
Model: 3038080, 3038090, 3038110, 3038120, 3039820, 3039830, 3039840, 3039850, 3039870, 3039880, 3039920, 3039940, 3040080, 3040100, 3039910, 3040000, 3058710, 3038100, 3058720, 3040070, 3040060, 3039980, 3039960, 3039890, 3039900, 3040120
MHRA reference: 2016/009/006/701/005
Implant Direct: Replant 5.0mmD Abutment Assy 15 deg Angled
12 July 2016
Implants, dental
Model: 6050-52-60
MHRA reference: 2016/009/015/601/007
Leonhard Lang: multifunction defibrillation electrode
7 September 2016
Defibrillators, non-implantable
Model: DF29N
MHRA reference: 2016/009/008/299/010
Maquet: Accessory Adapter
9 September 2016
Operating table
Model: 600525A0
MHRA reference: 2016/009/009/701/007
Philips Medical Systems: MobileDiagnost wDR Rel. 1 (defined Serial No) and MobileDiagnost wDR Rel. 2
30 August 2016
X-ray, digital acquisition systems
Model: 712001/712002
MHRA reference:2016/009/014/291/007
Roche: Urine strips. See Attachment
6 September 2016
IVDs, clinical chemistry
MHRA reference: 2016/009/009/701/008
Toshiba Medical: XARIO 100, XARIO 200
12 September 2016
Ultrasound, imaging
Model: TUS-X100; TUS-X200
MHRA reference: 2016/008/031/291/011
Wescott Medical
12 September 2016
Surgical equipment, miscellaneous
Model: WEFLOW2, WEFLOW3 and WEFLOW3F
MHRA reference:2016/009/013/601/004
Wright Medical Technology: DARCO® PIA Plate
8 September 2016
Osteosynthesis, bone plates
Model: DARCO® PIA Plate DCS2802006
MHRA reference: 2016/009/007/701/012
Last updated 26 September 2016 + show all updates
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Sofradim Production September 2016 has been updated in latest list of FSNs
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First published.