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

View the 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

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.