Field Safety Notices - 12 - 16 September 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 12 - 16 September 2016

From:
Medicines and Healthcare products Regulatory Agency
Published
19 September 2016
Last updated
26 September 2016 — See all updates
Message type:
Field safety notice
Issued:
19 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

Updates to this page

Published 19 September 2016
Last updated 26 September 2016 show all updates

  1. Sofradim Production September 2016 has been updated in latest list of FSNs

  2. First published.

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