Field Safety Notice - 5 to 9 February 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 February 2018

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

Aesculap (B BRAUN): STRAUSS PENIS CLAMP 130MM

1 February 2018

Surgical instruments, articulated holding

STRAUSS PENIS CLAMP 130MM EF401R

MHRA reference: 2018/002/001/701/017

Boston Scientific: EMBLEM™ S-ICD Programmer

September 2017

Implants, active, defibrillators

Model: 3200

MHRA reference: 2017/001/010/299/013

Brainlab: ExacTrac

25 January 2018

Radiotherapy

MHRA reference: 2018/002/007/291/009

Carl Zeiss Meditec AG

05 February 2018

Implants, non-active, intraocular

Model: 611P 19.5D CT Lucia

MHRA reference: 2018/002/002/000/011

Harvest Healthcare

25 January 2018

Mattresses - active/passive and overlays

Model: mattress pumps

MHRA reference: 2017/011/015/291/041

Hitachi

January 2018

Magnetic resonance, equipment & accessories

Model: OASIS

MHRA reference: 2018/002/006/000/002

Intersurgical (Updated Version)

09 January 2018

Resuscitators

Model: BVM Manual Resuscitation Systems

MHRA reference: 2017/012/022/291/023

Inova Diagnostics: QUANTA Lyser® 240

26 January 2018

IVDs, clinical chemistry

Model: GS0242

MHRA reference: 2018/002/005/601/008

Olympus Corporation: URF-V2/URF-V2R flex

08 February 2018

Endoscopes, flexible

Model: URF-V2/URF-V2R

MHRA reference: 2018/001/030/000/008

Olympus Medical Systems: URETERO-RENOFIBERSCOPE - URF-P6/URF-P6R

08 February 2018

Endoscopes, flexible

MHRA reference: 2018/001/030/000/007

Richardson Healthcare: Plus Dressing Towel

31 January 2018

Basic dressings, absorbents, swabs, procedure packs

Model: 958008

MHRA reference: 2018/001/031/601/011

Smith & Nephew: LEGION HK DISTAL FEMORAL WEDGE SZ5 5MM

01 February 2018

Joint prosthesis, knee

MHRA reference: 2018/002/005/701/018

Synergy Health UK Limited: Attached list has name, lot, mfd & expiry dates

12 September 2017

Central sterilisation services materials

MHRA reference: 2017/009/021/291/015

Vircell: BORRELIA VIRCLIA® IgG MONOTEST

26 January 2018

IVDs, bacteriology

MHRA reference: 2018/002/005/291/019

Published 12 February 2018