Field safety notices - 19 to 23 October 2015

List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2015.

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

Biomet 3i: provide protection caps

September 2015

Implants, dental

MHRA reference: 2015/010/019/291/014

Biosense Webster: CARTOSOUND module

21 September 2015

Surgical navigation system

MHRA reference: 2015/010/008/292/013

Boston Scientific: RotaWire Elite™ guidewire and wireClip™ torquer guidewire manipulation device

October 2015

Vascular cannula/catheter accessories

Model: H802233301 (5-pack, outer package UPN), H802233300 (single unit, inner package UPN)

MHRA reference: 2015/010/015/292/015

Depuy Synthes: Spine-USS ll rod introduction pliers 388.508

14 October 2015

Surgical instruments, implant

MHRA reference: 2015/010/021/291/003

immucor GTI Diagnostics: LIFECODES LifeScreen Deluxe (LMX)

19 October 2015

IVDs, immunology

MHRA reference: 2015/010/020/292/014

IMPAC Medical Systems

FCA-IMS-0010

Radiotherapy planning and verification

Model: Monaco

MHRA reference: 2015/010/015/181/003

Spacelabs Healthcare: cardiac event recorder

25 September 2015

ECG

Model: CardioCall VS20, VS20x4, ST80, ST80x4

MHRA reference: 2015/010/016/051/002

William A. Cook: Sydney IVF PVP

10 October 2015

Laboratory equipment associated with IVF, cells, tissues

Model: K-SIPV-200-5

MHRA reference: 2015/010/008/292/004

VBM Medizintechnik: cuff controller and Shiley pressure control

7 September 2015

Airway devices

MHRA reference: 2015/009/028/081/009

Zimmer Biomet: Taperloc femoral hip

21 October 2015

Joint prosthesis, hip

MHRA reference: 2015/010/022/181/004

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