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
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