Field safety notices - 21 to 25 December 2015

List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 December 2015


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.

See more information on what an FSN is and why it’s important.

Latest FSNs

View the latest FSNs

Acist Medical: BT2000 Manifold Kit, CPT2000 Manifold Kit

21 December 2015

Media Injectors

Model: BT2000, CPT2000

MHRA reference: 2015/012/022/291/025

alamedics: ala®purple

21 December 2015

Implants, Non active, Intraocular

Model: ala®purple

MHRA reference: 2015/012/021/701/018

Ambu A/S: 408 300 000

9 December 2015

Laryngeal mask airway

Model: Ambu® AuraGain™ Size #3

MHRA reference: 2015/012/010/181/002

Bayer Medical Care: MEDRAD IntegoTM PET Source Administration Sets

8 December 2015

Infusion & transfusion, administration sets

MHRA reference: 2015/012/010/292/018

Becton Dickinson: FMC7 FITC

17 December 2015

IVDs, cytopathology & histopathology

Model: 332786

MHRA reference: 2015/012/023/601/001

Brainlab: iPlan RT Image (below v.4.1.2)

7 September 2015

Radiotherapy planning and verification systems

Model: BrainSCAN (end-of-life)

MHRA reference: 2015/010/006/292/019


05 November 2015

Radiotherapy planning and verification systems

Model: Brain Metastases, Adaptive Hybrid Surgery Analysis

MHRA reference: 2015/011/020/292/016

Cardiac Science

December 2015

Defibrillators, Non implantable

Model: PN 9131-001

MHRA reference: 2015/012/021/292/015

Coloplast A/S: Vortek - Single Loop Ureteral Stent

22 December 2015

Implants, Non active, Non vascular stents

MHRA reference: 2015/012/022/701/038

Cook Ireland Ltd: Zilver® 518RX Vascular Stent

17 December 2015

Implants, Non active, peripheral vascular stents

Model: see FSN

MHRA reference: 2015/012/024/701/001

Depuy Synthes: Spine Cable System

18 December 2015

Surgical Instruments, Implant

Model: Spine Cable System; 321.131

MHRA reference: 2015/012/021/291/020

Fukuda Densh: DYNASCOPE

11 December 2015

Monitors, Patient

Model: DS 8100

MHRA reference: 2015/012/018/601/006

Maquet: Cardiosave Hybrid/Rescue IABP

17 December 2015

Cardiac assist pumps

Model: 0998-00-0800-XX & 0998-UC-0800-XX

MHRA reference: 2015/012/022/292/006

Radiometer: AQURE system

FAN 915-345

IVDs, extra laboratory testing

Model: Flexlink (933-504)

MHRA reference: 2015/012/022/291/001

Siemens Healthcare: INNOVANCE PFA P2Y

December 2015


MHRA reference: 2015/012/023/292/010

Stryker Trauma GmbH: sterile pack. Guide wires, K-Wires , Metaizeau pin

22 December 2015

Osteosynthesis, skeletal pins, wires & staples

Model: sterile pack. Guide wires, K-Wires, Metaizeau pin

MHRA reference: 2015/012/022/291/026

Vygon: NS2 6FR DEHP Free PVC tube 75CM XRO

22 December 2015

Feeding systems and tubes

Model: 0363062

MHRA reference: 2015/012/022/601/007

Zimmer: NexGen Precoat/Option Stemmed Tibia

18 December 2015

Joint prosthesis, knee

Model: NexGen Precoat/Option Stemmed Tibia

MHRA reference: 2015/012/021/291/006

Zimmer: Zimmer Universal Locking System

21 December 2015

Osteosynthesis, bone plates

MHRA reference: 2015/012/021/292/023

Published 29 December 2015