Field safety notices - 29 June to 3 July 2015

List of field safety notices (FSNs) from medical device manufacturers from 29 June to 3 July 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.

Latest FSNs

View the latest FSNs

Animas Corporation

29 May 2015

Infusion systems

Model: Animas insulin pumps

MHRA reference: 2012/010/019/081/023

Baxter Healthcare: Flo Gard 6201 compatible blood set

June 2015

Infusion and transfusion, administration sets

MHRA reference: 2015/006/029/291/010

Biosense Webster: NMARQ circular irrigated catheter

24 June 2015

Therapy, tissue ablation

MHRA reference: 2015/006/022/291/017

Ecolab: Sterile 60ml EU BD syringe multi-packs

12 June 2015

Injection devices

Model: 3058460

MHRA reference: 2015/006/016/291/003

GE Medical Systems LLC: Precision 500D - Advantx Legacy/Legacy-D

FMI 10902

X-Ray, fluoroscopy systems

MHRA reference: 2015/007/001/291/005

Hoffrichter: Hoffrichter Trend II, point, Vector et

30 June 2015

Lung ventilators

Model: Home CPAP unit

MHRA reference: 2015/006/002/291/007

Maquet Cardiopulmonary AG: heater cooler unit HCU 40 high voltage

23 June 2015

Infusion and transfusion, heart lung circuits

Model: 70104.4054

MHRA reference: 2015/006/026/051/004

Medline Industries: charging base for surgical clipper

June 2015

Surgical equipment, miscellaneous

MHRA reference: 2015/006/025/291/006

Medical Components: MEDCOMP HEMO-CATH LT and HEMO-CATH ST; JET Flow

12 June 2015

Vascular cannula and catheters

Model: See P.S.A. June 12 Medcomp; Jet –Medical

MHRA reference: 2015/007/001/291/002

St Jude Medical: Nanostim™ leadless pacemaker

02 July 2015

Implants, active, pacemakers

Model: S1DLCP

MHRA reference: 2015/002/020/131/004

TORNIER: Aequalis IM nail targeting jig

29 June 2015

Surgical instruments, implant

MHRA reference: 2015/006/030/291/001

Roche Diagnostics: cobas b 123 POC systems

23 June 2015

IVDs, extra laboratory testing

Model: blood gas analyser

MHRA reference: 2015/007/001/701/004

Volcano: S5 and Core family with SW version 3.3/3.4

30 June 2015

Ultrasound, imaging

MHRA reference: 2015/007/001/291/003

Zethon: Forceps

03 July 2015

Surgical, diathermy

MHRA reference: 2015/006/030/291/002

Zimmer Biomet UK: AGC dual articular 2000 knee femoral component

29 June 2015

Joint prosthesis, knee

MHRA reference: 2015/007/001/291/018

Published 3 July 2015