Field safety notices - 25 to 29 January 2016

List of field safety notices (FSNs) from medical device manufacturers from 25 January to 29 January 2016.


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

Abbott Ireland Diagnostics Division: ARCHITECT STAT High Sensitive Troponin-I

21 January 2016

IVDs, clinical chemistry

MHRA reference: 2016/001/022/701/003

Accuray Incorporated: CyberKnife robotic radiosurgery system

22 January 2016


Model: CyberKnife G4, G3, VSI

MHRA reference: 2016/001/022/701/006

Agfa HealthCare: Digital radiography X-ray system


X-ray, digital acquisition systems

Model: DX-D 100

MHRA reference: 2016/001/022/299/006

Arrow International: Super Arrow-Flex percutaneous sheath introducer set

21 January 2016

Vascular cannula and catheters

MHRA reference: 2016/001/022/291/009

Baxter: Sterile water for irrigation, 1000 ml

January 2016

Surgical equipment, miscellaneous

MHRA reference: 2016/001/025/299/018

Bio-Rad Medical Diagnostics: Anti-Jka (JK1)

25 January 2016

IVDs, blood transfusion

Model: 808176

MHRA reference: 2016/001/025/701/005

Mast Group Ltd: Mast Cephalexin 16ug 96 well pre-poured susceptibility test plate


IVDs, Bacteriology

Model: MPM-CFX16

MHRA reference: 2016/001/028/601/004

Phadia: EliaA SmD well

28 December 2015

IVDs, Immunology

Model: Smith antibody (anti-Sm) IVD, kit fluorescent immunoassa

MHRA reference: 2015/012/030/601/001

Philips Respironics: Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC


Lung ventilators

MHRA reference: 2016/001/022/299/005

Physio-Control Operations: Lifepak 15 monitor/defibrillator

January 2016

Defibrillators, non-implantable

MHRA reference: 2015/003/016/401/015

Sekisui Diagnostics: Sekure acetaminophen L3K assay

22 January 2016.

IVDs, clinical chemistry

MHRA reference: 2016/001/025/299/011

Zimmer: LPS-Flex precoat femoral A-L

January 2016

Joint prosthesis, knee MHRA reference: 2016/001/022/291/002

Published 1 February 2016