Field Safety Notices - 9 January - 13 January 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 January 2017


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

Advanced Sterilization Products

3 January 2017

Cssd wash/clean/drying equipment

MHRA reference: 2017/001/010/701/008

Bausch + Lomb: LaserEdge Knives

11 January 2017

Surgical Instruments, non-articulated cutting

Model: E7600

MHRA reference: 2017/001/012/701/003

Bausch + Lomb: LazerEdge Knifes

27 December 2016

Surgical Instruments, non-articulated cutting

Model: E7600

MHRA reference: 2016/012/028/291/033

CooperSurgical: Quinn's Advantage Medium with Hepes

14 November 2016

Laboratory equipment associated with IVF, cells, tissues

Model: ART-l023 100 ml

MHRA reference: 2016/011/018/299/004

Covidien: Devon™ Light Glove

9 January 2017

Lamps and lights

MHRA reference: 2017/001/006/701/015

Endolologix: AFX EndoVascular AAA System

4 January 2017

Implants, non-active, endoprostheses for aortic aneurysms

Model: AFX devices with Strata graft material and AFX2 devices in 28 mm Main Body and/or 20 mm Iliac Limbs (see overview of affected models in Attachments 1 and 2 of the FSN letter)

MHRA reference: 2017/001/005/601/013

Global Components Medical: GCM

10 October 2016

Infusion & transfusion, administration sets

Model: GCM-235

MHRA reference: 2015/010/008/601/005

Immuno-Mycologics: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)

4 January 2017

IVDs, Viral microbiology

Model: CR2003

MHRA reference: 2017/001/006/701/014

IMPAC Medical: Monaco ® RTP System

December 2016

Radiotherapy planning and verification systems

MHRA reference: 2017/001/006/701/006

Mölnlycke Health Care: ProcedurePak® trays containing "Swab Gauze XRD 30x30 18ply"

5 January 2017

Surgical devices, non-powered

MHRA reference: 2017/001/006/701/002

Olympus: URF-P6/URF-P6R Uretero-Reno Fiberscope

6 January 2017

Endoscopes, flexible

Model: URF-P6/URF-P6R

MHRA reference: 2017/001/005/701/007

Siemens: ADVIA Centaur Progesterone; Dimension Vista LOCI Progesterone, IMMULITE/IMMULITE 1000 Progesterone; IMMULITE 2000 Progesterone

4 January 2017

IVDs, clinical chemistry

Model: ADVIA Centaur/Dimension Vista/Immulit

MHRA reference: 2017/001/009/601/002

Villa Sistemi Medicali: Apollo / DRF/ EZ / EZ DRF; Clinodigit EVO, JunoDRF

27 December 2016

X Ray, fluoroscopy systems

MHRA reference: 2016/012/028/701/006

Zimmer Biomet: Oxford Fixed Lateral Bearing Size F Right

9 December 2016

Joint prosthesis, knee

MHRA reference: 2016/012/019/701/039

Published 16 January 2017