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