Field safety notices - 9 to 13 February 2015

List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 February 2015.

You can see copies of this week’s field safety notices in our filecamp folder.

Cook Medical: Zenith Alpha™ Thoracic Endovascular Graft

January 2015

Device description: implants, non-active, endoprostheses for aortic aneurysms

MHRA reference: 2015/001/030/701/002

Siemens Healthcare Diagnostics: Capillary Caps

January 2015

Device description: IVDs, extra laboratory testing

MHRA reference: 2015/001/027/601/003

Smith & Nephew

5 February 2015

Device description: hip prosthesis

Model: R3 HEMI THREE HOLE Acetabular Shells

MHRA reference: 2015/002/006/081/005

Micromedics (Baxter): MIS DuploSpray Regulator

January 2015

Device description: surgical devices, non-powered

Model: 0600032, 0600123

MHRA reference: 2015/002/006/051/001

Biocompatibles UK: Bead Block (Embolic Bead)

5 February 2015

Device description: implants, non-active, embolisation products

Model: 100-300 μm and 300-500 μm

MHRA reference: 2015/002/009/081/005

Randox Laboratories:

21 January 2015

Device description: IVDs, clinical chemistry

Model: Liquid Urine Control level 2 (UC5074)

MHRA reference: 2015/002/006/601/021

SAM Medical Products: SAM Junctional Tourniquet

6 November 2014

Device description: surgical equipment, tourniquets

Model: SJT 102, SJT 112

MHRA reference: 2015/002/005/081/008

Spacelabs Healthcare

6 February 2015

Device description: monitors, patient

Model: qube Compact Monitor and Xprezzon Bedside Monitor

MHRA reference: 2015/002/009/081/017

Carl Zeiss Meditec

19 December 2014

Device description: computed tomography

Model: FORUM ; 000000-2030-682, 000000-2030-683, 000000-2082-089, 000000-2082-090

MHRA reference: 2015/001/028/071/005

Trilux Medical GmbH & Co. KG

26 January 2015

Device description: light source

Model: TRILUX Operating Lighting System AURINIO L, 120 PM std. Kard Motor Kamv HD A and related Monitor holder

MHRA reference: 2015/002/009/071/007

Teleflex

Device description: nebulizers

MHRA reference: 2015/002/009/081/010

Uresil LLC

30 January 2015

Device description: surgical devices, non-powered

Model: Thoracic Vent Procedure Tray

MHRA reference: 2015/002/009/081/012

Edwards Life Sciences: Edwards Commander Delivery System

10 February 2015

Device description: vascular cannula and catheters

Model: Edwards Commander Delivery System - 9610TF23, 9610TF26, 9610TF29

MHRA reference: 2015/002/010/081/024

Trilux Medical GmbH & Co. KG

27 January 2015

Device description: lamps and lights

Model: TRILUX Examination Light Aurinio L 50

MHRA reference: 2015/002/011/081/015

Siemens AG Medical Solutions: syngo.plaza

8 January 2015

Device description: picture archiving and communication system (PACS)

Model: Radiology PACS

MHRA reference: 2014/012/011/601/013

APELEM

11 December 2014

Device description: x-ray, general

Model: PLATINUM (APELEM), BACCARA Platinum (APELEM), PLATINUM dRF (APELEM), BACCARA Platinum dRF (APELEM) and AGIL FPO (GILAROONI)

MHRA reference: 2015/002/011/081/002

Advanced Neuromodulation: Brio Charger System and Brio Charger Accessory

6 February 2015

Device description: implants, active, stimulators, neuro

Model: 65-6788, 6721 and 3767

MHRA reference: 2015/002/011/071/003

Roche Diagnostics

9 February 2015

Device description: IVDs, viral microbiology

Model: CMV IgM

MHRA reference: 2015/002/011/701/010

Wright Medical UK: Shannon Burr XL 2.0M X 20MM

27 January 2015

Device description: surgical power tools

Model: WGSMI001

MHRA reference: 2015/002/004/601/007

Published 13 February 2015