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