Field Safety Notices - 4 July - 8 July 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 4 - 8 July 2016
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
View the latest FSNs
AB SCIEX Pte: 3200MD series and 4500MD series
16 June 2016
IVDs, clinical chemistry
Model: API 3200MD™ LC/MS/MS System, 3200MD QTRAP® LC/MS/MS System, Triple Quad™ 4500MD LC/MS/MS System, QTRAP® 4500MD LC/MS/MS System
MHRA reference: 2016/007/001/291/007
Depuy Synthes: Guide Sleeve, yellow
08 June 2016
Orthopaedic surgical instruments - measuring tools
Model: 03.037.017
MHRA reference: 2016/007/001/291/003
Gas Control Equipment: Gas Cylinders
160557 Gas cylinders Model: Resus Regulator RR-PI.0-BS 11F1-RR O2
MHRA reference: 2016/006/030/601/010
Howmedica Osteonics: Exeter Rasp
05 July 2016
Surgical instruments, non-articulated cutting
Model: Exeter Rasp 0930-9-003
MHRA reference: 2016/006/027/291/019
Lemaitre Vascular: Over-the-Wire Embolectomy Catheters
2 November 2015
Vascular cannula and catheters
Model: Over-the-Wire Embolectomy Catheters1651-XX
MHRA reference: 2016/004/018/299/001
Lemaitre Vascular:LeMaitre Single Lumen Embolectomy Catheter
2 November 2015
Vascular cannula and catheters
Model: LeMaitre Single Lumen Embolectomy Catheter 1601-XX, 1801-XX
MHRA reference: 2016/004/015/299/015
NeoCoil: NeoCoil
17 June 2016
Magnetic resonance, equipment & accessories
Model: 3T Flex SPEEDER, Large
MHRA reference: 2016/006/024/601/009
Newdeal: ACHILLON Minimally Invasive Achilles tendon Suture System
23 June 2016
Sutures
MHRA reference: 2016/006/023/291/012
Philips: DuraDiagnost
22 June 2016
X Ray, digital acquisition systems
Model: DuraDiagnost 712211, 712214
MHRA reference: 2016/007/005/291/012
RaySearch Laboratories: RayStation
01 July 2016
Radiotherapy planning and verification systems
Model: RayStation 3.0, 3.5, 4.0, 4.5, 4.7, 5.0
MHRA reference: 2016/007/004/291/012
Stryker: Pneumo Sure High Flow Insufflator
May 2016
Surgical equipment, minimal access
Model: Pneumo Sure High Flow Insufflator 620-040-600, 620-040-601, 620-040-602, 620-040-604, 620-040-610, 620-040-611, 620-040-613, 620-040-614, 2400069
MHRA reference: 2016/005/011/299/006
Synovis Life Technologies: Vascu-Guard Peripheral Vascular Patch
July 2016
Implants, non-active, surgical vascular grafts & patches
MHRA reference: 2016/007/006/291/011
Vision RT: AlignRT
24 June 2016
Radiotherapy
MHRA reference: 2016/007/001/601/008