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

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