Field Safety Notices - 5 - 9 September 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 5 - 9 September 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

Abbott Medical Optics: Refer to Section 8

August 2016

Implants, non-active, intraocular

Model: various models

MHRA reference: 2016/008/031/701/012

Alba Bioscience: ALBAcyte® A2 Cells REAGENT RED CELLS

31 August 2016

IVDs, blood transfusion

MHRA reference: 2016/008/031/601/012

Animas Corporation: Animas Insulin Pumps

19 September 2016

Infusion systems

MHRA reference: 2016/009/002/291/020

Biocartis: Idylla™ KRAS Mutation Test

1 September 2016

IVD, genetic testing

MHRA reference: 2016/009/002/701/006

DFS-Diamon: solder and wire for laser welding for dental prosthesis

2 September 2016

Dental materials

MHRA reference: 2016/009/002/291/021

Ecolab: Klerpack BD Syringe Multi-Pack

2 September 2016

Injection devices

Model: 3038080, 3038090, 3038110, 3038120, 3039820, 3039830, 3039840, 3039850, 3039870, 3039880, 3039920, 3039940, 3040080, 3040100, 3039910, 3040000, 3058710, 3038100, 3058720, 3040070, 3040060, 3039980, 3039960, 3039890, 3039900, 3040120

MHRA reference: 2016/009/006/701/005

Etac: Molift Air 205 & 3000

6 July 2016

Hoists and slings

MHRA reference: 2016/006/029/291/016

Fresenius: CATSmart 9005751

5 September 2016

Infusion & transfusion, autologous

MHRA reference: 2016/009/006/299/014

GE healthcare: SIGNA Creator/ SIGNA Explore

FMI 67921

Magnetic resonance, equipment & accessories

MHRA reference: 2016/009/005/701/017

GE Medical: MAGiC application running on some GEHC MR systems M70012RM

FMI 60903

Magnetic resonance, equipment & accessories

Model: MAGiC application running on some GEHC MR systems

MHRA reference: 2016/009/005/701/018

Getinge Lancer: ED-FLOW AER, ED-FLOW SD AER

16 August 2016

Cssd wash/clean/drying equipment

Model: 01280004, 01280010, 01280012, 01280014, 01280015.

MHRA reference: 2016/009/005/299/011

Merit Medical: Drip Chamber

1721504-08/11/16-003-R

Vascular cannula and catheters

MHRA reference: 2016/008/029/701/009

Philips: Brilliance BR64 Ingenuity CT Ingenuity Core Ingenuity Core128

26 August 2016

Computed tomography

Model: Brilliance BR64 (728231) Ingenuity Core (728321) Ingenuity Core128 (728323) Ingenuity CT (728326)

MHRA reference: 2016/009/008/299/006

Radiometer: ABL90 FLEX and ABL90 PLUS

FAN 915-353

IVDs, Extra Laboratory Testing

MHRA reference: 2016/009/007/701/008

Randox: IgE

28 July 2016

IVDs, immunology

Model: Calibrators

MHRA reference: 2016/009/005/601/003

Robinson Healthcare: Instrapac

8 September 2016

Dental syringes and needles

MHRA reference: 2016/009/007/701/007

Shenzhen: Dryline II Water Trap

August 2016

Anaesthetic machines & monitors

MHRA reference: 2016/008/030/291/023

Siemens: Dimension & Dimension Vista IRON Flex reagen

September 2016

IVDs, clinical chemistry

Model: Dimension & Dimension Vista IRON Flex reagent. DF85 Dimension Iron K3085 Dimension Vista Iron

MHRA reference: 2016/009/008/601/008

Siemens: RAPIDPoint 400, 450 Measurement Cartridge

September 2016

IVDs, extra laboratory testing

MHRA reference: 2016/009/005/601/005

Spacelabs Healthcare: UVSL Command Module

1 July 2016

Monitors, patient

Model: UVSL Command Module 91496

MHRA reference: 2016/007/012/131/003

Teleflex Medical: EZIO Manual Driver

1 September 2016

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference: 2016/009/005/299/008

Unisurge International: Formula Procedure Packs

ASCF2016-09-006

Surgical, diathermy

Model: F300073 / F300079 / F300088 / F300096 / F300106 / F300197 / F301031 / F301200 / F301404 / F600486 / F700038 / F700092

MHRA reference: 2016/009/006/601/004

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