Field Safety Notice - 03 April to 07 April 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 03-07 April 2017

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 Vascular:Absorb Bioresorbable Vascular Scaffold System

31 March 2017

Implants, non active, coronary stents

Model: See FSN

MHRA reference: 2017/003/029/299/010

Bracco Injeneering: CT Exprès 3D Temperature Maintainer Model

25 March 2017

Media injectors

Model: 650207 (CT Exprès 3D)

MHRA reference: 2017/004/003/601/006

CareFusion: Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump; Asena™ GS, GH, CC, TIVA, PK Syringe Pumps

March 2017

Infusion systems

Model: 8001, 8002, 8003, 8004, 8005, 8007; 8001, 8002, 8003, 8004, 8005

MHRA reference: 2017/003/031/299/034

Gryphus Diagnostics:OSOM BVBLUE Test

3 April 2017

IVDs, bacteriology

MHRA reference: 2017/004/005/701/013

Helena Laboratories: Cascade Abrazo c-ACT-LR

05 April 2017

Coagulation

MHRA reference: 2017/003/013/299/025

Medtronic: Newport HT70 Ventilators

April 2017

Lung ventilators

MHRA reference: 2017/004/005/601/009

Mizuho: Wilson Frame Pads

28 March 2017

Pressure relief cushions

Model: 5319-37

MHRA reference: 2017/003/030/601/014

SALVIA: elisa 600, elisa 800, elisa 800 VIT

6 March 2017

Lung ventilators

MHRA reference: 2017/003/031/701/004

Natus: neoBLUE LED Phototherapy System; 010066, 010068, 010069, 010070

March 2017

Therapy, infant phototherapy

MHRA reference: 2017/004/005/701/004

NIHON KOHDEN: Life Scope G9

April 2017

Monitors, patient

Model: Life Scope G9; CSM-1901

MHRA reference: 2017/004/003/701/012

ORGENTEC: ORG 247 Anti-Intrinsic Factor

29 November 2016

IVDs, immunology

MHRA reference: 2017/003/031/701/018

Philips: Allura Xper Systems, CV20 Systems and UNIQ systems

09 March 2017

X-ray, fluoroscopy systems

Model: The following systems are only affected if a Laird chiller is installed (11NC: 98960021599):

MHRA reference: 2017/003/031/299/024

SSI Diagnostica: Immuview® S. pneumoniae and L. pneumophila urinary

24 March 2017

IVDs, bacteriology

MHRA reference: 2017/003/031/299/026

St. Jude Medical: Merlin@Home Transmitter

3 April 2017

Implants, active, defibrillators

Model: EX1150, EX1150W, EX1100, and EX1100W

MHRA reference: 2017/004/003/701/020

Smith & Nephew: Radial Osteotome Blade

31 March 2017

Surgical instruments, non articulated cutting

MHRA reference: 2017/003/031/701/020

Siemens: Dimension TNI, DimnesioV DIGXN, E2, FERR, PRL, TSH

March 2017

IVDs, clinical chemistry

Model: Dimension TNI, DimnesioV DIGXN, E2, FERR, PRL, TSH

MHRA reference: 2017/004/003/601/004

aap Implantate: Annex A: Item 6 Information on the medical device

15 March 2017

Osteosynthesis, bone screws

MHRA reference: 2017/004/004/701/013

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