Field Safety Notices - 26 - 30 December 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 26-30 December 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

Ascensia Diabetes Care Holdings: Glucofacts Deluxe

FAO 43

IVDs, self / home testing

MHRA reference: 2016/012/021/701/024

Blatchford Products:Orion3

December 2016

Prostheses

MHRA reference: 2016/012/012/291/035

Philips: DuraDiagnost , DuraDiagnost Compact

09 December 2016

X Ray, digital acquisition systems

Model: 712210, 712211, 712212, 712213

MHRA reference: 2016/012/021/291/014

Roche: Multiplate® Analyzer

21 December 2016

Coagulation

Model: 06675069001

MHRA reference: 2016/012/023/701/016

Siemens: Mammomat Inspiration

UI XP040/16/S (CSAN) & UI XP041/16/S (FSCA)

Mammography

Model: 10140000 (only systems with Biopsy functionality)

MHRA reference: 2016/012/029/601/002

Siemens: N Latex HCY

December 2016

IVDs, clinical chemistry

MHRA reference: 2016/012/021/701/017

Siemens: Biograph mCT and Biograph mCT Flow

MI516/16/S

Nuclear medicine, gamma camera systems & accessories

Model: 10248668, 10248669, 10248670, 10248671, 10248672,

MHRA reference: 2016/012/021/601/002

Siemens: Ammonia Flex® reagent cartridge

December 2016

IVDs, clinical chemistry

Model: Dimensionn & Vista®

MHRA reference: 2016/012/022/601/005

STERIS: AMSCO 3053 & AMSCO 5053 Washer/Disinfector

22 December 2016

Cssd wash/clean/drying equipment

MHRA reference: 2016/011/007/291/011

Trinity Biotech: Glucose-6 Phosphate Dehydrogenase (G-6-PDH)

19 December 2016

IVDs, clinical chemistry

MHRA reference: 2016/012/023/701/010

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