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
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