Field Safety Notices - 28 November - 2 December 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 28 November - 2 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
BioMérieux: NucliSENS®
25 November 2016
IVDs, viral microbiology
Model: NucliSENS® easyMAG® Magnetic Silica, NucliSENS® Magnetic Extraction Reagents
MHRA reference: 2016/011/028/291/005
Brasseler: Patello-Femoral Joint Milling Handpiece
30 November 2016
Surgical power tools
MHRA reference: 2016/011/030/701/013
CIM med: CIM med Bottom Mounted Height Adjustable Arm
19 September2016
Monitors, patient
Model: 431A
MHRA reference: 2016/009/021/601/008
Datex-Ohmeda: Avance CS2, Avance, Amingo
FMI 34079
Anaesthetic machines and monitors
Model: 1009-9050-000, 1009-9002-000, 1009-9013-000.
MHRA reference: 2016/011/024/299/010
FUJIFILM: FUJIFILM Flexible Duodenoscope
ECN-G1636
Endoscopes, flexible
Model: ED-530XT & ED-530XT8
MHRA reference: 2016/011/025/701/009
IMPAC Medical: MOSAIQ®
November 2016
Radiotherapy
MHRA reference: 2016/011/028/701/004
Institut Straumann: see section 8 for details
ER16-0381/SB6/2016
Surgical power tools
Model: various models
MHRA reference: 2016/011/023/701/016
Laerdal: Laerdal Compact Suction Unit (LCSU4)
21 November 2016
Suction equipment
MHRA reference: 2016/011/029/701/005
Macopharma
24 November 2016
Infusion & transfusion, blood bags Model: NPT6280LA MHRA reference: 2016/011/029/701/006
Newdeal: Forefoot 1.5 set
R-HHE117
Surgical devices, non-powered
MHRA reference: 2016/011/025/299/010
Ortho Clinical: ORTHO VISION# ® and VISION# ® Max Analyzers for BioVue
December 2016
IVDs, blood transfusion
Model: 6904579 and 6904578
MHRA reference: 2016/011/024/601/004
Randox: Glucose
24 November 2016
IVDs, clinical chemistry
Model: GL364, GL366, GL1021, GL2614, GL2623
MHRA reference: 2016/011/029/601/006
Stanmore: METS Modular Tumour System
25 November 2016
Joint prosthesis, hip
Model: various
MHRA reference: 2016/011/024/701/019
Urotech: Guidewire Semislip
29 November 2016
Vascular cannula/catheter accessories
MHRA reference: 2016/011/030/291/002
Vasorum: CELT ACD Vascular Closure Device
29 November 2016
Implants, non-active, vascular haemostasis device
Model: CELT ACD Vascular Closure Device; KCLT-05; KCLT-06
MHRA reference: 2016/011/030/701/015
Wallac: DELFIA hFSH Kit and AutoDELFIA hFSH Kit
16 November 2016
IVDs, clinical chemistry
Model: A017-201 and B017-201
MHRA reference: 2016/011/016/701/012