Field Safety Notice - 10 September to 14 September
List of field safety notices (FSNs) from medical device manufacturers from 10 September to 14 September
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: Accelerator APS
07 September 2018
IVDs, clinical chemistry
MHRA reference: 2018/009/011/701/003
Alere: Alere Triage® NT-proBNP Test
31 August 2018
IVDs, clinical chemistry
MHRA reference: 2018/009/003/701/015
Arthrex: DrillSaw Sports 400 System Li-Ion Battery Housing
R517_UK
Surgical power tools
Model: AR-400UBH
MHRA reference: 2018/009/007/701/021
Axis-Shield: Alere NT-proBNP for ARCHITECT Controls
076308
IVDs, clinical chemistry
Model: FRBNP200
MHRA reference: 2018/009/007/701/018
Bio-Rad: Pastorex Meningitis R4 reagent
22 August 2018
IVDs, bacteriology
MHRA reference: 2018/009/013/291/008
Boston Scientific: LATITUDE™ Programmer model 3300
September 2018
Implants, active, pacemakers
Model: Model 3300
MHRA reference: 2018/009/012/291/012
Boston Scientific: ACCOLADE™ & ACCOLADE™ MRI PROPONENT™ & PROPONENT™ MRI
ESSENTIO™ & ESSENTIO™ MRI VISIONIST™ X4VALITUDE™ X4
September 2018
Implants, active, pacemakers
MHRA reference: 2018/009/012/291/001
Guangzhou Wondfo Biotech: Clear & Simple Digital Pregnancy Test
01 September 2018
IVDs, extra laboratory testing
MHRA reference: 2018/009/007/291/020
Intelligence Artificielle Applications SA: SIRscan discs Amoxicillin 2µg + clavulinic acid 1µg
12 July 2018
IVDs, Bacteriology
MHRA reference: 2018/009/013/291/009
Leica: Slide Labeler (Zebra) used with BOND-MAX/BOND-III
13 September 2018
IVDs, cytopathology & histopathology
Model: Zebra TLP3842 and Zebra GX460t
MHRA reference: 2018/009/006/601/008
Maquet: Flow-c
07 September 2018
Anaesthetic machines & monitors
MHRA reference: 2018/009/007/291/021
Maquet (Getinge): SoKINOX / SERViNO
MCC/18/007/IU
Lung ventilators
Model: 6694550 / 6881700
MHRA reference: 2018/009/013/291/024
Ovesco: AWC-Additional Working Channel
13 August 2018
Endoscopes, flexible
Model: 200.57.01 / 200.57.04
MHRA reference: 2018/009/012/291/024
Sysmex: Automated Hematology Analyzer XN series
R1802734/YBO 201807
IVDs, haematology
Model: XN-10, XN-20
MHRA reference: 2018/008/024/291/017