Field Safety Notices - 19 December - 23 December 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 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
Agfa: NX 3.0
VR0000460
Picture Archiving and Communication System (PACS)
Model: Version 8950 (software)
MHRA reference: 2016/012/020/701/013
Bedfont Scientific: NObreath
06 December 2016
Diagnostic measurement and monitoring
MHRA reference: 2016/011/029/601/005
Elekta: Oncentra External Beam
December 2016
Radiotherapy planning and verification systems
Model: 170.730
MHRA reference: 2016/012/021/701/016
Hamamatsu: NanoZoomer
2 December 2016
IVDs, cytopathology & histopathology
Model: NanoZoomer -XR(L), -SQ, -S210, -S60
MHRA reference: 2016/012/020/291/027
Medtronic: SynchroMed® II Programmable Pump, N’Vision Application Card
December 2016
Implants, active, infusion pumps
Model: 8637-20, 8637-40, 8870
MHRA reference: 2016/012/019/291/012
nal von minden: NADAL hCG Pregnancy rapid test
12 December 2016
IVDs, extra laboratory testing
MHRA reference: 2016/012/015/701/010
Richard Wolf: Guide Wire Semislip L 150CM
07 December 2016
Surgical instruments, minimal access
Model: 4111000150
MHRA reference: 2016/012/015/701/007
Philips: Ingenia MR-OR
November 2016
Magnetic resonance, equipment & accessories
Model: 781437, 781438
MHRA reference: 2016/012/021/291/012
Philips: Allura Xper Systems and Allura Integris Systems
09 December 2016
X Ray, fluoroscopy systems
Model: 72247, 722043, 722001, 722002, 722003, 722005, 722006, 722008
MHRA reference: 2016/012/021/291/020
Stanmore: METS Modular Proximal Humerus System
20 December 2016
Joint prosthesis, shoulder
Model: Humerus Integral Shaft and Stem implant component (80mm stem length)
Humerus Integral Shaft and Stem implant component (100mm stem length)
MHRA reference: 2016/012/021/291/007
Synergy Health: DETEX
16 December 2016
Basic dressings, absorbents, swabs, procedure packs
Model: 30 x 30cm, 18ply, stitched and taped, 5 Tied, Double Wrapped.
MHRA reference: 2016/012/019/701/026