Field Safety Notices - 26 - 30 September 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 - 30 September 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
Becton Dickinson: CD79b (SN8) PE
26 September 2016
IVDs, haematology
Model: 335833
MHRA reference: 2016/009/027/601/007](https://mhra.filecamp.com/public/file/2gj5-rl2sop6f
Biomet 3i
September 2016
Implants, dental
Model: Certain® Low Profile Abutment; Certain® Low Profile One-Piece Abutment; Low Profile Abutment Healing Cap; Low Profile Abutment (Hexed) Pick-Up Impression Coping; Low Profile Abutment Non-Hexed Preformance® Temporary Cylinder; Low Profile Abutment Quickbridge®; Low Profile Abutment Non-Hexed Temporary Cylinder; Low Profile Abutment (Non-Hexed) Transfer Impression Coping; Low Profile Abutment Titanium Retaining Screw
MHRA reference: 2016/009/019/701/014
Hamilton Medical: Hamilton
16 August 2016
Lung ventilators
Model: Hamilton C3
MHRA reference: 2016/009/021/601/003
IMPAC Medical Systems: Monaco RTP System
FCO 382-01-MON-005
Radiotherapy planning and verification systems
MHRA reference: 2016/009/028/701/005
Medela: Swing / Swing Maxi / Freestyle
MIR0124-16 / CFR 68775
Active Wound Management
MHRA reference: 2016/009/020/299/002
Medivance: Arctic Sun® Temperature Management System
15 September 2016
Heating, patient, electrical pads & blankets
MHRA reference: 2016/009/022/601/008
Research Instruments: EZ-Strip
28 September 2016
Laboratory equipment associated with IVF
Model: Oocyte Recovery Needle
MHRA reference: 2016/009/026/701/006
Roche: Tina-quant HbA1c Gen.2; Tina-quant HbA1c Dx Gen. 2
22 September 2016
IVDs, clinical chemistry
MHRA reference: 2016/009/026/701/007
Royal Free London NHS Foundation Trust: Horsley's Bone Wax
22 September 2016
Bone cement and tools
MHRA reference: 2016/006/013/291/009
SenTec: SenTec Digital Monitor (SDM)
15 September 2016
Diagnostic measurement and monitoring
MHRA reference: 2016/009/023/299/004
Siemens: Dimension Vista Chemistry 1 Calibrator
22 September 2016
IVDs, clinical chemistry
MHRA reference: 2016/009/022/601/006
Surgical Specialties: BioSentry™ Track Sealant System
24 September 2016
Surgical instruments, minimal access
MHRA reference: 2016/009/027/291/010
Thermo Fisher Scientific: Centrifuge module
15 September 2016
Centrifuges
Model: Centrifuge module Type 1020
MHRA reference: 2016/009/027/701/001
Zimmer: Zimmer Air Dermatome II
27 September 2016
Surgical power tools
MHRA reference: 2016/007/013/701/026