Field Safety Notices - 26 - 30 September 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 26 - 30 September 2016


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

Becton Dickinson: CD79b (SN8) PE

26 September 2016

IVDs, haematology

Model: 335833

MHRA reference: 2016/009/027/601/007

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


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

Published 3 October 2016