Field Safety Notice - 27 November to 1 December 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.

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

Allergan Limited: NATRELLE® Re-Sterilizable Breast Implant Sizers

17 November 2017

Implants, breast

MHRA reference: 2017/011/016/291/010

Beckman Coulter Ireland Inc: System Calibrator

28 November 2017

IVDs, clinical chemistry

MHRA reference: 2017/011/030/601/008

Brainlab AG: Brainlab Navigation System Spine & Trauma 3D

16 November 2017

Surgical navigation system

Model: 19154-03 / 19154-04

MHRA reference: 2017/011/028/701/011

Cepheid

15 September 2017

IVDs, viral microbiology

Model: Xpert® EV

MHRA reference: 2017/009/025/701/002

Charter Kontron Ltd:Menntor x7

29 November 2017

Monitors, patient

MHRA reference: 2017/010/008/401/001

Cook Group Incorporated: Cook Vital-Port® Vascular Access System

29 November 2017

Vascular cannula and catheters

MHRA reference: 2017/011/029/291/026

Elekta Ltd: Digital Accelerator

December 2017

Radiotherapy

MHRA reference: 2017/011/030/291/011

Gyrus ACMI, Inc

24 November 2017

Surgical power tools

Model: Gyrus ACMI Round Cutting Burr - Variable Exposure

MHRA reference: 2017/010/005/601/007

Horiba Medical: HORIBA ABX

25 October 2017

IVDs, haematology

Model: Pentra 400 / Pentra C400

MHRA reference: 2017/011/009/601/002

Kimal plc: Altius

22 November 2017

Vascular cannula and catheters

Model: K2CS and K2CV Adult range with exception of 7 lumen catheters

MHRA reference: 2017/011/022/601/002

Leica Biosystems Newcastle Ltd: Bond™ Aspirating Probe Cleaning System

26 October 2017

IVDs, cytopayhology & histopathology

Model: CS9100

MHRA reference: 2017/011/028/601/002

Limacorporate S.p.A: SMR graft cutter

22 November 2017

Surgical instruments, non-articulated cutting

Model: SMR graft cutter - 9013.75.443

MHRA reference: 2017/011/024/228/003

MAKO Surgical (Stryker): PKA & THA software application for RIO System

15 September 2017

Surgical navigation system

MHRA reference: 2017/009/013/701/011

Philips: Sonalleve MR-HIFU Release 3.5 with Direct Skin Cooling (DISC) device 781360, 781361, 781362

November 2017

Ultrasound, therapy

MHRA reference: 2017/011/028/291/016

RaySearch Laboratories AB: RayStation

17 November 2017

Radiotherapy planning and verification systems

Model: 3.5, 4.0, 4.5, 4.7, 5, 6, RayPlan 1 (RayStation 4.9) & RayPlan 2 (RayStation 6)

MHRA reference: 2017/011/027/701/008

Starkey Hearing Technologies: Starkey

2017

Disabled peoples' aids

Model: EM2108

MHRA reference: 2017/008/030/291/021

Thermofisher Scientific: Thermo Scientific Oxoid Brilliance Staph 24 Agar

30 November 2017

IVDs, Bacteriology

MHRA reference: 2017/011/030/601/003

Published 5 December 2017