Field Safety Notice - 29 January - 2 February 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 29 January to 2 February 2018

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

Beckman Coulter: COULTER EPICS Series Flow Cytometers

17 January 2018

IVDs, haematology

MHRA reference: 2018/001/025/601/005

BIOMERIEUX: Etest® Polymyxin B PO 0.064-1024 B30

29 January 2018

IVDs, bacteriology

MHRA reference: 2018/001/030/000/003

Biomet: ACE Trochanteric Nail (ATN) System

31 January 2018

Osteosynthesis, nails intramedullary

Model: ACE Trochanteric Nail (ATN) System

MHRA reference: 2018/002/001/000/009

GB UK (Enteral): CAREFEED FEEDING AND DRAINAGE TUBE

24 January 2018

Feeding systems and tubes

Model: CAREFEED FEEDING AND DRAINAGE TUBE CF01.14.092ISOSAF

MHRA reference: 2018/001/026/701/019

GE: CARESCAPE Central Station

FMI 36124

Monitors, patient

Model: Carescape central unit

MHRA reference: 2018/001/024/228/006

IM Services B.V.: Semen collection container 125 ml with label

January 2018

Laboratory equipment associated with IVF, cells, tissues

MHRA reference: 2018/001/025/000/005

Implantcast GmbH: 2M insert 15° for MUTARS® RS cup and LUMiC® TiN

28 December 2017

Joint prosthesis, hip

Model: 02423839; 02424244; 02424448; 02424652

MHRA reference: 2017/012/001/291/032

MAKO Surgical Corp (Stryker): MAKO RIO Spare Part Ethernet-Fiber Optic Converter

January 2018

Surgical navigation system

MHRA reference: 2018/001/025/701/013

Medistim ASA: VeriQ, MiraQ

18 January 2018

Ultrasound, imaging

MHRA reference: 2018/001/015/291/001

Medtronic: BI70000028230 O-arm® 1000 Surgical Imaging System (3rd edition)

January 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/001/031/000/022

OCULUS Optikgeräte: Pentacam AXL

15 November 2017

Optical, ophthalmic instruments & equipment

Model: 70100

MHRA reference: 2018/001/012/291/001

Orthofix: DOUBLE ROW FOOTPLATES, TL-HEX STERILE, ALL SIZES

23 January 2018

Osteosynthesis, external fixators

MHRA reference: 2018/001/026/000/018

Pacific Medico:PMH 7000 Series

19 January 2018

Breathing system components

Model: PMH 7000 Series

MHRA reference: 2018/002/001/291/011

Philips: IQon Spectral CT

11 January 2018

Computed tomography

Model: 728332

MHRA reference: 2018/001/025/000/002

Philips: CPR Meter w/Q-CPR® Technology

19 January 2018

Defibrillators, non-implantable

Model: 861444, 861332, 861322, 989803139951, 989803162401, 989803149941

MHRA reference: 2018/001/029/000/014

Philips: Avent smart ear thermometer and ear thermometer

26 January 2018

Diagnostic measurement and monitoring

Model: SCH740 and DL8740

MHRA reference: 2018/001/029/000/009

RaySearch Laboratories: RayStation

26 January 2018

Radiotherapy planning and verification systems

Model: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)

MHRA reference: 2018/002/001/000/008

Siemens: ARTIS one

12 December 2017

X ray, fluoroscopy systems

Model: 10848600

MHRA reference: 2018/001/030/601/004

Smiths Medical: CADD® Medication Cassette Reservoir

January 2018

Infusion systems

Model: 21-7001-24; 21-7002-24; 21-7100-24

MHRA reference: 2017/010/012/701/035

Published 6 February 2018