Field safety notices - 25 to 29 June 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 June 2018.


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

Baxter: SUPOR Syringe Filter, 0.2 Micron, 25mm

May 2018

Infusion & transfusion, administration sets

Model: 112062

MHRA reference: 2018/006/025/081/023

Intuitive Surgical: da Vinci® Xi™ EndoWrist Suction Irrigator


Endoscopes, rigid

Model: 480299-04

MHRA reference: 2018/006/015/701/010

Magellan Diagnostics: LeadcareII/Leadcare Plus

18 June 2018

IVDs, clinical chemistry

MHRA reference: 2018/006/026/081/006

Medtronic: Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™ Pacemakers

June 2018

Implants, active, pacemakers

Model: W1TR04, W4TR04

MHRA reference: 2018/006/028/081/012

Medtronic - ICD: EnTrust® and Escudo® VR/DR/AT ICDs

June 2018

Implants, active, defibrillators

MHRA reference: 2018/006/028/081/013

Microgenics (ThermoFisher): QMS Teicoplanin Calibrator

18 June 2018

IVDs, clinical chemistry

MHRA reference: 2018/006/019/701/012


22 June 2018

Endoscopes, televisual systems

Model: OTV-S200 & OTV-S300

MHRA reference: 2018/006/021/291/001

Ortho Solutions: FPS 2.7/3.5MM Depth Gauge

18 June 2018

Orthopaedic surgical instruments

Model: OS328001

MHRA reference: 2018/006/021/601/008

Radiometer: ABL800 (Update)

June 2018

IVDs, extra laboratory testing

Model: 393-800, 393-801

MHRA reference: 2018/006/020/291/002

Radiometer Medical: ABL800 Analyzer

June 2018

IVDs, extra laboratory testing

Model: ABL800 Analyzer 393-801

MHRA reference: 2018/006/025/701/020

Samsung: FSN - GC80,GC85,GC70

FSN- GC_180530-1

X Ray, digital acquisition systems

MHRA reference: 2018/005/031/701/013

Siemens Healthcare: Artis Q/Pheno systems

20 June 2018

X Ray, fluoroscopy systems

Model: Artis Q/Pheno systems and X-ray generator A100

MHRA reference: 2018/006/022/601/005

Stryker: LFIT Anatomic CoCr V40 Femoral Heads

May 2018

Joint prosthesis, hip

MHRA reference: 2018/005/025/291/022

Zimmer Biomet: Guide Wire

21 June 2018

Surgical instruments, minimal access

Model: Guide Wire

MHRA reference: 2018/006/021/701/023

Published 2 July 2018