Field Safety Notice: 20 to 25 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 20 to 25 May 2019

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

Abbott: Alinity c

16 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/020/701/014

Abbott: Architect

16 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/020/701/013

Abbott: MitraClip XTR Delivery System

1 May 2019

Implants, non-active, cardiovascular heart valves CDS0602-XTR

MHRA reference: 2019/004/029/291/006

Biomet Zimmer: Oxford Knee Anatomic Meniscal Bearing

21 May 2019

Joint prosthesis, knee

MHRA reference: 2019/005/021/487/006

EDAP TMS: Sonolith i-sys

05 December 2018

Lithotripsy, external and internal

MHRA reference: 2019/005/016/291/004

EKF-diagnostic: Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit

21 May 2019

IVDs, extra laboratory testing

MHRA reference: 2019/005/021/701/018

Edwards Lifesciences: Intro-Flex® Percutaneous Sheath Introducers

FCA 132

Vascular cannula and catheters I355BF9

MHRA reference: 2019/005/021/701/010

Medtronic: O-arm 1000 Imaging System

May 2019

X Ray, fluoroscopy systems

MHRA reference: 2019/005/015/291/002

Medtronic: My Therapy App for Sacral Neuromodulation Therapy

May 2019

Implants, active, stimulators, neuro A510

MHRA reference: 2019/005/016/487/007

Neuromedex GmbH: Brand

14 May 2019

SECURODRAIN / NeuroVac flat silicone drainage 01.3404, 01.3454, 21-0411 and 23-0411

MHRA reference: 2019/005/015/291/001

Pennine Healthcare: Pennine Intro-Uri-Cath

22 May 2019

Urinary catheters and accessories

MHRA reference: 2019/005/020/291/003

Shimadzu Corporation: FDR Go DR-ID 800

14 December 2018

X Ray, mobiles

MHRA reference: [2019/005/020/701/018]https://mhra-gov.filecamp.com/s/IX25zeuPbNETqQLo/d)

Stanmore: Femoral Heads

19 February 2019

Joint prosthesis, hip

msfmh/cc28-3.5

MHRA reference: 2019/002/019/487/019

Thermo Fisher: Tests based on NAD(H)/NADP(H) reaction, see cat.no

16 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/023/487/009

Von Ardenne Institut für Angewandte Medizinische Forschung: IRATHERM1000

09 April 2019

Heating, patient, electrical pads & blankets

MHRA reference: 2019/005/017/291/001

Xhale Assurance: Nasal Alar SpO2 Sensor

May 2019

Monitors, patient

MHRA reference: 2019/005/011/701/004

Updates to this page

Published 29 May 2019