Field Safety Notice - 12 to 16 June 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 June 2017


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

AngioDynamics: Acculis Accu2i pMTA Applicator

June 2017

Therapy tissue ablation

Model: Acculis Accu2i pMTA Applicator

MHRA reference: 2017/006/014/291/001

BELLCO S.r.l.: Formula, Formula Plus, Formula 2000, Formula 2000 Plus, Formula Therapy, Formula Domus

5 January 2017

Dialysis, haemodialysis

MHRA reference: 2016/010/021/291/017

Balt Extrusion: SONIC microcatheter

30 May 2017

Vascular cannula and catheters

Model: All

MHRA reference: 2017/006/012/291/036

Baxter Healthcare: Sharesource Connectivity Platform for use with the Homechoice Claria APD System

14 June 2017

Dialysis, peritoneal

Model: 5CGM01

MHRA reference: 2017/006/014/291/010

Biomet Orthopaedics: Affixus Hip Fracture Nail

08 June 2017

Osteosynthesis, nails intramedullary

MHRA reference: 2017/006/013/291/002

Boston Scientific: Extractor Pro RX-S Retrieval Balloon Catheter

June 2017

Surgical instruments, minimal access

MHRA reference: 2017/006/002/291/005

Carestream: DRX-Revolution Mobile X-Ray System

29 May 2017

X Ray, digital acquisition systems

MHRA reference: 2017/005/031/291/015

Draeger: Infinity Acute Care System (M540)

May 2017

Monitors, patient

Model: MK31501/MK31701/MK31722

MHRA reference: 2017/006/006/291/025

Haemonetics: Cell Saver Elite Processing Kit (225 mL)

08 June 2017

Infusion & transfusion, autologous

MHRA reference: 2017/006/012/291/009

Hain Lifesciences: Analyzer (software) for FluoroType HSV VER 1.0

02 June 2017

IVDs, viral microbiology

MHRA reference: 2017/006/012/291/031

Livanova: Aortic Arch Cannula

June 2017

Vascular cannula and catheters

Model: NA-1116, NA-1137, NA-1206, NA-1207, NA-1208, NA-1337, RA-1126, RA-1127, RA-1136, RA-1137, RA-1138, RA-1206, RA-1207, RA-1208

MHRA reference: 2017/006/013/291/008

Philips Healthcare: HeartStart MRx Defibrillator/Monitor

June 2017

Infusion & transfusion, autologous

Model: M3535A, M3536A

MHRA reference: 2017/006/013/291/005

SHIMADZU Corporation: Fujifilm FDR Visionary Suite


X Ray, digital acquisition systems

MHRA reference: 2017/006/013/701/009

Siemens: ADVIA Centaur Calibrator

June 2017

IVDs, clinical chemistry

MHRA reference: 2017/006/013/601/032

Terumo: RF IK II, RF IK II M coat, Glidesheath Slender

May 2017

Vascular cannula and catheters

Model: See ANNEX 1 of FSN

MHRA reference: 2017/006/002/701/012

Thoratec Corporation: HeartMate 3™ Left Ventricular Assist System

18 May 2017

Implantable ventricular assist devices

MHRA reference: 2017/005/019/291/009

Published 20 June 2017