Field Safety Notice - 9 to 13 April 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 April 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

Becton Dickinson: BD Vacutainer® Push Button Blood Collection Set

15 March 2018

Storage & collection devices

MHRA reference: 2018/003/016/701/018

Biomet (Zimmer): ZNN and MDN Guide Wires

11 April 2018

Surgical instruments, minimal access

MHRA reference: 2018/004/012/291/003

Change Healthcare: McKesson Cardiology Hemo

12 March 2018

Monitors, patient

MHRA reference: 2018/004/009/291/001

Cook Medical: Rhapsody H-30® Holmium Laser System

02 April 2018

Therapy, lasers

MHRA reference: 2018/004/010/701/014

Covidien (Medtronic): LigaSure™ Exact Dissector, Nano-coated 20.6mm-21cm

March 2018

Surgical, diathermy

MHRA reference: 2018/003/027/478/008

Depuy Synthes GmbH: Synthes Sciatic Nerve Retractor

04 April 2018

Surgical instruments, articulated retracting

Model: 03.100.013 and 03.100.014

MHRA reference: 2018/004/009/291/033

EV3 (Medtronic): 300010, 300011, 300012, 300013 MindFrame CaptureTM LP

April 2018

Vascular cannula and catheters

Model: MindFrame CaptureTM LP

MHRA reference: 2018/003/012/478/003

Genicon: EZee Retrieval

29 March 2018

Surgical instruments, minimal access

Model: EZee Retrieval 550-000-000

MHRA reference: 2018/004/004/291/011

IRIDEX Corporation: TruFocus LIO Premiere

05 April 2018

Therapy, lasers

MHRA reference: 2018/004/005/601/010

LAP GmbH Laser Applikationen: APOLLOblue (24V)

29 March 2018

Therapy, lasers

MHRA reference: 2018/004/006/291/013

Lockdown Medical: LD110 11cm Acromioclavicular (AC) Device

18 October 2016

Osteosynthesis, bone screws

MHRA reference: 2018/004/011/291/010

Medela AG: Medset CM

MIR182-18

Active wound management

Model: 001.0112

MHRA reference: 2018/004/004/601/003

Philips: T5, T10-NT, ACSNT, Intera 0.5T/1.0T, 1.5T, Achieva 1.5T, Multiva 1.5T, Ingenia CX 1.5T and Panorama 1.0T MR systems

March 2018

Magnetic resonance, equipment & accessories

Model: 78104, 78106, 78107, 78108,781072, 78107, 781074, 781076, 781078, 781101, 781102, 781103, 781104, 781105, 781106, 781107, 781108, 781160, 781170, 781171, 781172, 781173, 781174, 781175, 781176, 781178, 781195, 781196, 781250, 781260, 781261, 781262, 781283, 781295, 781296, 781343, 781346, 781382, 781487, 781488, 781492, 781495, 781496, 781497, 781498

MHRA reference: 2018/004/010/291/021

Philips Medical Systems Nederland BV: MultiDiagnost Eleva, UroDiagnost Eleva, MultiDiagnost Eleva with Flat Detector, MultiDiagnost Eleva

28 March 2018

X Ray, Fluoroscopy Systems

Model: - 708032: MultiDiagnost Eleva - 708033: UroDiagnost Eleva - 708034: MultiDiagnost Eleva with Flat Detector - 708035: MultiDiagnost Eleva with Flat Detector - 708036: MultiDiagnost Eleva - 708037: MultiDiagnost Eleva with Flat Detector - 708038: MultiDiagnost Eleva w Flat Detector

MHRA reference: 2018/004/009/291/034

Ranfac

28 March 2018

Surgical instruments, minimal access

Model: Marrow CellutionTMPlease see attached excel sheet

MHRA reference: 2018/003/031/601/002

Scaffdex Ltd: RG000N RegJoint

14 March 2018

Dermal substitues, tissue scaffods

MHRA reference: 2018/003/022/601/006

Siemens: ADVIA Chemistry Urea Nitrogen

April 2018

IVDs, Clinical Chemistry

Model: ADVIA Chemistry Urea Nitrogen

MHRA reference: 2018/004/009/601/002

St. Jude Medical: Nanostim™ Leadless Pacemaker

05 April 2018

Implants, active, pacemakers

Model: S1DLCP

MHRA reference: 2018/004/006/291/012

Thermo Fisher Scientific

26 March 2018

IVDs, bacteriology

Model: CT1412B

MHRA reference: 2018/004/010/601/019

Thoratec Corporation: HeartMate 3™ Left Ventricular Assist System

April 5 2018

Implantable ventricular assist devices

Model: 106524INT HM3 LVAS Kit

MHRA reference: 2018/004/009/291/032

Immucor GTI Diagnostics, Inc: MATCH IT! DNA software

23 March 2018

IVD, genetic testing

MHRA reference: 2018/004/006/291/008

Published 8 May 2018