Field Safety Notice - 5 to 9 June 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 June 2017

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: HeartMate 3 LVAS Implant Kit, HeartMate 3 Pump

7 June 2017

Implantable ventricular assist devices

Model: 106524/ 106524INT ,10001696/ 10001696INT

MHRA reference: 2017/006/008/291/007

Alcon: LuxOR / LX3 Microscope Floor Stand

1 June 2017

Surgical equipment, miscellaneous

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

ArjoHuntleigh: Flowtron ACS900

FSN/SUZ/001-2017

Therapy, miscellaneous

Model: 526000-03, 526000-04, 526000-07, 526000-08, 526000-09, 526000-10

MHRA reference: 2017/006/006/701/008

Atrium Medical: Atrium Advanta V12 Balloon Expandable Covered Stent

June 2017

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2017/006/007/291/017

Balt Extrusion: LEO+

5 April 2017

Implants, non active, embolisation products

Model: LEO3.5x25

MHRA reference: 2017/006/005/291/027

Biomet: Comprehensive Nano Humeral Component PPS

6 June 2017

Joint prosthesis, shoulder

MHRA reference: 2017/006/007/291/011

Beckman Coulter: DxH 500

2 June 2017

IVDs, haematology

MHRA reference: 2017/006/002/601/013

Bentley InnoMed: BeGraft Peripheral Plus Stent Graft System

31 May 2017

Implants, non active, peripheral vascular stents

MHRA reference: 2017/005/025/291/024

Draeger: Terminal units and probes

May 2017

Anaesthetic & breathing, medical gas pipelines

MHRA reference: 2017/006/005/291/032

Intersurgical: Manual Resuscitation Systems

5 June 2017

Resuscitators

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

Medela: AXS Universal Aspiration Tubing

30 May 2017

Suction equipment

MHRA reference: 2017/006/005/291/031

Melius Pro B.V.: Simple Up CL (cordless)

June 2017

Trolleys and chairs

Model: SU-1350-CL

MHRA reference: 2017/005/025/291/007

Newdeal: METIS® - Metatarsal trial implant size 1

23 May 2017

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2017/006/005/291/030

Ohmeda Medical: Ohio Infant Warmer Systems

FMI 32047-2

Infant, warmers

Model: New identified models: 3051 Iws, 3400 IWS

MHRA reference: 2017/006/002/291/004

Philips: DuraDiagnost

18 May 2017

X Ray, digital acquisition systems

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

Randox Laboratories: HbA1c

6 June 2017

IVDs, clinical chemistry

Model: HA3830

MHRA reference: 2017/006/006/601/008

ResMed: Astral 100, Astral 100SC, Astral 150

8 June 2017

Lung ventilators

Model: 100, 100SC, 150

MHRA reference: 2017/006/006/291/017

STEPHANIX: D2RS

RC17002

Imaging, patient support

MHRA reference: 2017/005/031/701/009

Toshiba: Diagnostic Ultrasound System

5 June 2017

Ultrasound, imaging

Model: US-X100, TUS-X200, TUS-A300, TUS-A400, TUS-A500 TUS-AI700, TUS-AI800, TUS-AI900 TUW-U001, TUW-U001S

MHRA reference: 2017/006/005/291/028

Unisurge: Unisurge International Limited Supasnip Scissors

25 May 2017

Surgical instruments, articulated cutting

Model: F811004

MHRA reference: 2017/005/024/601/008

Vascular Solutions: Venture RX Catheter, Venture OTW Catheter, and Venture CS Catheter

25 April 2017

Vascular cannula and catheters

Model: 5820, 5821, 5822

MHRA reference: 2017/005/008/291/019

Zimmer Biomet: Various Trauma & Extremity Instruments (Drill bits and Screw taps)

7 June 2017

Orthopaedic surgical instruments - cutting tools

MHRA reference: 2017/006/008/291/002

Zimmer: Trauma Implants

31 May 2017

Osteosynthesis, bone plates

Model: Trauma Implants

MHRA reference: 2017/006/001/701/020

bioMérieux: VITEK 2

25 May 2017

IVDs, bacteriology

MHRA reference: 2017/006/008/291/001

Published 12 June 2017