Field Safety Notice - 8 to 12 January 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 January 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

BioMerieux SA: MINI VIDAS ANALYSER VIDAS ANALYSER Quality Control VIDAS

09 January 2018

IVDs, viral microbiology

MHRA reference: 2018/001/010/000/001

Boston Scientific Corporation(Stryker): Guider Softip TM XF Guide Catheter

03 January 2018

Vascular cannula and catheters

MHRA reference: 2017/012/022/291/022

GE Medical Systems: 9100c/Aelite

January 2018

Anaesthetic machines & monitors

MHRA reference: 2018/001/010/000/012

Gebrueder Martin: LASER PROT.GOGGLES UNIV Nd:YAG,CO2,DIODE

29 December 2017

Therapy, lasers

Model: LASER PROT.GOGGLES UNIV Nd:YAG,CO2,DIODE 79-100-56-04

MHRA reference: 2018/001/011/291/004

ICU Medical: Plum 360 (30010) Infusion Pump

21 June 2017

Infusion systems

Model: Plum 360 (30010)

MHRA reference: 2017/006/013/291/012

Implant Direct: SwishTapered™ Implant / SwishPlus™ Implant

January 2018

Implants, dental

Model: 934106, 934806, 934812, 934814, 924116, 924810W, 924814, 924108, 924112, 924806, 924112, 924812W, 934106, 934112, 935712

MHRA reference: 2018/001/006/601/001

Integra LifeSciences (Ascension Orthopedics): TITAN (TSS) Humera Stem Trials

28 December 2017

Joint prosthesis, shoulder

MHRA reference: 2017/012/021/291/036

Medos International Sarl

January 2018

Surgical instruments, non-articulated cutting

Model: 288204 LATARJET EXPERIENCE Sharp Curve Ostetome

MHRA reference: 2018/001/009/291/023

Menicon: MeniCare Soft 70ML

04 January 2018

Contact Lenses, Care Products

MHRA reference: 2018/001/009/291/007

Philips Healthcare: Intellivue iX Information Center Software

3 January 2018

Monitors, patient

Model: 866023, 866117, 866389, 867141

MHRA reference: 2018/001/011/291/008

Philips Medical Systems (Cleveland): Precedence

BrightView X BrightView SPECT BrightView XCT

15 December 2017

Nuclear Medicine, Gamma Camera Systems & Accessories

Model: 882350 Precedence 16 882351 Precedence 6 Slice 882478 BrightView X 882480 BrightView SPECT 882482 BrightView XCT

MHRA reference: 2018/001/009/000/014

Siemens: syngo Workflow MLR

18 December 2017

Picture archiving and communication system (PACS)

MHRA reference: 2018/001/005/601/011

Siemens Healthcare Diagnostics: Advia Centaur DHEAS, Advia Centaur CSA, Advia Centaur Folate, Advia Centaur HBc IGM

January 2018

IVDs, clinical chemistry

Model: DHEAS, CSA, Folate, HBc IGM assays run on Advia Centaur

MHRA reference: 2018/001/005/601/007

Source BioScience: FIXOL (Fixative for Kleihauer)

20 December 2017

IVDs, blood transfusion

Model: 05-051

MHRA reference: 2017/012/022/601/008

Published 15 January 2018