Field safety notices - 1 to 5 June 2015

List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 June 2015.

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.

Aesculap: S4C occiput torque wrench f/set screw

1 June 2015

Surgical instruments, implant

Model: FW103R

MHRA reference: 2015/006/001/701/022

Alcon Laboratories: Alcon Accurus standalone vitreous probe packs

3 June 2015

Phacoemulsification / vitrectomy systems

MHRA reference: 2015/006/004/291/013

Astraia software: astraia FMF - first trimester risk screening for trisomy 21

22 May 2015

IVD, genetic testing

Model: astraia software for women’s health

MHRA reference: 2015/005/028/071/010

Bio-Rad Medical Diagnostics: Biotestcell-I11

1 June 2015

IVDs, blood transfusion

MHRA reference: 2015/006/002/291/018

Brahms, part of Thermofisher Scientific: BRAHMS PCT direct

1 June 2015

IVDs, clinical chemistry

MHRA reference: 2015/006/002/291/013

Edwards Life Sciences: EV1000 NI heart reference sensor

June 2015

Monitors, patient

MHRA reference: 2015/006/003/071/002

Edwards Life Sciences

May 2015

Vascular cannula and catheters

Model: IntraClude intra-aortic occlusion device, ICF100

MHRA reference: 2015/005/019/291/008

Fresenius Medical Care. CRIT-LINE® blood chamber

FA-2015-6; MDSS ref.: MDD15.065

Dialysis, blood lines

MHRA reference: 2015/005/028/071/006

GE Healthcare Integrated IT Solutions: Centricity PACS-IW with universal viewer

Ref# 85386B

Picture archiving and communication system (PACS)

Model: versions 5.0 through 5.0 Sp5.1

MHRA reference: 2015/006/002/291/017

Integra NeuroSciences: Camino® intracranial pressure monitoring catheter

29 May 2015

Monitors, patient

Model: 110-4L

MHRA reference: 2015/006/001/701/023

Intuitive Surgical: 420343-01 420343-02

2 June 2015

Surgical instruments, articulated holding

Model: EndoWrist® 5mm thoracic grasper

MHRA reference: 2015/006/003/701/001

Lohmann & Rauscher

28 May 2015

Surgical drapes, gowns, masks

MHRA reference: 2015/005/029/051/007

One Lambda: Lambda Cell Trays™

27 May 2015

IVDs, immunology

Model: LCT1W30, LCT1W60

MHRA reference: 2015/006/002/701/003

Optimedica Corporation: Catalys precision laser system

May 2015

Therapy, lasers

Model: CATALYS-I

MHRA reference: 2015/005/018/291/001

Philips: Expression MRI patient monitoring system

4 May 2015

Monitors, patient

Model: 865214

MHRA reference: 2015/006/001/291/011

Roche Diagnostics: S3 fluid pack A

21 May 2015

IVDs, extra laboratory testing

MHRA reference: 2015/005/028/071/007

Siemens Healthcare Diagnostics: RAPIDLab 1260 and RAPIDLab 1265

May 2015

IVDs, extra laboratory testing

MHRA reference: 2015/005/006/601/002

Sorin Group: Heating unit, pad, water, system

3 June 2015

Blood/fluid warming systems

Model: 16-02-50, 16-02-80, 16-02-81, 6-02-82, 16-02-85, 16-02-95

MHRA reference: 2015/006/004/291/009

Stryker Instruments: TARGET 360 SOFT 3.5MM X 10CM, TARGET 360 NANO 1.5MM X 4CM, TARGET 360 NANO 1.0MM X 3C, TARGET 360 SOFT 6.0MM X 15CM, TARGET 360 ULTRA 3.5MM X 8CM.

29 May 2015

Implants, non-active, embolisation products

Model: M0035473510, M0035421030, M0035421540, M0035423580, M0035476150

MHRA reference: 2015/006/001/291/001

Teleflex: Hudson RCI SHERIDAN SHER-I-BRONCH endobronchial tube

29 May 2015

Airway devices

MHRA reference: 2015/006/002/291/004

Thermo Fisher Scientific: TCAutomation™ /enGen™ Laboratory Automation System

May 2015

IVDs, clinical chemistry

MHRA reference: 2015/005/011/601/001

Varian: VariSource™ iX Afterloader (console software)

18 May 2015

Radiotherapy, afterloading

Model: H60

MHRA reference: 2015/005/029/701/001

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