Field safety notices - 24 to 28 August 2015

List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 August 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

Amanta Healthcare: Emergency Sterile Eye Wash (Sodium chloride 0.9% w/v Ph.Eur

20 August 2015

Contact Lenses, Care Products

MHRA reference: 2015/008/024/291/001

Apatech: Actifuse ABX, Actifuse MIS System, Inductigraft

August 2015

Implant Materials, Bone Substitutes

MHRA reference: 2015/008/024/291/039

bioMerieux: chromID™ S.aureus agar Ref.43371chromID™ MRSA agar / chromID™ S. aureus agar (MRSA/SAID) – Ref. 43466chromID™ MRSA agar / chromID™ S. aureus agar (MRSAV1/SAID) (for US only) – Ref. 414524

19 August 2015

IVDs, Bacteriology

MHRA reference : 2015/008/021/291/001

Charder electronic: Charder Weigh Scale

18 August 2015

Therapy, Scales

Model: MHS 2500

MHRA reference: 2015/005/008/292/008

Edwards Life Sciences: Edwards Commander Delivery System

20 August 2015

Implants, Non Active, Cardiovascular Heart Valves

Model: 9610TF23, 9610TF26, 9610TF29

MHRA reference: 2015/002/010/081/024

GE Medical Systems: Lightspeed 16 CT, PET Discovery ST 16, LightSpeed Ultra 16, PET Discovery LS, and LightSpeed Pro 16

FMI25463

Computed tomography

MHRA reference: 2015/008/021/291/012

One Lambda: LABType HD DRB1 typing test

26 August 2015

IVDs, immunology

Model: RSSOH2B1

MHRA reference: 2015/008/028/291/012

Philips Medical Systems: Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128

18 July 2014

Computed tomography

Model: 728231: Brilliance 64, 728326: Ingenuity CT, 728321: Ingenuity Core 728323: Ingenuity Core128

MHRA reference: 2015/008/027/081/008

Physio-Control: LIFEPAK 1000 defibrillator

May 2015

Defibrillators, non implantable

Model: 320371500xxx

MHRA reference: 2015/008/026/291/002

Siemens AG Healthcare: syngo RT Therapist / PRIMUS, ONCOR, ARTISTE

TH001/15/S und TH002/15/S

Radiotherapy

Model: 008162815 // 04504200, 05857912, 07360717, 09139789

MHRA reference: 2015/008/024/601/001

Siemens AG Healthcare: syngo RT oncologist

TH003/15/S

Radiotherapy

Model: 010568604

MHRA reference: 2015/008/024/601/003

Siemens Healthcare Diagnostics: ADVIA Centaur Systems HBsAg II

August 2015

IVDs, clinical chemistry

Model: 10492138

MHRA reference: 2015/008/027/601/008

Siemens Medical Solutions: ACUSON SC2000

UI US024/15/S

Ultrasound, imaging

Model: 10433816

MHRA reference: 2015/008/025/601/001

Siemens Healthcare Diagnostics: syngo lab data manager

ISW-15-05.A.OUS - August 2015

IVDs, Clinical Chemistry

Model: 10638933, 10624077, 10804573

MHRA reference: 2015/008/027/601/001

Siemens Healthcare Diagnostics: measurement cartridge, Rapidpoint 500 (Mcart LAC)

CC 15-23.A.OUS - August 2015

IVDs, extra laboratory testing

MHRA reference: 2015/008/027/601/010

Smiths Medical: Medfusion™ Stopcocks, 4-way, Medfusion™ Stopcocks, 3-way, Medfusion™ Stopcocks, 1-way

03 August 2015

Infusion & transfusion, connectors

MHRA reference: 2015/008/006/291/002

Stryker Instruments-Kalamazoo: Neptune 2 Docking Station – Actuator Assembly

25 August 2015

Surgical devices, non-powered

MHRA reference: 2015/008/019/291/002

Synergy Health: Zethon

29 July 2015

Surgical, diathermy

Model: VC-094-D, VC-096-D, VC-099-D

MHRA reference: 2015/007/030/601/004

Teleflex: Flexi‐Slip Endotracheal Tube Stylet with soft distal tip Flexislip Stylet, sterile pack

24 August 2015

Airway Devices

MHRA reference: 2015/008/024/291/042

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