Field safety notices - 13 to 17 April 2015

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 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

Biomet UK: Exceed ABT spring loaded impactor

24 March 2015

Device description: surgical instruments, implant

MHRA reference: 2015/004/014/701/004

CareFusion UK 305: Alaris® Pump Model 8015

March 2015

Device description: infusion systems

MHRA reference: 2015/003/031/071/005

CryoConcepts

07 April 2015

Device description: surgical, cryogenic

Model: CryOmega, 100-1001

MHRA reference: 2015/004/013/291/008

Depuy Synthes: Colibri II oscillating saw attachment

8 April 2015

Device description: surgical power tools

MHRA reference: 2015/004/013/291/007

Ennogen Healthcare: Uniscope laryngoscope handle

29 January 2015

Device description: endoscopes, rigid

MHRA reference: 2014/012/011/081/007

Etac Supply: MRS traverse switch

27 March 2015

Device description: hoists and slings

MHRA reference: 2015/004/013/291/001

Gambro Dialysatoren: Revaclear 400

10 April 2015

Device description: dialysis, haemodialysis

MHRA reference: 2015/004/013/291/009

GAMMA - Diaxonhit: Tetanos Quick Stick - TQS

8 April 2015

Device description: IVDs, immunology

MHRA reference: 2015/004/010/291/002

GE Medical Systems Information Technologies: Treadmill T2100 and Treadmill T2000

FMI30073

Device description: diagnostic measurement and monitoring

Model: T2100 & T2000 Treadmills with power cord part numbers

MHRA reference: 2015/004/014/291/008

GE Medical Systems Information Technologies: T2100 treadmill

Ref number: 30074

Device description: diagnostic measurement and monitoring

MHRA reference: 2015/004/014/291/009

Geistlich Pharma: Orthoss collagen

27 March 2015

Device description: implant materials, bone substitutes

MHRA reference: 2015/003/024/701/006

Hansen Medical: Magellan robotic system

10 April 2015

Device description: therapy tissue ablation

Model: 11139

MHRA reference: 2015/004/013/291/010

Idoman Teoranta: Thermablate EAS

31 March 2015

Device description: therapy tissue ablation

Model: Thermablate EAS - 22101

MHRA reference: 2015/004/016/291/006

Maquet: Cardiosave Hybrid intra-aortic balloon pump

30 January 2015

Device description: cardiac assist pumps

Model: 0998-00-0800-XX & 0998-UC-0800-XX

MHRA reference: 2015/002/004/081/032

Maquet Critical Care AB: FLOW-i

31 March 2015

Device description: anaesthetic machines & monitors

Model: 6677200 FLOW-i C20,6677300 FLOW-i C30,6677400 FLOW-i C40

MHRA reference: 2015/004/007/071/001

Medtronic: SynchroMed® II implantable drug pumps

14 April 2015

Device description: implants, active, infusion pumps

Model: 8637-20, 8637-40

MHRA reference: 2015/004/014/291/013

Ortho-Clinical Diagnostics: ORTHO VISION™ analyser

April 2015 (CL2015-076)

Device description: IVDs, blood transfusion

MHRA reference: 2015/004/010/601/004

Ortho-Clinical Diagnostics: VITROS

April 2015

Device description: instrumentation

Model: FS 5,1; 4600 and 5600

MHRA reference: 2015/004/010/601/003

Roche Diagnostics: cobas b123 <3> POC system, cobas b123 <4> POC system

10 April 2015

Device description: IVDs, extra laboratory testing

Model: cobas b123 <3> POC system, cobas b123 <4> POC system; 05122279001; 05122287001

MHRA reference: 2015/004/015/701/010

Siemens Healthcare Diagnostic: IMMULITE/IMMULITE 1000 TBG

April 2015

Device description: IVDs, clinical chemistry

Model: LKTB1/10381643

MHRA reference: 2015/004/008/601/005

Specialty Appliances: Universal nut on Herbst appliances

13 April 2015

Device description: dental appliances / instruments

MHRA reference: 2015/004/015/701/012

Teleflex Medical: PPH basic insertion pack

15 April 2015

Device description: surgical devices, non-powered

MHRA reference: 2015/004/015/291/006

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