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