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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 010 01 11 000
Date submitted: 1/5/2011
Manufacturer:Integra Lifesciences
Device Type:Licox Tissue Oxygen Monitors
Description:Patient Monitoring system module, multifunction
Medical Device Identifier:Catalog Number: AC31-EU, Serial nb: 2046
Reason of Field Safety Corrective Action:Potential underestimation of temperature values during monitoring
Remedy Action:discontinue use of any affected products. Contact Integra Local representative to arrange for product return and recalibration
Athorized Representative/Importer/Distributor:Al Nozha Medical Est., Jeddah (02) 6534664
Report Source:NCMDR
Source Ref. Number:0052CAA92E1F3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments