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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 015 09 12 000
Date submitted: 9/2/2012
Manufacturer:Philips Healthcare
Device Type:Brilliance CT 16 Slice
Description:computed tomography, X-ray
Medical Device Identifier: All Brilliance CT 16 Slice (728246) systems using V2.3.5, ending in Serial Numbers: 6436 - 6505; 6507 - 6515; 6517 - 6520; 6523 - 6526; 6529 - 65336536; 6541; 6543 - 6546; 6549; 6551; 6555.
Reason of Field Safety Corrective Action: The system logout in software version 2.3.6.13001 is longer and may sometimes fail to logout, requiring a forced system restart or "hard" shutdown with the power button. This issue only occurs during the logout process after all clinical work has been completed, and does not affect workflow.
Remedy Action: Philips is implementing software update version 2.3.6.13004 to correct the above mentioned logout issue. This update will be implemented free of charge. Philips will contact you to schedule the software installation at your site. (See attached for USER ACTION)
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:74AF744D94278
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf