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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 040 05 12 000
Date submitted:	5/14/2012

Manufacturer:	Philips Healthcare
Device Type:	Computed Tomography, Brilliance iCT and iCT SP
Description:	CT, scanner, cooling unit
Medical Device Identifier:	Brilliance iCT and iCT SP
Reason of Field Safety Corrective Action:	Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds.
Remedy Action:	Philips Healthcare is notifying all Brilliance iCT and iCT SP customers of this issue via this Field Safety Notice, and will inspect the cooling units on all iCT and iCT SP systems, including yours, for this issue. If the welds on a cooling unit do not pass the inspection, Philips will replace the cooling unit free of charge.
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:	NCMDR
Source Ref. Number:	F49FA509A62E7
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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