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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 046 07 14 000
Date submitted:	7/10/2014

Manufacturer:	Philips Healthcare
Device Type:	Allura Xper R8.2.O
Description:	Interventional X-Ray System
Medical Device Identifier:	System: -Allura XPER Systems: FD1OC configuration with Flexmove option, ceiling carriage XIY motion drives. -Allura XPER Systems: FD2OC C-Arc motion drives. -Allura XPER Systems: FD2OC configuration with Flexmove option, C-Arm motion drives and ceiling carriage X/Y motion drives. Product code: 722026, 722028, 722033, 722035
Reason of Field Safety Corrective Action:	As result of a faulty Automatic Motion Controller (AMC), a problem in the Power DESCRIPTION On Self Test (POST) error handling was detected. This can result in a hazardous movement of the C-arc. This can only occur during startup of the system.
Remedy Action:	- The user must be cautious for any unexpected movement of the C-arc and Image Detector when a system start-up (cold restart) is required during a procedure to protect his own safety and the safety of the patient on the table. - A mandatory Field Change Order with reference FC072200253 is being released that requires Philips field service engineers to install Software release R8.2.0.3 which addresses the Positioning Software to respond properly to this error reported by the AMC motion controller during startup of the system The expected date of this FCC will be July, 2014
Athorized Representative/Importer/Distributor:	Philips Healthcare Saudi Arabia Ltd., (011) 4628060
Report Source:	NCMDR
Source Ref. Number:	251FECCDDC2D9
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Philips.pdf

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