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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00813-1
Product Name/Description Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic x-ray system)

Product Codes: 733001, 722002, 722003, 722005, 722010, 722011, 722014, 722019, 722123 & 722133

ARTG Number: 98560
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/08/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue While the C-arc Base rotation is moved manually and at the same time a motorised Base rotation is initiated followed by a movement stop request the geometry of the System will reset. Consequently the stand movements and table movements then will not be available for about 90 seconds. The table top will be free floating and can manually be moved in both longitudinal and transversal direction
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising users not to initiate a motorised movement of the base rotation when it is moved manually. The system sees this as a conflict and will perform a Geo reset. A software update will be available in Quarter 4 2013.
Contact Information 1800 251 400 - Philips Customer Care Centre