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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00530-1
Product Name/Description	Azurion and Allura Xper series Product Codes: 722012, 722023, 722026, 722028, 722035, 722079 Serial Numbers: 1229, 1369, 863, 121, 122, 619, 1955, 2924, 460, 505, 589, 748, 1, 10, 11, 6, 84, 1104, 233, 234, 302, 31, 316, 337, 341, 346, 369, 557, 66, 703529, 740, 75, 752 ARTG 225815 (Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/06/2023
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Potential for loss of mechanical movements and FlexMove Carriage with C-Arc Assembly to fall. This issue is due to the forces applied during the movement of the C-Arc of the Azurion and Allura systems, the bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the FlexMove Carriage. As of May 2023, Philips has received fourteen (14) complaints related to eleven (11) systems reporting loose and/or broken bolts. In three (3) cases cracks were also identified. In none of these cases the C-Arc Assembly fell or dropped. No harm to patients or bystanders was reported.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers should keep the Urgent product defect correction notice with the documentation of the system until Philips corrects their system. Philips will inspect all affected systems to: - Check if there are cracks in the FlexMove Carriage - Check if the FlexMove Carriage’s bolts are secured properly - Replace any loose bolts and broken bolts. In case of cracks in the FlexMove Carriage or abnormal noise during transversal movements of the C-Arc, customers should contact Philips so that inspection of their system can be prioritised.
Contact Information	1800 251 400 - Philips Service Delivery Team