Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Allura XPER FD20 BIPLANE; 722015 Allura Xper FD20 OR Table; 722020 Allura Xper FD20 Biplane OR Table;

Recall Insight

This FDA Devices action (record #Z-0810-2016) was formally reported on February 24, 2016, with the manufacturer initiating the action on July 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Electronics North America Corporation is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 3158 devices.

The documented reason for this recall is: The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, Chile, China, Colomb…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.