Philips Electronics North America Corporation recalls Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long…

Recall date

July 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0810-2016

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

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, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egyp…

Why it was recalled

The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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; 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table; 722025 Allura Xper FD20 Biplane OR Table; 722026 Allura Xper FD10; 722027 Allura Xper FD10/10; 722028 Allura Xper FD20; 722029 Allura Xper FD20/10; 722035 Allura Xper FD20 OR Table; 722038 Allura Xper FD20/20; 722039 Allura Xper FD20/20 OR Table; 722058 Allura Xper FD20/15; 722123 Field extensions Xper cardio R7.6; 722124 Field extensions Xper vascular R7.6; 722133 Field ext. Xper cardio systems R7.6; 722134 Field ext. Xper vascular systems R7.6; 72249 INTEGRIS BV5000; 722043 INTEGRIS Allura 15-12 (mono); 722121 Field extensions INTEGRIS cardio systems