FDA Device recall Z-0810-2016
Actuator for angiographic x-ray monitor ceiling suspension system
- FDA Device
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of Actuator for angiographic x-ray monitor ceiling suspension system by Philips Electronics North America, citing the actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0810-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-06 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
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
Reason
The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Identifiers
| code_info | Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2016%22
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