Actuator for angiographic x-ray monitor ceiling suspension system — Class II medical device recall Z-0810-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-02-24, distributed nationwide. The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest
| Recall number | Z-0810-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2015-07-06 |
| Classified | 2016-02-16 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-02-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KR, KY, LB, LK, LT, MA, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, RO, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VN, ZA |
| Quantity | 3,158 devices |
| Reason classes | device malfunction |
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 for recall
The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0810-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.