Allura Xper FD OR Table — Class II medical device recall Z-0765-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-02-17, distributed in IN, TN. Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic
| Recall number | Z-0765-2016 |
|---|---|
| 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 | 2015-11-03 |
| Classified | 2016-02-05 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-08-19 |
| Distributed | IN, TN |
| Countries outside the US | AU, BE, DE, EG, FR, JP, KR, NL, SA |
| Quantity | 2 subject |
Product
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
Reason for recall
Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced 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-0765-2016. 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.