Philips Medical Systems Allura Xper FD20C Radiological Imaging with… — Class II medical device recall Z-0181-2015
Terminated recall by Philips Medical Systems, Inc., reported 2014-11-19, distributed in IL, TN. Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detect
| Recall number | Z-0181-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-07-08 |
| Classified | 2014-11-07 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2017-01-18 |
| Distributed | IL, TN |
| Countries outside the US | AR, AU, BE, CH, DE, DK, EG, FR, GB, HK, IT, JP, KR, NL, NO, SA, VN |
| Quantity | 22 systems |
Product
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Reason for recall
Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
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-0181-2015. 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.