Philips Medical System Allura Xper X-Ray Angiographic — Class II medical device recall Z-1120-2015
Terminated recall by Philips Medical Systems, Inc., reported 2015-03-11, distributed nationwide. In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible s
| Recall number | Z-1120-2015 |
|---|---|
| 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 | 2014-06-06 |
| Classified | 2015-03-02 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2021-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, TH, TR, TW, UA, VN, ZA |
| Quantity | 7,439 |
| Reason classes | software |
Product
Philips Medical System Allura Xper X-Ray Angiographic
Reason for recall
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
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-1120-2015. 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.