Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system — Class II medical device recall Z-0022-2015
Terminated recall by Philips Medical Systems, Inc., reported 2014-10-15, distributed in FL. Philips had discovered through a field service testing where a device failed to comply with a Federal standard
| Recall number | Z-0022-2015 |
|---|---|
| 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 | 2014-08-08 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2014-12-03 |
| Distributed | FL |
| Serial numbers | 16741023 |
Product
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Reason for recall
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
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-0022-2015. 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.