Azurion lnterventional Fluoroscopic X-ray System — Class II medical device recall Z-1997-2019
Terminated recall by Philips Medical Systems Nederlands, reported 2019-08-07, distributed nationwide. Philips has discovered through customer complaints and internal testing an intermittent electronic product def
| Recall number | Z-1997-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Medical Systems Nederlands, Best, N/A, Netherlands |
| Recall initiated | 2018-11-30 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 229 |
| Reason classes | software |
Product
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Reason for recall
Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
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-1997-2019. 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.