Easy Diagnost Eleva Universal Fluoroscopic applications — Class II medical device recall Z-0431-2014
Terminated recall by Philips Medical Systems, Inc., reported 2013-12-11, distributed nationwide. The delivered application software was an outdated version to the model of equipment.
| Recall number | Z-0431-2014 |
|---|---|
| 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 | 2013-10-30 |
| Classified | 2013-12-02 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2017-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 19 devices |
| Reason classes | software |
Product
Easy Diagnost Eleva Universal Fluoroscopic applications
Reason for recall
The delivered application software was an outdated version to the model of equipment.
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-0431-2014. 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.