Phillips Easy Diagnost Eleva DRF — Class II medical device recall Z-0767-2013
Terminated recall by Philips Healthcare Inc., reported 2013-02-13, distributed nationwide. The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication
| Recall number | Z-0767-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2013-01-16 |
| Classified | 2013-02-01 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2017-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 14 units |
| Serial numbers | 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409 |
| Model numbers | 706034 |
Product
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Reason for recall
The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS 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-0767-2013. 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.