Philips MultiDiagnost Eleva with Flat Detector — Class II medical device recall Z-2156-2012
Terminated recall by Philips Healthcare Inc., reported 2012-08-15, distributed nationwide. When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even whe
| Recall number | Z-2156-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-07-11 |
| Classified | 2012-08-07 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, CZ, DE, DK, ES, FR, GB, IT, LU, LV, NL, SE, TH |
| Quantity | 41 units |
| Serial numbers | 104, 111, 120, 132, 154, 155, 156, 157, 167, 170, 171, 176, 179, 190, 194, 195, 200, 208, 216, 222, 223, 224, 237, 244, 245 and 12 more |
| Model numbers | 708034 |
Product
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Reason for recall
When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
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-2156-2012. 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.