Philips Multi Diagnost Eleva II — Class II medical device recall Z-1044-2015
Terminated recall by Philips Medical Systems, Inc., reported 2015-03-04, distributed nationwide. The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for
| Recall number | Z-1044-2015 |
|---|---|
| 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 | 2013-10-14 |
| Classified | 2015-02-26 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2017-01-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CH, CO, DE, GB, IE, TR |
| Quantity | 238 |
Product
Philips Multi Diagnost Eleva II
Reason for recall
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
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-1044-2015. 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.