FDA Device recall Z-1045-2015
Philips Multi Diagnost Eleva with FlatDetector
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of Philips Multi Diagnost Eleva with FlatDetector by Philips Medical Systems, citing 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 highe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1045-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-14 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips Multi Diagnost Eleva with FlatDetector
Reason
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.
Identifiers
| code_info | Product Code: 708037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1045-2015%22
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