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.
Other recalls by Philips Medical Systems
- Spectral CT and Spectral CT 7500 RT
FDA Device · Class II · 2026-10-14 · Philips Medical Systems - IQon Spectral CT IQon Spectral CT Upgrades
FDA Device · Class II · 2026-08-05 · Philips Medical Systems - Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
FDA Device · Class II · 2026-08-05 · Philips Medical Systems - Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 12…
FDA Device · Class II · 2026-08-05 · Philips Medical Systems - Philips Spectral CT on Rails
FDA Device · Class II · 2026-04-22 · Philips Medical Systems
All Philips Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1045-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.