FDA Device recall Z-0407-2016
Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
- FDA Device
- Class II
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class II recall of Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system by Philips Electronics North America, citing during scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0407-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-14 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Reason
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Identifiers
| code_info | 728323 |
|---|
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-0407-2016%22
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