FDA Device recall Z-2658-2016
Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the b…
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the b… by Philips Medical Systems Cleveland, citing after upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2658-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-20 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Identifiers
| code_info | 728323 -- Ingenuity Core128 320004 320053 320056 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2658-2016%22
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