FDA Device recall Z-2117-2016
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system…
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system… by Philips Medical Systems Cleveland, citing philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may app….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2117-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-01 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason
Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Identifiers
| code_info | Ingenuity Core,System Code #728321, Serial numbers: 310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 31…Ingenuity Core,System Code #728321, Serial numbers: 310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 310112, 310115, 310137, 333006, 333008, 333011, 333012, 333013, 333016, 333017, 333023 |
|---|
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-2117-2016%22
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