FDA Device recall Z-2118-2016
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray…
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray… by Philips Medical Systems Cleveland, citing philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2118-2016 |
| 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 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 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 Core128 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 Core128:System Code #728323, Serial numbers: 320001, 320016, 320076, 320077, 320080, 320085, 320086, 320087,…Ingenuity Core128:System Code #728323, Serial numbers: 320001, 320016, 320076, 320077, 320080, 320085, 320086, 320087, 320088, 320089, 320091, 320113, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336014 |
|---|
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-2118-2016%22
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