FDA Device recall Z-2187-2019
Ingenuity Core128 Model # 728323, computed tomography x-ray system
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of Ingenuity Core128 Model # 728323, computed tomography x-ray system by Philips Medical Systems Cleveland, citing in certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2187-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-24 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Reason
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Identifiers
| code_info | System Serial Number 6123, 30016, 30023, 300068, 30153, 32000 through 320513, 52023, 52028 336001 through 336038, 336…System Serial Number 6123, 30016, 30023, 300068, 30153, 32000 through 320513, 52023, 52028 336001 through 336038, 336040 through 336051, 336053, 336055 through 336061, 336063 through 336379, 336382 through 336454, 336701 through 336811, 345218, 760014, 21003-05, 320309, 32053, 32060, 336039-1 336143, 336147, 336331, 7175_06 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Philips Medical Systems Cleveland recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2187-2019%22
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