FDA Device recall Z-2186-2019
Ingenuity CT, Model # 728326, 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 CT, Model # 728326, 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-2186-2019 |
| 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 CT, Model # 728326, 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 10474, 30003, 30005, 30006 through 30009, 30011 through 30015, 30017 through 30050, 30053-30054,…System Serial Number 10474, 30003, 30005, 30006 through 30009, 30011 through 30015, 30017 through 30050, 30053-30054, 30056, 52035, 52049,52051,100367 122276, 300003 Through 300005, 300010 through 300012, 300014, 300016 through 300066, 300068 through 300135, 300136 through 300145, 300147 through 300151, 300153- 300154, 300156 through 300166, 300200 through 300263, 320127, 336053, 339001, 339007, 339008, 339009, 30004-1, 336124 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2186-2019%22
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