FDA Device recall Z-2190-2019
iCT SP Model # 728311, 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 iCT SP Model # 728311, 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-2190-2019 |
| 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
iCT SP Model # 728311, 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 83001- 83006, 100109, 200003 through 200069, 200071, 200073 through 200138, , 200200 through 200217, 200000261, 200206, 314329, 713513 |
|---|
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-2190-2019%22
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