FDA Device recall Z-2191-2019
Brilliance 64 Model # 728231, 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 Brilliance 64 Model # 728231, 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-2191-2019 |
| 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
Brilliance 64 Model # 728231, 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 335, 338, 1897, 4001, 4003, 4016, 4021, 9009, 9029-9030, 9033, 9035, 9038, 9040, 9045, 9047, 9048…System Serial Number 335, 338, 1897, 4001, 4003, 4016, 4021, 9009, 9029-9030, 9033, 9035, 9038, 9040, 9045, 9047, 9048, 9052, 9054, 9056, 9058, 9062, 9064-9068, 9070-9077, 9080, 9086, 9087,9089, 9092, 9093, 9098, 9099, 9104- 9108, 9112, 9117 9120, 9121, 9127, 9134, 9138, 9140, 9148, 9159- 9160, , 9171, 9187, 9201, 9208, 9234, 9243, 9501, 9509 through 9608, 9610 through 10288, 10291 through 10327, 10330 through 10339, 10341 through 10808, 10811-10812, 29002, 29005, 29007, 29009, 29012, 29014, 29016-29018, 29020,29022, 29024, 29025-29027, 29032, 29035, 29037-29039, 29044-29045, 29047- 29049 29053- 29054, 29056- 29057, 29062, 29064-29066, 29068, 29081, 29086 29092, 29097, 29102, 29107, 29108, 29111, 29115, 29118, 29124, 29135 29138, 32065, 64045, 64051, 90029- 90031, 90041, 90046, 90047, 90054, 90056, 90058, 90062, 9006390066, 90069, 90072, 90078, 90079, 90081, 90082, 90085, 90086, 90087, 90089,90091, 90094, 90097, 90098, 90107, 90111, 90119, 90123-90124, 90128, 90131, 90135, 90136 |
|---|
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-2191-2019%22
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