FDA Device recall Z-2257-2015
Computed Tomography X-ray Systems Ingenuity Core
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of Computed Tomography X-ray Systems Ingenuity Core by Philips Medical Systems Cleveland, citing 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2257-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-05 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
Identifiers
| code_info | Model #728321; Serial #s: 31001, 52007, 52008, 52010, 52012, 52013, 52018, 52020, 52021, 52024, 52026, 52030, 52031, 52…Model #728321; Serial #s: 31001, 52007, 52008, 52010, 52012, 52013, 52018, 52020, 52021, 52024, 52026, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52042, 52043, 52046, 52052, 52053, 52054, 52055, 52057, 52058, 310001, 310002, 310003, 310009, 310017, 310052, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310096, 310111, 310113, 310119, 310121, 310129, 310133, 310134, 310141, 310143, 310144, 310149, 310151, 310157, 310160, 310170, 333002, 333009, 333014, 333015, 333030, 333031, 333037, 333042, 333043, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333056, 333057, 333059, 333060 & 333061. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2257-2015%22
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