FDA Device recall Z-0597-2017
Ingenuity Core Computed Tomography X-ray system, Model 728321
- FDA Device
- Class III
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class III recall of Ingenuity Core Computed Tomography X-ray system, Model 728321 by Philips Medical Systems Cleveland, citing the product label does not include the correct current rating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0597-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-13 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, OR, PA, SC, TN, TX, UT, VA |
Product
Ingenuity Core Computed Tomography X-ray system, Model 728321
Reason
The product label does not include the correct current rating.
Identifiers
| code_info | 310160, 310234 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.