FDA Device recall Z-2371-2016
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-… by Philips Medical Systems Cleveland, citing software defect causing intermittently slow response of Host.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2371-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-24 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV, WY |
Product
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
Software defect causing intermittently slow response of Host.
Identifiers
| code_info | Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310…Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135. |
|---|
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-2371-2016%22
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