FDA Device recall Z-0175-2016
Ingenuity Core Computed Tomography X-ray systems
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of Ingenuity Core Computed Tomography X-ray systems by Philips Medical Systems Cleveland, citing the firm discovered Ring/Dot artifact due to X-ray measurement error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0175-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-14 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Reason
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Identifiers
| code_info | Model No. 728321; S/N: 52000, 52001, 52002, 52003, 52004, 52006, 52009, 52011, 52012, 52015, 52016, 52017, 52020, 52022…Model No. 728321; S/N: 52000, 52001, 52002, 52003, 52004, 52006, 52009, 52011, 52012, 52015, 52016, 52017, 52020, 52022, 52025, 52027, 52029, 310116, 310150, 310152, 310153, 310154, 310155, 310156, 310158, 310161, 310162, 310163, 310164, 310166, 310171, 333013, 333026, 333027, 333028, 333032, 333035, 333036, 333037, 333038, 333039 &333042. |
|---|
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-0175-2016%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.