Ingenuity Core — Class II medical device recall Z-2657-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-08-31, distributed nationwide. After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the p
| Recall number | Z-2657-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-07-20 |
| Classified | 2016-08-25 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 30 |
| Reason classes | software |
| Model numbers | 728321 |
Product
Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason for recall
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2657-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.