Ingenuity Core 128-Computed Tomography X-ray system Product Usage:… — Class II medical device recall Z-2118-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-07-06, distributed nationwide. Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software ver
| Recall number | Z-2118-2016 |
|---|---|
| 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 | 2016-04-01 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 19 |
| Reason classes | software |
| Serial numbers | 320001, 320016, 320076, 320077, 320080, 320085, 320086, 320087, 320088, 320089, 320091, 320113, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336014 |
Product
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system 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
Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
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-2118-2016. 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.