Ingenuity Core128/Elite China 728324 — Class II medical device recall Z-2277-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-07-04, distributed in HI, KS, MO. A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil lea
| Recall number | Z-2277-2018 |
|---|---|
| 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 | 2018-03-28 |
| Classified | 2018-06-22 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-04-21 |
| Distributed | HI, KS, MO |
| Countries outside the US | AT, BR, CN, DZ, ID, JP, KE, KR, MX, PL, TR |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00884838059863 |
| Serial numbers | 336849, 336850, 336851, 336852, 336853, 336854, 336855, 336856 |
Product
Ingenuity Core128/Elite China 728324
Reason for recall
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
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-2277-2018. 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.