FDA Device recall Z-2275-2018
Ingenuity Core128 728323
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Ingenuity Core128 728323 by Philips Medical Systems Cleveland, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2275-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-28 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | HI, KS, MO |
Product
Ingenuity Core128 728323
Reason
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.
Identifiers
| code_info | UDI: (01)00884838059504(21)320403, Serial Number: 320403; UDI: (01)00884838059504(21)320405, Serial Number: 320405;…UDI: (01)00884838059504(21)320403, Serial Number: 320403; UDI: (01)00884838059504(21)320405, Serial Number: 320405; UDI: (01)00884838059504(21)320406, Serial Number: 320406; UDI: (01)00884838059504(21)336321, Serial Number: 336321; UDI: (01)00884838059504(21)320411, Serial Number: 320411; UDI: (01)00884838059504(21)336323, Serial Number: 336323; UDI: (01)00884838059504(21)320425, Serial Number: 320425; Serial Number: 320122 |
|---|
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-2275-2018%22
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