FDA Device recall Z-2277-2018
Ingenuity Core128/Elite China 728324
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Ingenuity Core128/Elite China 728324 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-2277-2018 |
| 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/Elite China 728324
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)00884838059863(21)336856, Serial Number: 336856; UDI: (01)00884838059863(21)336851, Serial Number: 336851;…UDI: (01)00884838059863(21)336856, Serial Number: 336856; UDI: (01)00884838059863(21)336851, Serial Number: 336851; UDI: (01)00884838059863(21)336849, Serial Number: 336849; UDI: (01)00884838059863(21)336852, Serial Number: 336852; UDI: (01)00884838059863(21)336853, Serial Number: 336853; UDI: (01)00884838059863(21)336855, Serial Number: 336855; UDI: (01)00884838059863(21)336854, Serial Number: 336854; UDI: (01)00884838059863(21)336850, Serial Number: 336850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2018%22
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