Device product
Ingenuity Core128 728323
Z-2275-2018
Product summary
- Event
- Event 80176
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 total
- Official record key
device-enforcement:Z-2275-2018
Official wording
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.
Code information: 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
Distribution pattern: The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
Derived failure modes
-
Manufacturing or process control
production defect