Device product
Philips Ingenuity Core 728321
Z-2274-2018
Product summary
- Event
- Event 80176
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 total
- Official record key
device-enforcement:Z-2274-2018
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)00884838059498(21)333169, Serial Number: 333169; UDI: (01)00884838059498(21)310377, Serial Number: 310377; UDI: (01)00884838059498(21)310375, Serial Number: 310375; UDI: (01)00884838059498(21)333171, Serial Number: 333171; UDI: (01)00884838059498(21)333172, Serial Number: 333172
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