Device product
Ingenuity TF PET/CT 882442
Z-2276-2018
Product summary
- Event
- Event 80176
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 total
- Official record key
device-enforcement:Z-2276-2018
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)00884838059443(21)2086, Serial Number: 2086; UDI: (01)00884838059443(21)2099, Serial Number: 2099; UDI: (01)00884838059443(21)2095, Serial Number: 2095; UDI: (01)00884838059443(21)2097, Serial Number: 2097
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