Z-2275-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2018
- Initiation Date
- March 28, 2018
- Termination Date
- April 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 total
Product Description
Ingenuity Core128 728323
Reason for Recall
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.
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.
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