Z-2273-2018 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
Brilliance Big Bore Radiology 728244
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)00884838059450(21)76064, Serial Number: 76064; UDI: (01)00884838059450(21)76102, Serial Number: 76102; UDI: (01)00884838059450(21)76094, Serial Number: 76094