Device product
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
Z-3127-2024
Product summary
- Event
- Event 94928
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-3127-2024
Official wording
Reason: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
Code information: Lot Code: This products has no UDI. Serial No.: 2015B01
Distribution pattern: U.S. Nationwide distribution in the states of TN, TX, and WA.
Derived failure modes
-
Unknown
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.