Z-3125-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- May 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR 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
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide distribution in the states of TN, TX, and WA.
Code Information
Lot Code: UDI:(01)04560333350204(11)240112(21)PTFR-01