FDA recall Z-3126-2024

Hitachi America, Ltd., Particle Therapy Division · Class II · device

Product

Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR 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

U.S. Nationwide distribution in the states of TN, TX, and WA.

Key facts

Status
Ongoing
Initiation date
2024-05-27
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clara, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3126-2024