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Hitachi America, Ltd., Particle Therapy Division recalls Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: Th
Recalled September 18, 2024 · FDA recall Z-3126-2024 · Hitachi America, Ltd., Particle Therapy Division
Hazard
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. · FDA Class II
Units
1
Sold at
U.S. Nationwide distribution in the states of TN, TX, and WA.
Description
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.
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
Manufacturer(s)
Hitachi America, Ltd., Particle Therapy Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →