Hitachi America, Ltd., Particle Therapy Division recalls Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The P…

Recall date

May 27, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3125-2024

FDA classification

Class II

Brand / firm

Hitachi America, Ltd., Particle Therapy Division

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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