Hitachi America, Ltd., Particle Therapy Division: Device Recall

Recall Details

Recall Number

Z-3125-2024

Classification

Class II

Product Type

Device

Recalling Firm

Hitachi America, Ltd., Particle Therapy Division

Status

Ongoing

Date Initiated

05/27/2024

Location

Santa Clara, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1

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.

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

Distribution Pattern

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

Other Recalls by Hitachi America, Ltd., Particle Therapy Division

• Class II: Risk 05/27/2024
  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: Risk 05/27/2024
  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.

View all recalls by Hitachi America, Ltd., Particle Therapy Division →