Hitachi America, Ltd., Particle Therapy Division: Medical Device Recall in 2024 - (Recall #: Z-3126-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 27, 2024

Date Posted: September 18, 2024

Recall Number: Z-3126-2024

Event ID: 94928

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.

Status: Ongoing

Product Quantity: 1

Code Information:

Lot Code: (01)04560333350006(21)CRUS01(11)190920

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated