Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Recalled by Hitachi America, Ltd., Particle Therapy Division Due to During positioning within the system's 3D to 3D...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi America, Ltd., Particle Therapy Division directly.
Affected Products
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
Quantity: 1
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hitachi America, Ltd., Particle Therapy Division
Hitachi America, Ltd., Particle Therapy Division has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report