Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROBEAT-V Recalled by Hitachi America, Ltd., Power Systems Division Due to There is a potential for a discrepant target...
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., Power Systems Division directly.
Affected Products
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Quantity: 3
Why Was This Recalled?
There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
Where Was This Sold?
This product was distributed to 3 states: AZ, MN, TN
About Hitachi America, Ltd., Power Systems Division
Hitachi America, Ltd., Power Systems Division has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report