Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT Recalled by Hitachi America, Ltd., Power Systems Division Due to At a PROBEAT III site installed in Japan,...
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 WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Quantity: 3
Why Was This Recalled?
At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.
Where Was This Sold?
Distribution in US (Texas) and Japan
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