Hitachi PROBEAT Proton Beam System Recalled for Radiation Delivery Issues
Hitachi America is recalling three PROBEAT proton beam systems due to potential radiation delivery inconsistencies during system reboots.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect could lead to incorrect radiation dosing, but the source text does not report any patient injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Hitachi America, Ltd., Power Systems Division, is recalling three units of the PROBEAT with Discrete Spot Scanning System. These medical devices are designed to produce and deliver proton beams for the treatment of localized tumors and other conditions susceptible to radiation therapy.
The recall was initiated after an operator at a PROBEAT III site in Japan discovered that radiation was delivered inconsistently with the treatment plan and stopped the irradiation. The investigation indicates that the irradiation control system may be potentially affected when rebooting a part of the control system.
The affected units are distributed in the United States (Texas) and Japan. Because each system is designed for a specific facility, no serial numbers or lot codes are required for traceability. Users of these systems should contact Hitachi America for further instructions regarding the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Hitachi America, Ltd., Power Systems Division
- Affected units
- 3
Distribution
Distributed in 1 state:
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