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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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:
Related recalls
Same manufacturer · Hitachi America, Ltd., Power Systems Division
See all →- HighHitachi PROBEAT-V Proton Therapy System Software Recall
FDA (Devices) · 2019-07-03
Same hazard · radiation exposure
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
Similar recalls
- HighHitachi Proton Beam Therapy System Recalled Due to Software Anomaly
FDA (Devices) · 2026-03-04
- SevereHitachi Proton Beam Therapy System Recall Over Positioning Software Issue
FDA (Devices) · 2026-03-04
- HighProton therapy system may display insufficient CBCT images during positioning
FDA (Devices) · 2024-09-18
- HighProton Therapy System May Display Insufficient Images During Treatment Planning
FDA (Devices) · 2024-09-18
- HighHitachi PROBEAT-V Proton Therapy System Software Recall
FDA (Devices) · 2019-07-03
- HighProton Beam Therapy System Displays Insufficient CBCT Images on Button Press
FDA (Devices) · 2024-09-18