Proton Beam Therapy System Displays Insufficient CBCT Images on Button Press
Hitachi's PROBEAT-CR proton therapy system may display insufficient CBCT images during image positioning when the Float Image Selection button is pressed. This could affect treatment planning accuracy.
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: FDA Class II medical device affecting critical treatment planning imaging. No illnesses, injuries, or deaths have been reported. The hazard is software-based and theoretical, placing it at the upper bound of risk-of-harm recalls without documented patient harm.
Plain-English summary
Hitachi America, Ltd. is recalling the PROBEAT-CR, a proton beam irradiation system used for therapeutic cancer treatment. The system delivers targeted proton beams to prescribed treatment sites in cancer patients.
A software issue has been identified in the system's 3D to 3D image matching mode. When users press the Float Image Selection button during CBCT image transfer for patient positioning, the system may display an insufficient number of CBCT images. This could compromise the accuracy of treatment planning and patient positioning.
The recall affects PROBEAT-CR systems distributed nationwide in Tennessee, Texas, and Washington. Facilities currently operating this equipment should contact Hitachi America, Ltd., Particle Therapy Division immediately for guidance on remediation or software updates.
The recalled product
- Product
- 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…
- Manufacturer
- Hitachi America, Ltd., Particle Therapy Division
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: (01)04560333350006(21)CRUS01(11)190920
Distribution
Part of a larger recall action
This product is one of 3 recalled by Hitachi America, Ltd., Particle Therapy Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Hitachi America, Ltd., Particle Therapy Division
See all →- 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
Same hazard · display error
See all →- ModerateSpectral Instruments Recalls 35 Ami HTX X-Ray Units
FDA (Devices) · 2026-08-26
- ModerateSpectral Instruments Lago X Medical Device Recalled for Display Glitch
FDA (Devices) · 2026-08-26
- ModerateKico Knee Innovation Recalls ARVIS Surgical Navigation System Due to Sensor Issue
FDA (Devices) · 2026-08-26
- ModerateLinkBio CORE Workstation may display an incorrect planning date
FDA (Devices) · 2026-04-22
- HighHexagon Purus Recalls Tern RC8 Vehicles Due to Brake Display Error
NHTSA · 2026-04-20
Similar recalls
- HighHitachi Proton Beam Therapy System Recalled Due to Software Anomaly
FDA (Devices) · 2026-03-04
- HighHitachi PROBEAT Proton Beam System Recalled for Radiation Delivery Issues
FDA (Devices) · 2015-07-29
- SevereHitachi Proton Beam Therapy System Recall Over Positioning Software Issue
FDA (Devices) · 2026-03-04
- HighHitachi PROBEAT-V Proton Therapy System Software Recall
FDA (Devices) · 2019-07-03
- SevereIon Beam Applications Recalls Two Proteus 235 Proton Therapy Systems
FDA (Devices) · 2017-05-24
- SevereIon Beam Applications Recalls Proteus Proton Beam Therapy Systems
FDA (Devices) · 2018-05-02