Proton therapy system may display insufficient CBCT images during positioning
Hitachi PROBEAT-FR proton therapy systems may display an insufficient number of CBCT images during 3D positioning when the Float Image Selection button is pressed, potentially affecting 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: The PROBEAT-FR is a medical device used for proton radiation therapy with direct patient safety implications. The software issue affects critical CBCT image display during treatment positioning, which is essential for accurate dose delivery. Although no injuries have been reported, the potential for improper patient positioning due to insufficient imaging data presents a meaningful clinical risk.
Plain-English summary
Hitachi America, Ltd. is recalling the PROBEAT-FR proton beam irradiation system due to a software issue in its 3D to 3D matching mode. When performing CBCT (cone beam CT) image transfer and positioning, pressing the Float Image Selection button may cause the system to display an insufficient number of CBCT images.
This issue could impact the accuracy of patient positioning during treatment planning, as proper imaging is critical for accurate proton beam delivery. The recall affects systems distributed in Tennessee, Texas, and Washington.
Clinical staff and facilities using the PROBEAT-FR should contact Hitachi America, Ltd. or the FDA for information regarding correction of this issue. The affected devices are identified by UDI code (01)04560333350204(11)240112(21)PTFR-01.
The recalled product
- Product
- Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR 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: UDI:(01)04560333350204(11)240112(21)PTFR-01
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
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