Proton Therapy System May Display Insufficient Images During Treatment Planning
FDA recalls the PROBEAT-V proton beam therapy system due to a software issue where the 3D image positioning mode may display insufficient images, 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: This is an FDA Class II recall of a medical device with a functional defect that could affect treatment accuracy. No injuries or deaths have been reported, placing this in the category of risk-of-harm products where injury has not yet been reported, which corresponds to High severity.
Plain-English summary
The PROBEAT-V is a proton beam irradiation system designed to deliver therapeutic proton beams for clinical cancer treatment. The system is manufactured by Hitachi America, Ltd., Particle Therapy Division.
During the 3D to 3D image matching mode, when operators press the Float Image Selection button to transfer cone beam CT (CBCT) images for treatment positioning, the system may display an insufficient number of images. This defect could affect the accuracy of image-guided treatment planning.
The recalled device with serial number 2015B01 was distributed nationwide to medical facilities in Tennessee, Texas, and Washington. The FDA classified this as a Class II recall.
Facilities currently using this system should contact Hitachi America, Ltd., Particle Therapy Division, for instructions on remediation or corrective action.
The recalled product
- Product
- Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with…
- 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: This products has no UDI. Serial No.: 2015B01
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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