The Recall Desk
HighFDA (Devices)·Z-3125-2024·Announced 2024-09-18

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.

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 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 wit
Manufacturer
Hitachi America, Ltd., Particle Therapy Division
Category
Medical Device — Radiation Therapy / Proton Beam System
Hazard
  • image-display-malfunction
  • treatment-positioning-error

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

Distributed nationwide across the United States.

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