The Recall Desk
HighFDA (Devices)·Z-3126-2024·Announced 2024-09-18

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.

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: 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 wit
Manufacturer
Hitachi America, Ltd., Particle Therapy Division
Category
Medical Device — Radiation Therapy
Hazard
  • display-error
  • software-error
  • imaging-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: (01)04560333350006(21)CRUS01(11)190920

Distribution

Distributed nationwide across the United States.

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