FDAFDA · Food and drugs·Recall number Z-3125-2024
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 with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
Published September 18, 2024 · Recall initiated: May 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hitachi America, Ltd., Particle Therapy Division
- Distributor
- U.S. Nationwide distribution in the states of TN, TX, and WA.
- Lot
- Lot Code: UDI:(01)04560333350204(11)240112(21)PTFR-01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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