Recall Z-3127-2024— Hitachi America, Ltd., Particle Therapy Division
Class II · Ongoing
Class II FDA medical device recall by Hitachi America, Ltd., Particle Therapy Division, initiated 2024-05-27. It names one FDA 510(k) clearance: K232032. 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 the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A. Reason: 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..
- Recalling firm
- Hitachi America, Ltd., Particle Therapy Division
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-27
- Firm location
- Santa Clara, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.