Z-3126-2024 Class II Ongoing
FDA device recall Z-3126-2024 was initiated by Hitachi America, Ltd., Particle Therapy Division on May 27, 2024 and is designated Class II. 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 numb… The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- May 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
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 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.
Distribution Pattern
U.S. Nationwide distribution in the states of TN, TX, and WA.
Code Information
Lot Code: (01)04560333350006(21)CRUS01(11)190920