Recall Z-3126-2024 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Hitachi America, Ltd., Particle Therapy Division
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
| Date | Sep 12, 2024 (initiated May 27, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Between 08/05-09/2024, the firm communicated/hand-delivered an "URGENT: MEDICAL DEVICE RECALL" letter to customers informing them that during positioning in the Positioning Image Analysis Systems (PIAS) 3D3D matching mode, while transferring Cone Beam CT systems (CBCT) images from CT Image Reconstruction Software (CIRS) to PIAS, when the Float Image Selection button on the PIAS screen is pressed, it may display CBCT images that are insufficient in number. This may reveal a clear displacement in the Y-direction (body axis direction) compared to the planning CT. There may potentially be a |
| Quantity | 1 |
| Distribution | U.S. Nationwide distribution in the states of TN, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232032 | PROBEAT-FR Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, Jan 12, 2024 |