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
This recall is currently active, issued September 12, 2024. It was issued by Hitachi America, Ltd., Particle Therapy Division.
- Recall Initiated
- May 27, 2024
- Posted
- September 12, 2024
- Recall Number
- Z-3127-2024
- Quantity
- 1
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
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
U.S. Nationwide distribution in the states of TN, TX, and WA.
Lot / Code Info
Lot Code: This products has no UDI. Serial No.: 2015B01
Root Cause
Software design
Action Taken
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 possibility of completing 3D3D patient positioning approximately 5mm off in the body axis direction (with 5 images missing) and proceeding with treatment. Customers are instructed, until the software has been replaced with the corrected version, all users of the device are directed to follow the interim countermeasure. When users operate as described in the operation manual, no such event should occur. Countermeasure references: Engineering Document: PBT-40E-1042 Instruction for patient positioning assistance using CBCT [PROBEAT-FR] Operation Manual TS.16F0147-1 Page.1-105 / 1-108 [PROBEAT-CR] Operation Manual TS.16F0147-1 Page. 1-4-20 / 1-4-23 [PROBEAT-V] Operation Manual TS.16A1850-1E Page.1-126 / 1-131 For questions/assistance -