Hitachi recalls PROBEAT-V proton therapy systems that may display insufficient CBCT images during 3D matching mode, potentially affecting treatment accuracy. Affected units require immediate review by your healthcare provider.
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.
Hitachi's PROBE:AT-V proton therapy system may show insufficient CBCT images during positioning, which could affect treatment accuracy. Patients using this system should contact their healthcare provider to review their specific situation.
When the Float Image Selection button is pressed during 3D to 3D matching mode for CBCT images, the system may display insufficient images. This could lead to inaccurate treatment planning if the system fails to properly match the patient's anatomy.
Patients using the PROBEAT-V proton therapy system for cancer treatment. Those with the system's serial number starting with 2015B01 are most at risk.
The PROBEAT-V system has a serial number starting with 2015B01. This product is used for proton beam therapy in cancer treatment.
Your healthcare provider should review the system's performance to ensure treatment accuracy.
The recall may affect treatment accuracy if the system displays insufficient CBCT images. Your healthcare provider should review your specific case.
Check if your PROBEAT-V system has a serial number starting with 2015B01.
Contact your healthcare provider to review the system's performance and ensure treatment accuracy.
We’ve drafted a message you can send Hitachi to request your refund or repair — edit it as you like.
Subject: Recall Z-3127-2024 — Hitachi Hitachi Hello, I own a Hitachi that is covered by recall Z-3127-2024 from Hitachi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
