Hitachi recalls PROBEAT-FR proton therapy systems that may display insufficient CBCT images during 3D matching mode, requiring immediate action to prevent treatment errors.
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 is recalling its PROBEAT-FR proton therapy systems because they may display insufficient CBCT images during 3D matching mode. This could lead to treatment errors if the system is used without proper image verification.
When the Float Image Selection button is pressed during 3D to 3D matching mode for CBCT images, the system may display fewer images than needed. This could result in incomplete treatment planning if the system is used without verifying the image count.
Medical facilities using the PROBEAT-FR proton therapy system for cancer treatment are likely affected. Patients receiving proton therapy at these facilities are at risk of treatment errors.
The PROBEAT-FR is a proton beam irradiation system used for cancer treatment. It was sold by Hitachi America, Ltd., Particle Therapy Division with the component code PTFR-01.
Check if the system displays insufficient CBCT images during 3D matching mode when the Float Image Selection button is pressed.
The recall affects medical facilities using the PROBEAT-FR system, but patients are not directly affected unless their treatment is impacted by the system error.
Check if your system displays insufficient CBCT images during 3D matching mode when the Float Image Selection button is pressed.
The recall does not specify a remedy, so contact Hitachi America, Ltd., Particle Therapy Division for guidance.
We’ve drafted a message you can send Hitachi to request your refund or repair — edit it as you like.
Subject: Recall Z-3125-2024 — Hitachi Hitachi Hello, I own a Hitachi that is covered by recall Z-3125-2024 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.
