Hitachi America recalls PROBEAT-CR proton therapy systems that may display insufficient CBCT images during 3D matching mode, potentially affecting treatment accuracy. Affected units require specific verification.
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 PROBEAT-CR proton therapy systems that may display insufficient CBCT images during 3D matching mode. This could lead to inaccurate radiation treatment planning if not corrected.
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 radiation treatment planning if the system does not show enough images to properly target the tumor.
Medical facilities using the PROBEAT-CR proton therapy system for cancer treatment. Patients receiving therapy with this system are most at risk if the imaging issue affects treatment planning.
The PROBEAT-CR proton therapy system with the component code (01)04560333350006(21)CRUS01(11)190920. This system is used in medical facilities for cancer treatment.
Check if the system displays insufficient CBCT images during 3D matching mode when the Float Image Selection button is pressed.
The recall applies to medical facilities using the PROBEAT-CR system. Patients are affected indirectly if the system's imaging issue impacts treatment planning.
Check for the component code (01)04560333350006(21)CRUS01(11)190920 on the system. This is specific to the recalled version.
Verify if the system displays insufficient CBCT images during 3D matching mode when the Float Image Selection button is pressed. No immediate action is required beyond this check.
We’ve drafted a message you can send Hitachi to request your refund or repair — edit it as you like.
Subject: Recall Z-3126-2024 — Hitachi Hitachi Hello, I own a Hitachi that is covered by recall Z-3126-2024 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.
