Vision RT recalls specific Integrated Gate Controller PCB components for AlignRT Plus Truebeam systems due to RTInterface errors during I/O communication. Affected units have serial numbers starting with 248- or 249-.
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
Vision RT is recalling certain Integrated Gate Controller PCB components used in AlignRT Plus Truebeam systems. This recall is due to a potential RTInterface error that could cause communication issues between the IGC PCB and Framegrabber PCB during radiotherapy imaging.
The recall addresses a potential RTInterface error that could occur during I/O communication between the Integrated Gate Controller PCB and Framegrabber PCB. This error may cause the system to malfunction during 3D surface imaging of patients for radiotherapy treatment.
Patients receiving radiotherapy using the AlignRT Plus Truebeam system with the recalled PCB components are most at risk. The affected units have specific serial numbers starting with 248- or 249-.
Check if your AlignRT Plus Truebeam system has an Integrated Gate Controller PCB with serial numbers starting with 248- or 249- as listed in the recall. The specific serial numbers are provided in the recall notice.
Verify if your AlignRT Plus Truebeam system uses the recalled Integrated Gate Controller PCB with serial numbers starting with 248- or 249- as listed in the recall.
The recall states there is an RTInterface error that could occur during I/O communication between the Integrated Gate Controller PCB and Framegrabber PCB.
Check if your system has an Integrated Gate Controller PCB with serial numbers starting with 248- or 249- as listed in the recall notice.
No action is required if your system does not have the affected serial numbers listed in the recall.
We’ve drafted a message you can send Vision RT to request your refund or repair — edit it as you like.
Subject: Recall Z-0065-2019 — Vision RT Vision RT Hello, I own a Vision RT that is covered by recall Z-0065-2019 from Vision RT. 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.
