Siemens recalls certain digital linear accelerators where disabling the AMP function may cause patient or user injury due to collision with LINAC equipment. Affected units include ARTISTE, ONCOR, and PRIMUS models with specific software versions.
Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
Siemens is recalling certain medical linear accelerators that could cause patient or user injury if the AMP (Automatic Motion Protection) function is disabled. This risk occurs when the function is bypassed for comfort, potentially leading to collisions with the LINAC equipment.
Disabling or bypassing the AMP function for comfort can cause the linear accelerator to lose its automatic motion protection. This may result in the patient or user colliding with the LINAC equipment, causing injury.
Medical facilities using Siemens ARTISTE, ONCOR, or PRIMUS linear accelerators with specific software versions are affected. Patients and staff at these facilities are at risk if the AMP function is disabled.
Check if your Siemens linear accelerator model is ARTISTE, ONCOR, or PRIMUS. Look for specific software versions: 13.0.302 or higher, 9.2.400 or higher, or 11.0.400 or higher on the control console.
Verify the software version on your control console to see if it matches the affected versions listed in the recall.
Disabling or bypassing the AMP function can cause the linear accelerator to lose automatic motion protection, potentially leading to patient or user injury from collisions with LINAC equipment.
Control consoles with software versions 13.0.302 or higher, 9.2.400 or higher, or 11.0.400 or higher are affected.
No, but you should check the software version and ensure the AMP function is not disabled or bypassed for comfort.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1204-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1204-2019 from Siemens. 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.
