LEONI recalls Orion System software versions v6.0 and v7.0 due to potential patient collisions from unintended movements after motion interruptions. Affected units include specific part numbers and serial numbers.
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
LEONI is recalling Orion System software versions v6.0 and v7.0 used in medical imaging. The software may cause unintended patient movements after motion interruptions, risking collisions with stationary equipment in treatment rooms.
The software may cause the robotic arm to move unexpectedly after an interruption signal stops motion. This could lead to the patient colliding with stationary equipment in the treatment room, potentially causing injury.
Healthcare providers using the Orion System for radiation therapy or radiology imaging are most at risk. Patients in treatment rooms could be affected if the system malfunctions.
Check for part number 1SOPT00003 or serial number starting with 100000001141. The software versions v6.0 and v7.0 are used in radiation therapy, radiology, or image-guided treatment environments.
Verify if your Orion System uses software versions v6.0 or v7.0 by checking the device's software version in the treatment room.
Software versions v6.0 and v7.0 of the Orion System.
The software may cause unintended patient movements after motion interruptions, potentially leading to collisions with stationary equipment in the treatment room.
Check for part number 1SOPT00003 or serial number starting with 100000001141. The affected software versions are v6.0 and v7.0.
We’ve drafted a message you can send LEONI CIA CABLE SYSTEMS to request your refund or repair — edit it as you like.
Subject: Recall Z-0398-2024 — LEONI CIA CABLE SYSTEMS LEONI CIA CABLE SYSTEMS Hello, I own a LEONI CIA CABLE SYSTEMS that is covered by recall Z-0398-2024 from LEONI CIA CABLE SYSTEMS. 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.
