LEONI recalls Orion System with software v6.0 and v7.0 due to potential patient collisions from unintended movements. Affected units include specific serial numbers sold in radiation therapy environments.
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 recalls its Orion patient positioning system software versions v6.0 and v7.0 because unintended movements could cause patient collisions in treatment rooms. This risk affects radiation therapy and radiology environments where the system is used.
The software may cause sudden unintended movements after an interruption signal, potentially leading to patient collisions with stationary equipment in the treatment room. This could happen during patient positioning procedures in radiation therapy environments.
Healthcare providers using the Orion System in radiation therapy or radiology settings are most at risk. Patients undergoing treatment with this system could be affected if the software issue occurs.
Check for the Orion System with software versions v6.0 or v7.0. Serial numbers include SN 100000004639, SN 100000004698, and SN 100000004695 as listed in the recall notice.
Verify if your Orion System uses software versions v6.0 or v7.0 by checking the system's software version in the treatment room.
Reach out to LEONI CIA CABLE SYSTEMS for specific guidance on whether your unit requires action.
Software versions v6.0 and v7.0 of the Orion System are affected.
Check for serial numbers SN 100000004639, SN 100000004698, or SN 100000004695 as listed in the recall notice.
The recall does not require immediate stop use; healthcare providers should check software versions and contact LEONI for guidance.
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-0399-2024 — LEONI CIA CABLE SYSTEMS LEONI CIA CABLE SYSTEMS Hello, I own a LEONI CIA CABLE SYSTEMS that is covered by recall Z-0399-2024 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.
