ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk
The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves risk-of-harm in a critical clinical setting where patients could be injured by unintended motion and collision. Though no injuries have been reported to date, the potential for serious patient harm meets the criterion for High severity.
Plain-English summary
The FDA is recalling the ORION System with software versions OSS v6.0 and OSS v7.0, an electro-mechanical robotic arm used for patient positioning in radiation therapy, radiology, and image-guided treatment procedures.
The recall is due to a motion control issue. After an unforeseen interruption of the robotic arm's movement, when motion resumes, the system may suddenly accelerate or execute an unintended short-distance movement. This could result in the patient colliding with stationary components of the treatment room.
Three units have been identified with this defect and distributed nationwide in Massachusetts and Tennessee. The affected serial numbers are 100000004639, 100000004698, and 100000004695.
No injuries or adverse events have been reported to date. Healthcare facilities using this equipment should contact LEONI CIA CABLE SYSTEMS for guidance on remediation or replacement options.
The recalled product
- Product
- ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
- Manufacturer
- LEONI CIA CABLE SYSTEMS
- Hazard
- unintended-motion
- collision-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
Distribution
Distributed nationwide across the United States.
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