Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ORION System with software OSS v6.0 and OSS v7.0- An Recalled by LEONI CIA CABLE SYSTEMS Due to Users of the patient positioning system ORION System...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LEONI CIA CABLE SYSTEMS directly.
Affected Products
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
Quantity: 3 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LEONI CIA CABLE SYSTEMS
LEONI CIA CABLE SYSTEMS has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report