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LEONI CIA CABLE SYSTEMS recalls ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation
Recalled November 29, 2023 · FDA recall Z-0399-2024 · LEONI CIA CABLE SYSTEMS
Hazard
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. · FDA Class II
Units
3 units
Sold at
US Nationwide distribution in the states of MA, TN.
Description
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.
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(s)
LEONI CIA CABLE SYSTEMS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →