FDA-Device2023-11-29Class II
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
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.
Sold states
US Nationwide distribution in the states of MA, TN.
Affected count
3 units
Manufactured in
5 avenue Victor Hugo, N/A, Chartres, N/A, France
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2024Don't want to check this manually?
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