FDAOctober 6, 2023device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
leoni cia cable systemsleonileoni cia
UPCs
03700383510079100000004639100000004698100000004695
Recall history
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