Device 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
Z-0399-2024
Product summary
- Event
- Event 93315
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0399-2024
Official wording
Reason: 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.
Code information: UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
Distribution pattern: US Nationwide distribution in the states of MA, TN.
Derived failure modes
-
Unknown
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.