Z-0398-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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: 1SOPT00003
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of MA, TN.
Code Information
UDI-DI: (01)03700383510017 SN: 100000001141