FDA Enforcement
Class II
Ongoing
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
Recall: Z-0399-2024
·
Reported November 29, 2023
Enforcement
- Recall Number
- Z-0399-2024
- Event ID
- 93315
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- LEONI CIA CABLE SYSTEMS
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 29, 2023
- Initiation Date
- October 6, 2023
- Classification Date
- November 21, 2023
- Address
- 5 avenue Victor Hugo, N/A, Chartres, N/A, N/A, France
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: 1SOPT00009
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 Info
UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
Distribution
US Nationwide distribution in the states of MA, TN.
Quantity
3 units