PlainRecalls
FDA Devices Moderate 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: 1SOPT00003

Reported: November 29, 2023 Initiated: October 6, 2023 #Z-0398-2024

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.

Details

Recalling Firm
LEONI CIA CABLE SYSTEMS
Units Affected
1 unit
Distribution
US Nationwide distribution in the states of MA, TN.
Location
Chartres, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by LEONI CIA CABLE SYSTEMS. Units affected: 1 unit.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0398-2024.