FDA recall Z-0399-2024

LEONI CIA CABLE SYSTEMS · Class II · 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

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

US Nationwide distribution in the states of MA, TN.

Key facts

Status
Ongoing
Initiation date
2023-10-06
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chartres, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2024