LEONI CIA CABLE SYSTEMS recalls ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiatio…

Recall date

October 6, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0398-2024

FDA classification

Class II

Brand / firm

LEONI CIA CABLE SYSTEMS

Sold / distributed

US Nationwide distribution in the states of MA, TN.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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