Home / Recalls / LEONI CIA CABLE SYSTEMS / Z-0399-2024

Z-0399-2024 Class II Ongoing

Recalled by LEONI CIA CABLE SYSTEMS — Chartres, N/A

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: 3 units

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: 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 Pattern

US Nationwide distribution in the states of MA, TN.

Code Information

UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695