LEONI CIA CABLE SYSTEMS: Medical Device Recall in 2023 - (Recall #: Z-0398-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 6, 2023

Date Posted: November 29, 2023

Recall Number: Z-0398-2024

Event ID: 93315

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.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

UDI-DI: (01)03700383510017 SN: 100000001141

Distribution Pattern:

US Nationwide distribution in the states of MA, TN.

Voluntary or Mandated:

Voluntary: Firm initiated