# FDA recall Z-0399-2024

> **LEONI CIA CABLE SYSTEMS** · Class II · device recall initiated 2023-10-06.

## 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

- **Recall number:** Z-0399-2024
- **Recalling firm:** LEONI CIA CABLE SYSTEMS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-06
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chartres, N/A, France

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0399-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0399-2024. Source: US FDA. Licensed CC0.

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