ORION System with software OSS v6 — Class II medical device recall Z-0399-2024
Ongoing recall by LEONI CIA CABLE SYSTEMS, reported 2023-11-29, distributed nationwide. Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or wit
| Recall number | Z-0399-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEONI CIA CABLE SYSTEMS, Chartres, N/A, France |
| Recall initiated | 2023-10-06 |
| Classified | 2023-11-21 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 03700383510079 |
| Model numbers | 1SOPT00009 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0399-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.