Official recall record
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology,
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-10-06
- Country of alert
- France
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 03700383510017
- Brand on record
- LEONI CIA CABLE SYSTEMS
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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