ORION System (LEONI) – Unintended Movement Risk (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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: 1SOPT00003
Brand
LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France
Lot Codes / Batch Numbers
UDI-DI: (01)03700383510017 SN: 100000001141
Products Sold
UDI-DI: (01)03700383510017 SN: 100000001141
LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France is recalling ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient posi due to Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
BizLink s notified customer via email with delivery and read confirmation and with the Field Safety Notice (FSCA Ref: UMCU-638) on October 6, 2023. Letter states reason for recall, health risk and action to take: BizLink technical support team will contact customers shortly to organize the deployment of the hot fix in the proton-therapy treatment centers. While waiting for the hot fix, BizLink recommend that customers implement the following action at the customer software level to avoid this problem: Send a stopFast command just after reactivating the motionEnable / the E-stop / the collision detection by Safety Laser and before sending any other motion command. A hot fix to correct this bug has been developed. BizLink shall provide this hot fix (version OSS 6.1 and version OSS 7.3) and the detailed documentation so that customers can deploy the new software version on clinical sites available on October 27, 2023 at the latest. If you require further clarification, please feel free to contact our BizLink Team (bfrc_CustomerName@bizlinktech.com). Please return the signed copy of the FSN to BizLink (bfr_vigilance_orion@bizlinktech.com) within 10 working days
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026