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
This recall is currently active, issued November 21, 2023. It was issued by Leoni Cia Cable Systems 5 Avenue Victor Hugo Chartres France.
- Recall Initiated
- October 6, 2023
- Posted
- November 21, 2023
- Recall Number
- Z-0399-2024
- Quantity
- 3 units
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
Root Cause
Software design
Action Taken
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