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U.S. Department of Health and Human Services

Class 2 Device Recall ORION System

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  Class 2 Device Recall ORION System see related information
Date Initiated by Firm October 06, 2023
Date Posted November 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-0399-2024
Recall Event ID 93315
510(K)Number K160518  
Product Classification Couch, radiation therapy, powered - Product Code JAI
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
Code Information UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
Recalling Firm/
Manufacturer		 LEONI CIA CABLE SYSTEMS
5 avenue Victor Hugo
Chartres France
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action 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
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the states of MA, TN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAI and Original Applicant = LEONI CIA CABLE SYSTEM
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