FDA Medical Device Recalls (openFDA)
LEONI CIA CABLE SYSTEMS: 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
- Recall number
- Z-0399-2024
- Recalling firm
- LEONI CIA CABLE SYSTEMS
- 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
- Status
- Open, Classified
- Initiated
- 2023-10-06
- Posted
- 2023-11-21
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 3 units
- Distribution
- US Nationwide distribution in the states of MA, TN.
- Lot, serial or model codes
- UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
- 510(k) numbers
- ["K160518"]
- PMA numbers
- not on file
- Product code
- JAI
- Firm FEI
- 3012834372
- Firm city
- Chartres
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28