Recall Z-0399-2024 ยท JAI Couch, Radiation Therapy, Powered
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
| Date | Nov 21, 2023 (initiated Oct 6, 2023) |
| Status | Open, Classified |
| 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 collisio |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of MA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160518 | LEONI ORION System Leoni Cia Cable System, Jul 14, 2016 |