Recall Z-0399-2024— LEONI CIA CABLE SYSTEMS
Class II · Ongoing
Class II FDA medical device recall by LEONI CIA CABLE SYSTEMS, initiated 2023-10-06. It names one FDA 510(k) clearance: K160518. 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. 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..
- Recalling firm
- LEONI CIA CABLE SYSTEMS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-06
- Firm location
- Chartres, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.