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
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- LEONI CIA CABLE SYSTEMS
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0399-2024
Related Recalls
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: 1SOPT00003
LEONI CIA CABLE SYSTEMS
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.