Recall archive / FDA device enforcement
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiat... — FDA record Z-0398-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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: 1SOPT00003
- 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.
- Classification
- Class II
- Recalling firm
- LEONI CIA CABLE SYSTEMS
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0398-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: (01)03700383510017 SN: 100000001141 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of MA, TN.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 29, 2023
- Recall initiation date
- Oct 6, 2023
- Center classification date
- Nov 21, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.