Robotic patient positioning system may move unexpectedly after interruption
The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm product (potential collision) where no illnesses or injuries have been reported. Per the rubric, theoretical hazards without reported harm score at most 3.
Plain-English summary
The FDA has issued a Class II recall for the ORION System, an electro-mechanical robotic arm used for patient positioning in radiation therapy, radiology, and image-guided treatment environments. The device may experience sudden short-term acceleration or unintended movement when motion resumes following an unforeseen interruption signal.
This malfunction poses a potential risk of collision between the patient and stationary components of the treatment room during medical procedures.
The recall affects units distributed in Massachusetts and Tennessee. The recalled device is identified by Part Number 1SOPT00003 with software versions OSS v6.0 and OSS v7.0, and carries UDI-DI (01)03700383510017.
Users of this system should contact the manufacturer, LEONI CIA CABLE SYSTEMS, for guidance on remediation or safety measures.
The recalled product
- 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
- Manufacturer
- LEONI CIA CABLE SYSTEMS
- Hazard
- sudden-acceleration
- unintended-movement
- collision-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)03700383510017 SN: 100000001141
Distribution
Distributed nationwide across the United States.
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