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 treatmen

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the states of MA, TN. Quantity: 3 units Lot/code info: UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695

UPC codes

03700383510079, 100000004639, 100000004698, 100000004695

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.