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FDA (Device enforcement)Recalled 2023-10-06class ii

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: 1 unit Lot/code info: UDI-DI: (01)03700383510017 SN: 100000001141

UPC codes

03700383510017, 100000001141

Source

Official record: FDA (Device enforcement)

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

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