IMRIS Imaging Inc — Class II: ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000
IMRIS Imaging Inc has initiated a Class II recall for the ORT300 Modular Table Main Unit Assy due to potential mechanical failure of the linear actuator and rotational lock mechanism. This failure may prevent the system from transitioning between locked and unlocked states, potentially causing unintended rotational movement.
This affects IMRIS Imaging Inc, surgical facilities utilizing the ORT300 operating room table system, and hospital maintenance/biomedical engineering departments responsible for surgical equipment upkeep.
The failure of locking mechanisms in a surgical environment presents a risk of patient injury during procedures requiring table stability. From a regulatory perspective, this indicates a mechanical reliability issue that likely necessitates CAPA investigation into component durability or supplier quality for the linear actuators and locking assemblies.
Identify and quarantine affected main unit assemblies (Part Numbers 114093-000 and 114093-600). Conduct a review of maintenance logs for linear actuator or rotational lock issues and ensure clinical staff are trained on emergency procedures for unintended table movement.
Class II. Reason: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.. Product: ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600. Firm: IMRIS Imaging Inc (Chaska MN United States). Status: Ongoing.
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