IMRIS Imaging Inc — Class II: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned,
IMRIS Imaging Inc has initiated a Class II recall for reconditioned ORT200 operating room tables 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 leading to unintended rotational movement.
This recall affects IMRIS Imaging Inc, surgical facilities utilizing the ORT200 and ORT200 50/60Hz Covered Table Assemblies (Part Numbers 113821-600 and 114148-000), and clinical staff responsible for intraoperative table positioning.
Mechanical failures in surgical table locking mechanisms present a direct risk of patient injury during procedures. From a regulatory perspective, this suggests a need for heightened scrutiny of the supply chain and quality control processes for reconditioned medical equipment, specifically regarding the fatigue life or reliability of mechanical actuators. Operations teams may need to prepare for service interruptions or equipment replacement while the 'Ongoing' recall status is resolved.
Inventory management should immediately identify and sequester affected part numbers (113821-600 and 114148-000). Quality teams should review maintenance logs for linear actuator or lock mechanism malfunctions and ensure all reconditioned units are assessed for mechanical integrity in accordance with the manufacturer's upcoming remediation instructions.
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: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000. Firm: IMRIS Imaging Inc (Chaska MN United States). Status: Ongoing.
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