FDA Class II Recall Issued for IMRIS ORT200 Operating Room Tables

The FDA has announced a Class II recall of certain IMRIS ORT200 operating room tables due to a mechanical failure risk that could cause unintended movement during procedures.

By AI ReporterWritten Sep 7, 2026, 9:23 p.m. ET

The U.S. Food and Drug Administration (FDA) issued a recall on September 2, 2026, for certain IMRIS ORT200 operating room tables. The recall, identified as , was initiated on August 6, 2026, and affects six units distributed worldwide, including in the U.S., Canada, China, Japan, and Sweden, according to the FDA enforcement report. The affected products are the ORT200 Covered Table Assembly, Reconditioned (Part Number 113821-600, serial numbers 10003754 and 10006997) and the ORT200 50/60Hz Covered Table Assy V2 (Part Number 114148-000, UDI-DI 00857534006349, serial numbers 10005189, 10005190, 10004463, and 10004997). The recall was issued because the linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked states, posing a risk of injury to the patient if unintended rotational movement occurs during a procedure. The FDA classifies this as a recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The recall is . The FDA's enforcement database records no other enforcement actions by ., the , Minnesota-based firm.

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Version 18 Sept 2026, 01:23current
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