IMRIS Imaging Inc recalls ORT300

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.

An URGENT: MEDICAL DEVICE RECALL notification letter dated 8/6/26 was sent to customers. IMRIS recommends the following preventative actions until the corrective actions have been implemented on your table: " Per the OR Table Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, tabletops, headrest, pendant connection and rotation. " During usage, verify the table position is locked by manually pushing the table to ensure it does not exhibit rotational movement. " If the floor latching mechanism is observed to not function properly, please contact IMRIS Customer Service immediately. Please confirm receipt of this notice with IMRIS using the Customer Acknowledgement Form below, and please forward this communication to any others inside or outside your organization who may work with the affected ORT200 and ORT300 tables. To minimize the potential risk of injury, IMRIS is taking the following corrective actions: " The existing ORT200 and ORT300 linear actuator and rotational lock mechanism components will be replaced with an updated design. Our customer service organization will contact you to make arrangements for IMRIS field service personnel to perform the correction at your facility. IMRIS has identified that your facility has one or more ORT200 or ORT300 Operating Tables which are subject to this recall notice. Please confirm details on the last page of this letter and return your response to IMRIS. IMRIS Customer Service will contact you to facilitate replacement of the linear actuator and rotational lock mechanism components at your facility. Please contact our customer support team through our service line at 1-866-475-0525 or e-mail: customersupport@imris.com if you have any questions or concerns. Please keep this information until the corrective measures have been finalized.

• FDA enforcement recordOfficial FDA database entry for Z-3034-2026
• FDA device classification · KXJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1980The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find IMRIS Imaging IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.