Class 2 Device Recall ORT200

• Date Initiated by Firm: August 06, 2026
• Date Posted: August 26, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3033-2026
• Recall Event ID: 99596
• Product Classification: Table, operating-room, ac-powered - Product Code FQO
• 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
• Code Information: 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
• FEI Number: 3010326005
• Recalling Firm/ Manufacturer: IMRIS Imaging Inc; 1230 Chaska Creek Way Ste 100; Chaska MN 55318-2707
• For Additional Information Contact: 763-203-6300
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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.
• Quantity in Commerce: 6 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.