VIRTUAL INCISION CORPORATION recalls MIRA SURGICAL SYSTEM

The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.

MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

A "MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 4/22/25 was sent to customers. Actions to be taken by the Customer/User: Do not use the device and transition scheduled procedures to another minimally invasive surgical technique i.e. laparoscopic or other robotic assisted device. Remove the device from service using your internal institutional procedures (e.g. Lock-Out, Tag-Out) for device maintenance until Virtual Incision technicians service the devices on hand. There is no anticipated impact to the conduct of the clinical study under the IDE. Please complete the attached Acknowledgement and Receipt form and return to Virtual Incision to indicate you received this letter. Customer Service, Clinical Support Staff, abby.cooper@virtualincision.com,913-608-3214. Quality Assurance, Sr Director of Quality and Manufacturing Engineering, Brandon.williams@virtualincision.com, 308-529-1987. Regulatory Affair, VP of Clinical and Regulatory Affairs, Florence.Beck@virtualincision.com, 352-275-726. Type of Action by the Company: Virtual Incision will be working with your site representatives to schedule on-site servicing of the device with updated software for the Surgeon Control Console within 30 days from receipt of this letter. Immediate corrections have been implemented through the analysis of the system data. Results indicate that implemented software updates have resolved the issue that could contribute to this deficiency in the future. If you have any question, call 513-500-4459 or email: mirasupport@virtualincision.com.

• FDA enforcement recordOfficial FDA database entry for Z-1905-2025
• FDA device classification · SABOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4962The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find VIRTUAL INCISION CORPORATIONSearch 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.