MIRA Surgical System (Virtual Incision) – Motion Interruption (2025)
Software latency can cause interruption in surgical minibot arm movement.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Brand
VIRTUAL INCISION CORPORATION
Lot Codes / Batch Numbers
UDI-DI (01)00850038042028, Lot Numbers: 1020040211, 1020040212, 1020040213
Products Sold
UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
VIRTUAL INCISION CORPORATION is recalling MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number M due to 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 disp. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, NE
Page updated: Jan 10, 2026