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U.S. Department of Health and Human Services

Class 2 Device Recall MIRA SURGICAL SYSTEM

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 Class 2 Device Recall MIRA SURGICAL SYSTEMsee related information
Date Initiated by FirmApril 23, 2025
Date PostedJune 04, 2025
Recall Status1 Completed
Recall NumberZ-1905-2025
Recall Event ID 96831
Product Classification Table Mounted Miniaturized Electromechanical Surgical System - Product Code SAB
ProductMIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Code Information UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
FEI Number 3030285773
Recalling Firm/
Manufacturer		 VIRTUAL INCISION CORPORATION
1501 Old Cheney Rd
Lincoln NE 68512-2505
For Additional Information ContactFlorence Beck
1-531-5004459
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionA "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.
Quantity in Commerce3 units
DistributionUS Distribution to States: CA, FL, NE
Total Product Life CycleTPLC 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.
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