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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MIRA Surgical System Recalled for Software Lag and Motion Interruption

Agency Publication Date: June 4, 2025
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Summary

Virtual Incision Corporation has recalled three units of the MIRA Surgical System (Software Version 4.0.3) because of a software lag issue. This latency occurs between the surgeon's use of the hand controllers and the actual movement of the surgical robot arms, which can cause the motion on the display screen to appear jerky or interrupted. No injuries have been reported in connection with this issue.

Risk

The software delay can cause the surgical robot to move in an unpredictable or non-continuous manner, potentially leading to surgical errors, unintended tissue damage, or delays in critical procedures.

What You Should Do

  1. This recall affects the MIRA Surgical System, a table-mounted miniaturized electromechanical surgical system (Software Version 4.0.3), identified by Catalog Number MIRA-CAP-110 and UDI-DI 00850038042028.
  2. Check for lot numbers 1020040211, 1020040212, and 1020040213 to determine if your surgical system is included in this recall.
  3. Stop using the recalled device immediately to avoid the risk of software latency during surgical procedures.
  4. Contact Virtual Incision Corporation or your distributor directly to arrange for a software correction, device return, or replacement.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MIRA SURGICAL SYSTEM (Software Version 4.0.3)
Variants: Table mounted miniaturized electromechanical surgical system
Model / REF:
MIRA-CAP-110
Lot Numbers:
1020040211
1020040212
1020040213
UDI:
00850038042028

Software Version 4.0.3 loaded on the Surgeon Control Console.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96831
Status: Resolved
Manufacturer: VIRTUAL INCISION CORPORATION
Sold By: Virtual Incision Corporation
Manufactured In: United States
Units Affected: 3 units
Distributed To: California, Florida, Nebraska

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.