Reported Jun 11, 2025 · Completed

MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110,…

Virtual Incision Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: VIRTUAL INCISION CORPORATION · 1501 Old Cheney Rd · Lincoln, NE · 68512-2505

Is this the product you have?

  • MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Lot codes and dates
  • UDI-DI (01)00850038042028
  • Lot Numbers
    • 1020040211
    • 1020040212
    • 1020040213
Amount recalled
3 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:37 PM UTC

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