FDA-Device2025-06-11Class II

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

VIRTUAL INCISION CORPORATION
Hazard

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.

Sold states
US Distribution to States: CA, FL, NE
Affected count
3 units
Manufactured in
1501 Old Cheney Rd, N/A, Lincoln, NE, United States
Products
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1905-2025

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