Company: Virtual Incision Corporation
Date of Enforcement Report: 6/4/2025
Class: II
PRODUCT
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Recall Number:
Z-1905-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
VIRTUAL INCISION CORPORATION
VOLUME:
3 units
DISTRIBUTION:
US Distribution to States: CA, FL, NE
