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Recall Observatory FDA recall evidence

Device product

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

Z-1905-2025

April 23, 2025

Class II

Product summary

Firm
VIRTUAL INCISION CORPORATION
Event
Event 96831
Status
Completed
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-1905-2025

Official wording

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.

Code information: UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213

Distribution pattern: US Distribution to States: CA, FL, NE

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software Version 4.0.3 loaded on the Surgeon Control Console may