VIRTUAL INCISION CORPORATION recalls MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Softwa…

Recall date

April 23, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1905-2025

FDA classification

Class II

Brand / firm

VIRTUAL INCISION CORPORATION

Sold / distributed

US Distribution to States: CA, FL, NE

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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