FDA recall Z-1905-2025

VIRTUAL INCISION CORPORATION · Class II · device

Product

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

Reason for recall

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.

Distribution

US Distribution to States: CA, FL, NE

Key facts

Status: Completed
Initiation date: 2025-04-23
Report date: 2025-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lincoln, NE, United States

Primary source

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