FDAApril 23, 2025device
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Completed
Brands named
virtual incisionvirtual
UPCs
00850038042028
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAvRad PACS with Mammography2023-05-09
- FDARadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the...2018-11-02
- FDADigital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.2014-09-22
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