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

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.

Details from the source

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 Quantity: 3 units Lot/code info: UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213

UPC codes

00850038042028

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.