FDAFDA · Food and drugs·Recall number Z-1905-2025
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Published June 11, 2025 · Recall initiated: April 23, 2025
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VIRTUAL INCISION CORPORATION
- Distributor
- US Distribution to States: CA, FL, NE
- Lot
- UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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