VIRTUAL INCISION CORPORATION: Device Recall
Recall #Z-1905-2025 · 04/23/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1905-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- VIRTUAL INCISION CORPORATION
- Status
- Completed
- Date Initiated
- 04/23/2025
- Location
- Lincoln, NE, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
Product Description
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Distribution Pattern
US Distribution to States: CA, FL, NE
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.