Recall Z-1905-2025— VIRTUAL INCISION CORPORATION
Class II · Completed
Class II FDA medical device recall by VIRTUAL INCISION CORPORATION, initiated 2025-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3. Reason: 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..
- Recalling firm
- VIRTUAL INCISION CORPORATION
- Classification
- Class II
- Status
- Completed
- Initiated
- 2025-04-23
- Firm location
- Lincoln, NE, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.