Device product
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Z-1905-2025
Product summary
- Event
- Event 96831
- Status
- Completed
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1905-2025
Official wording
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.
Code information: UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
Distribution pattern: US Distribution to States: CA, FL, NE
Derived failure modes
-
Device software or design
Software Version 4.0.3 loaded on the Surgeon Control Console may