Z-1905-2025 Class II
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- April 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
Distribution Pattern
US Distribution to States: CA, FL, NE
Code Information
UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213