[pending] MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number M
Pending LLM rewrite. Source: FDA_DEVICE Z-1905-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
- Manufacturer
- VIRTUAL INCISION CORPORATION
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI (01)00850038042028
- Lot Numbers: 1020040211
- 1020040212
- 1020040213
Distribution
Distributed in 3 states:
- CA
- FL
- NE
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