MIRA SURGICAL SYSTEM — Class II medical device recall Z-1905-2025
Completed recall by VIRTUAL INCISION CORPORATION, reported 2025-06-11, distributed in CA, FL, NE. The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential t
| Recall number | Z-1905-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | VIRTUAL INCISION CORPORATION, Lincoln, NE, United States |
| Recall initiated | 2025-04-23 |
| Classified | 2025-06-04 |
| Reported by FDA | 2025-06-11 |
| Distributed | CA, FL, NE |
| Quantity | 3 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00850038042028 |
| Lot numbers | 1020040211, 1020040212, 1020040213 |
| Model numbers | MIRA-CAP-110 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1905-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.