MIRA Surgical System software update recall for motion display issue
Virtual Incision Corporation is recalling MIRA Surgical System units with Software Version 4.0.3 due to potential interrupted motion on the surgeon control console display caused by software latency.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a software latency issue affecting display functionality—a technical malfunction without documented patient harm or high-risk pathogen contamination.
Plain-English summary
Virtual Incision Corporation is recalling the MIRA Surgical System (Catalog Number MIRA-CAP-110, Software Version 4.0.3) due to a software issue. The Software Version 4.0.3 loaded on the Surgeon Control Console may exhibit interrupted motion on the display screen, caused by software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.
Three units have been distributed in the United States to California, Florida, and Nebraska. The affected lot numbers are 1020040211, 1020040212, and 1020040213.
Users of this system should contact Virtual Incision Corporation for further instructions regarding this recall.
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
- Affected units
- 3
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
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