MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Softwar
Summary
The FDA issued a Class II for MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical syst by VIRTUAL INCISION CORPORATION. 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 disp.
Details
Source
Device Recall
External ID
Z-1905-2025
Action Date
2025-06-11
Status
Completed
Category
device
Product Description
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Lot/Code Info: UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
Quantity Affected: 3 units
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
US Distribution to States: CA, FL, NE
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-23
Company
Lincoln, NE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VIRTUAL INCISION CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VIRTUAL INCISION CORPORATION have FDA actions?
This is the only FDA action we have on record for VIRTUAL INCISION CORPORATION in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1905-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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