FDA Medical devices recall ·
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical… recall
- Recall number
- Z-1905-2025
- Date
- (initiated April 23, 2025)
- Company / brand
- Virtual Incision Corporation
1501 Old Cheney Rd, Lincoln, NE, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 3 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
Distribution
US Distribution to States: CA, FL, NE
States: California Florida Nebraska
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1905-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.