Mira Surgical System recall: Software Issue
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Why was Mira Surgical System 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 I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
- Product
- MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
- Recalling firm
- VIRTUAL INCISION CORPORATION
- Quantity
- 3 units
- Distribution
- US Distribution to States: CA, FL, NE
- Recall date
- June 11, 2025
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)