MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
VIRTUAL INCISION CORPORATION
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

Product Codes/Lot Numbers:

UDI-DI (01)00850038042028; Lot Numbers: 1020040211, 1020040212, 1020040213

Distribution:

Distributed in: US, CA, FL, NE

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1905-2025