da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part number 372012-96: Serial numbers: 323986 324198.
  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:
Intuitive Surgical, Inc.
Reason for Recall:
Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.

Product Codes/Lot Numbers:

Part number 372012-96: Serial numbers: 323986 324198.

Distribution:

Distributed in: UT, CA, AZ, CO, FL, HI, MT, NY, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1689-2013

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