🔍 RecallPedia

User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.

Class I - Dangerous
🏥 Medical Devices Recalled: January 24, 2013 Intuitive Surgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Model number 552002-01
  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:
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.

Product Codes/Lot Numbers:

Model number 552002-01

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1424-2013

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