da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model number: 314850, versions 1-6
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Clarification of existing labeling information and operating procedures.
- 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 Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Product Codes/Lot Numbers:
Model number: 314850, versions 1-6
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1429-2013
Related Recalls
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments