FDAFDA · Food and drugs·Recall number Z-1429-2013
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Published June 5, 2013 · Recall initiated: September 19, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Clarification of existing labeling information and operating procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
- Lot
- Model number: 314850, versions 1-6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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