FDAFDA · Food and drugs·Recall number Z-1424-2013
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.
Published June 5, 2013 · Recall initiated: January 24, 2013
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
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- US Distribution Only
- Lot
- Model number 552002-01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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