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.
Reported: June 5, 2013 Initiated: January 24, 2013 #Z-1424-2013
Product 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.
Reason for Recall
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 1,374
- Distribution
- US Distribution Only
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Intuitive Surgical, Inc.. Units affected: 1,374.
Why was this product recalled? ▼
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1424-2013.
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