FDA Device recall Z-1424-2013
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000 by Intuitive Surgical, citing change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1424-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-24 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | n/a |
Product
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
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Identifiers
| code_info | Model number 552002-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1424-2013%22
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