User Manual addendum — Class II medical device recall Z-1424-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-06-05. Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
| Recall number | Z-1424-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-01-24 |
| Classified | 2013-05-29 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2013-05-30 |
| Quantity | 1,374 |
| Model numbers | 552002-01 |
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 for recall
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1424-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.