Data Foundry

Medical device recalls 2013

da Vinci Si Surgeon Console — Class II medical device recall Z-1429-2013

Terminated recall by Intuitive Surgical, Inc., reported 2013-06-05, distributed nationwide. Clarification of existing labeling information and operating procedures.

Recall numberZ-1429-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated2011-09-19
Classified2013-05-29
Reported by FDA2013-06-05
Terminated2013-05-30
DistributedNationwide (US)
Countries outside the USAR, AU, CA, CL, CN, CZ, EG, ES, IL, IN, IT, KR, PL, QA, RO, SA, SG, TH, TR, VE
Reason classeslabeling
Model numbers314850

Product

da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

Reason for recall

Clarification of existing labeling information and operating procedures.

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-1429-2013. 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.