Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086

FDA Recall Z-1180-2008 · Posted 2008-06-12

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2007-12-27
Date Terminated2008-08-15
Product Quantity9 units

Reason for Recall

Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.

Firm Action

Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.

Root Cause

Software design

Distribution Pattern

USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000Intuitive Surgical, Inc. · 2005-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑