da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA.
FDA Recall Z-2204-2008 · Posted 2008-09-16
Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2008-06-01
Date Terminated2009-07-29
Product Quantity112 systems
Reason for Recall
Defective software chip may cause the system to fail and lock up.
Firm Action
Recall initiated June 1, 2008. Urgent Device Recall Letters were sent via e-mail, with follow up phone calls and service visits to correct the product. The firm recommended that continued use of the da Vinci S Surgical System during the time period prior to our service update to replace the software chip. The letter emphasizes the importance of always having backup equipment and instrumentation available when performing surgery with the da Vinci S Surgical System and being prepared to convert to alternative surgical techniques, if necessary. Customers are asked to fill out and return the acknowledgement form.
Root Cause
Software design (manufacturing process)
Distribution Pattern
Worldwide Distribution --- including USA and countries of Belgium, Bulgaria, Canada, China, Denmark, France, Germany, Italy, Korea, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.