Feb

2008

Intuitive Surgical Da Vinci Surgical System Cl II

Company: Intuitive Surgical, Inc.,
Date of Enforcement Report 2/27/2008
Class:ll

PRODUCT
Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1, Recall # Z-0079-2008

REASON
System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe “soft-lock” state.

RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter and software upgrade beginning on March 30, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
154 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Intuitive Surgical Da Vinci Surgical System Cl II

Amy Sellers

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