04
Oct
2007

Inc., Cl II Intuitive Surgical

0

Company:Intuitive Surgical, Inc.,
Date of Enforcement Report:10/3/2007
Class:ll

PRODUCT
Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Recall # Z-1244-2007

REASON
Under certain circumstances, the product’s software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clarify an icon not described in the previous User Manual.

RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by visit beginning on September 7, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
405 units

DISTRIBUTION
Nationwide and Internationally

About the author

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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