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
