Company: Intuitive Surgical, Inc.,
Date of Enforcement Report 9/24/2008
Class:ll
PRODUCT
da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, Recall # Z-2204-2008
REASON
Defective software chip may cause the system to fail and lock up.
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letters, telephone and service visits beginning June 1, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
112 systems
DISTRIBUTION
Nationwide and Internationally
