ClearanceBrief
Recall Z-0079-2008 ยท NAY System, Surgical, Computer Controlled Instrument

Intuitive Surgical, Inc.

Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.

DateFeb 21, 2008 (initiated Mar 30, 2007)
StatusTerminated
ReasonSystem Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.
Root causeSoftware design
ActionIntuitive Field Service Engineers installed a software upgrade beginning on 03/30/2007, and left a notification letter that the upgrade had been performed at each site. New software level is A5.1 P2.
Quantity159
DistributionWorldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
Intuitive Surgical, Inc., Apr 29, 2005
K060322CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
Cliniqa Corporation, Mar 21, 2006