ClearanceBrief
Recall Z-0146-2014 ยท NAY System, Surgical, Computer Controlled Instrument

Intuitive Surgical, Inc.

da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen

DateNov 4, 2013 (initiated Oct 21, 2013)
StatusTerminated
ReasonIntuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.
Root causeNonconforming Material/Component
ActionIntuitive Surgical sent an Urgent Medical Device Correction letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to open the illuminator and replace any metal-finish lamp modules with plastic finish lamp modules, if customers do not have a replacement plastic-finish lamp module available, they may continue to use the metal-finish lamp module until they receive a replacement. If the message "illuminator lamp module error: Please reseat or replace lamp module" is display
QuantityStandalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units
DistributionWorldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, India, Israel, Italy, Mexico, Monaco, Netherlands, Norway, Pakistan, Panama, Qatar, Romania, Russian
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
Intuitive Surgical, Inc., Feb 18, 2009