—#52892

Product

Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K021036, K990144
Affected lot / code info: Systems manufactured or upgraded to Model IS1200 hardware/software level in this time frame: 2/17/2000 - 3/27/2007

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

As of 9/7/2007, Intuitive Field Service Engineers have performed the upgrade via service visit on 292 of 293 U.S. systems listed on the affected sites list. A notification letter that the upgrade has been performed was left with each site after the upgrade has been completed. The firm's distributors received advance notice of the upgrades 9/13/2007.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Worldwide, including USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Romania, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.

Timeline

Recall initiated: 2007-05-03
Posted by FDA: 2007-09-26
Terminated: 2008-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.