Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086
FDA Recall Z-1244-2007 · Posted 2007-09-26
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2007-05-03
Date Terminated2008-07-02
Product Quantity405
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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