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U.S. Department of Health and Human Services

Class 2 Device Recall daVinci Surgical System Model IS1200, A4.3 SW level

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 Class 2 Recall
daVinci Surgical System Model IS1200, A4.3 SW level
see related information
Date Posted September 26, 2007
Recall Status1 Terminated on July 02, 2008
Recall Number Z-1244-2007
Recall Event ID 38069
Premarket Notification
510(K) Numbers
K021036  K990144 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086
Code Information Systems manufactured or upgraded to Model IS1200 hardware/software level in this time frame: 2/17/2000 - 3/27/2007
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale, California 94086-5304
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 405
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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