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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 Device Recall daVinci Surgical System Model IS1200, A4.3 SW levelsee related information
Date Initiated by FirmMay 03, 2007
Date PostedSeptember 26, 2007
Recall Status1 Terminated 3 on July 02, 2008
Recall NumberZ-1244-2007
Recall Event ID 38069
510(K)NumberK021036 K990144 
Product Classification Endoscopic Instrument Control System - Product Code NAY
ProductEndoscopic 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 CA 94086-5304
For Additional Information Contact
408-523-2100
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		Software design
ActionAs 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 Commerce405
DistributionWorldwide, 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NAY
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