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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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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 Number Z-1244-2007
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
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.
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.
 
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