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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Da Vinci S Surgical System		see related information
Date Posted March 29, 2007
Recall Number Z-0670-2007
Product Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Code Information System Numbers: SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
Action The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.
Quantity in Commerce 24 units
Distribution Nationwide.
 
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