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U.S. Department of Health and Human Services

Class 2 Device Recall daVinci S Surgical System IS2000

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 Class 2 Recall
daVinci S Surgical System IS2000
see related information
Date Posted February 21, 2008
Recall Status1 Terminated on September 05, 2008
Recall Number Z-0079-2008
Recall Event ID 38311
Premarket Notification
510(K) Numbers
K050369  K060322 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.
Code Information Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1. System Numbers: all starting with "SG"-- 043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170, 098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068, 069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129, 087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169, 041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093, 094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154, 018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012, 015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062, 143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159, 076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and 126
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
Manufacturer Reason
for Recall
System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.
FDA Determined
Cause 2
DESIGN: Software Design
Action Intuitive Field Service Engineers installed a software upgrade beginning on 03/30/2007, and left a notification letter that the upgrade had been performed at each site. New software level is A5.1 P2.
Quantity in Commerce 159
Distribution Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.
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 = CLINIQA CORPORATION
510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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