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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 September 26, 2007
Recall Status1 Terminated on December 03, 2007
Recall Number Z-1245-2007
Recall Event ID 38301
Premarket Notification
510(K) Numbers
K050369  K063220 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
Code Information Model number IS2000, part number 351040-04. System numbers SG002, SG004, SG010 , SG032, SG060, SG061, SG064, SG065, SG066, SG067, SG068, SG069, SG070, SG071, SG072, SG073, SG074, SG075, SG076, SG077, SG078, SG079, SG080, SG081, SG082, SG083, SG084, SG086, SG090, SG116, SG117, SG118, SG120, SG121, SG126, SG174, SG175, SG184
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Product may malfunction and fail to start up on AC power.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action As of 9/12/2007, the firm has conducted a field inspection of any involved units via service visit. No other notice is planned or indicated by the firm's submission. The firm feels that the risk associated with this issue is minimal, and therefore, any advanced notification is unneccessary. If any system failed one or more of the inspection points, its APB (3510404-04) was replaced with a verified APB (351040-04 or 351040-05).
Quantity in Commerce 38 units
Distribution Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.
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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