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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 Device Recall daVinci S Surgical System IS2000 see related information
Date Initiated by Firm May 14, 2007
Date Posted September 26, 2007
Recall Status1 Terminated 3 on December 03, 2007
Recall Number Z-1245-2007
Recall Event ID 38301
510(K)Number K050369  K063220  
Product Classification endoscopic instrument control system - 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 CA 94086-5206
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		 Product may malfunction and fail to start up on AC power.
FDA Determined
Cause 2		 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 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) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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