Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System see related information
Date Initiated by Firm May 21, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 on May 05, 2015
Recall Number Z-1971-2014
Recall Event ID 68472
510(K)Number K021036  K050369  K081137  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.

Intuitive Surgical Endoscopic Instrument Control System.
Code Information Part number 551184 - US Manual; Part number 550965 - OUs manuals.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
408-523-2100
Manufacturer Reason
for Recall		 Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
FDA Determined
Cause 2		 Device Design
Action Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions: Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures. 2. Use Attachment C to identify the labeling that has been updated. 3. No manuals or products should be returned. Discard old versions of the User Manuals, IFUs, and QRGs for which you have received updated versions. 4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed. 5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service. 6. Retain a copy of this Notice and the Acknowledgement Form for your records. If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below: North America: 800-876-1310 Option 3 (6 am to 5pm PST) For questions regarding this recall call 408-523-2602.
Quantity in Commerce All distributed prior to June 2014
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.
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.
-
-