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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S Surgical System IS2000, VisionCart Monitor Drape

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 Class 2 Device Recall da Vinci S Surgical System IS2000, VisionCart Monitor Drapesee related information
Date Initiated by FirmMarch 16, 2015
Date PostedApril 06, 2015
Recall Status1 Terminated 3 on December 03, 2015
Recall NumberZ-1384-2015
Recall Event ID 70777
510(K)NumberK050322 
Product Classification Drape, surgical - Product Code KKX
Productda Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Code Information Product number 420026-01; da Vinci S Vision-Cart Monitor Drape, 20 Pack.  Lot Numbers for Cloudy/Waxy issue: ALL lot numbers  Lot Numbers for Tear issue: None
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact
800-876-1310
Manufacturer Reason
for Recall		Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
FDA Determined
Cause 2		Packaging process control
ActionFirm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.
Quantity in Commerce442,475 total all drape models
DistributionWorldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KKX
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