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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S. Surgical System, da Vinci Si and da Vinci Sie Surgical Systems

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 Class 2 Device Recall da Vinci S. Surgical System, da Vinci Si and da Vinci Sie Surgical Systemssee related information
Date Initiated by FirmFebruary 06, 2012
Date PostedMarch 13, 2012
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-1202-2012
Recall Event ID 61156
510(K)NumberK063220 K081137 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Productda Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Surgical, Inc. Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Code Information IS2000 and IS3000, serial numbers: 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Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information ContactRichard Reeves
408-523-2144
Manufacturer Reason
for Recall
The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions.
FDA Determined
Cause 2
Device Design
ActionIntuitive Surgical sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 3, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provided new instructions for use. Additionally, a Device Correction Response Form was enclosed for customers to complete and return via fax to 408-523-1390. Contact Intuitive Surgical Customer Service at 1-800-876-1310 for questions regarding this notice.
Quantity in Commerce1966 systems are in commerce at hospital locations.
DistributionWorldwide Distribution.
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 = NAY
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