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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Xi" Surgical System

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 Class 2 Device Recall da Vinci Xi" Surgical Systemsee related information
Date Initiated by FirmOctober 05, 2016
Date PostedOctober 26, 2016
Recall Status1 Terminated 3 on May 01, 2017
Recall NumberZ-0315-2017
Recall Event ID 75473
510(K)NumberK131861 
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Productda Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Code Information All systems manufactured with or upgraded to P5 software.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information ContactMark Johnson
408-523-2100
Manufacturer Reason
for Recall		Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
FDA Determined
Cause 2		Software design
ActionUrgent Medical Device Correction letters were sent on October 12, 2016 by traceable method to all affected customers. Letters notify customers of the issue and provided instructions to prevent it from happening until ISI software can install new software upgrade in 1st Q 2017.
Quantity in Commerce677 devices
DistributionAustralia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
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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