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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 System see related information
Date Initiated by Firm June 17, 2019
Create Date October 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-0283-2021
Recall Event ID 84963
510(K)Number K131861  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Code Information IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137  
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact
800-876-1310
Manufacturer Reason
for Recall
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
FDA Determined
Cause 2
Equipment maintenance
Action Send formal customer letter communication to the affected site. The firm reported that a representative scheduled an on-site visit to replace the affected unit.
Quantity in Commerce 1 system
Distribution US Nationwide distribution including in the state of Washington.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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