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U.S. Department of Health and Human Services

Class 2 Device Recall The da Vinci Xi Surgical System (IS4000)

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 Class 2 Device Recall The da Vinci Xi Surgical System (IS4000)see related information
Date Initiated by FirmMay 17, 2018
Create DateAugust 16, 2018
Recall Status1 Open3, Classified
Recall NumberZ-2835-2018
Recall Event ID 80691
510(K)NumberK131861 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
ProductThe da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Code Information UDI Number: 00886874114193. Serial Number: SK1703.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
FDA Determined
Cause 2		Use error
ActionIntuitive Surgical notified customers via a "Field Safety Notice Urgent Medical Device Correction  ISIFA2018-06-C da Vinci Xi Miscalibrated Endoscope Controller" letter. The letter provided: Reason for Field Action, Risk to Health, Affected Products (description, part number, serial number), Action taken by Intuitive Surgical, Actions to be taken by the Customer/ User, contact information for Further Information & Support, and an Acknowledgement Form.
Quantity in Commerce1
DistributionU.S.
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 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) Database510(K)s with Product Code = NAY
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