Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000 Recalled by Intuitive Surgical, Inc. Due to An Endoscope Controller has been improperly calibrated during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical, Inc. directly.
Affected Products
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Quantity: 1
Why Was This Recalled?
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.
Where Was This Sold?
U.S.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report