FDA-Device2018-08-22Class II
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Intuitive Surgical, Inc.
Hazard
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.
Sold states
U.S.
Affected count
1
Manufactured in
1266 Kifer Rd Bldg 101, Sunnyvale, CA, United States
Products
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2835-2018Don't want to check this manually?
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