medical Class II Updated 2018-08-22

Intuitive Surgical, Inc. recalls The da Vinci Xi Surgical System (IS4000) Model Name: IS4000,

Recalled Product

The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.


Hazard / Issue

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.

Issued by

FDA

Distribution: U.S.
Lot/Code Info: UDI Number: 00886874114193. Serial Number: SK1703.
View official government recall

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