Home / Recalls / Intuitive Surgical, Inc. / Z-2835-2018

Z-2835-2018 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
August 22, 2018
Initiation Date
May 17, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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

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.

Distribution Pattern

U.S.

Code Information

UDI Number: 00886874114193. Serial Number: SK1703.

Other recalls by Intuitive Surgical, Inc.

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  • Z-1355-2026 Class II — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Numbe (December 30, 2025)
  • Z-1096-2026 Class II — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2. (December 15, 2025)
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