Recall Z-2835-2018— Intuitive Surgical, Inc.

Name: FDA recall Z-2835-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-17

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2018-05-17. It names one FDA 510(k) clearance: K131861. Product: The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.. Reason: 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..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2018-05-17
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.