The da Vinci Xi Surgical System : IS4000 recalled over fire hazard

Recall date

May 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-2835-2018

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

U.S.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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