FDA recall Z-2835-2018

Product

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

U.S.

Key facts

Status

Ongoing

Initiation date

2018-05-17

Report date

2018-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2835-2018