Z-2835-2018 Class II Ongoing
FDA device recall Z-2835-2018 was initiated by Intuitive Surgical, Inc. on May 17, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2018
- Initiation Date
- May 17, 2018
- 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2835-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026