Lower riskMedical device recall · FDA · Published May 17, 2018
Intuitive Surgical da Vinci Xi Endoscope Controller Recall: Dim/Color Issues
Intuitive Surgical recalls da Vinci Xi Endoscope Controller (model IS4000) due to dim, color-imbalanced surgical images and potential fogging. Affected units have specific model and serial numbers.
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.
“Intuitive Surgical da Vinci Xi Endoscope Controller Recall: Dim/Color Issues.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71037-intuitive-surgical-da-vinci-xi-endoscope-controller-recall-dim-color. Based on FDA recall #Z-2835-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2835-2018%22&limit=1).
The Food and Drug Administration announced on May 17, 2018, that Intuitive Surgical, Inc. is recalling the da Vinci Xi Surgical System (IS4000) Endoscope Controller due to improper calibration. This defect may result in dimmer surgical images, color imbalance, reduced fluorescence, or increased fogging.
How to tell if you have it
Brand: Intuitive Surgical
Product: The da Vinci Xi Surgical System (IS4000), Endoscope Controller
Model Name: IS4000
Model Number: 372601-16
UDI Number: 00886874114193
Serial Number: SK1703
The hazard
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.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls include a Da Vinci 5 dV5 Tower NIR Handheld Camera recall on April 24, 2026, and an Intuitive Surgical Da Vinci Surgical System recall on April 22, 2026. Similar recent recalls of similar products include a Vortex Surgical TID Pharos Illuminated Depressor recall on Dec. 16, 2025, and an Olympus Disposable Triple Lumen Sphincterotome recall on Jan. 7, 2026.
How to tell if you have this one
Check for the model name 'IS4000' and serial number 'SK1703' on the device. The product was sold with model number 372601-16 and UDI number 00886874114193.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for the model name 'IS4000' and serial number 'SK1703' on the device.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2835-2018 (May 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2835-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.