Use cautionMedical device recall · FDA · Published June 17, 2019
Intuitive Surgical da Vinci Xi Endoscope Controller Recall: Risk of Thermal Tissue Injury
Intuitive Surgical recalls da Vinci Xi Endoscope Controller Model 372601-16 due to improper calibration causing potential thermal tissue injury and overly bright images during surgery.
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Intuitive Surgical is recalling a specific endoscope controller used in their da Vinci surgical system because it was improperly calibrated during servicing. This could cause the endoscope tip to overheat, potentially injuring tissue or creating overly bright images during surgery. Read more at govinfonow.com/recall/67660-intuitive-surgical-da-vinci-xi-endoscope-controller-recall-risk-of.
“Intuitive Surgical da Vinci Xi Endoscope Controller Recall: Risk of Thermal Tissue Injury.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67660-intuitive-surgical-da-vinci-xi-endoscope-controller-recall-risk-of. Based on FDA recall #Z-0283-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0283-2021%22&limit=1).
Intuitive Surgical, Inc. recalled one da Vinci Surgical System IS 4000 with an improperly calibrated Endoscope Controller (Model No. 372601-16) on June 17, 2019, according to the FDA. The hazard is potential thermal tissue injury and overly bright images due to higher temperatures at the endoscope tip.
How to tell if you have it
Brand: Intuitive Surgical
Product: da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193)
Included in: IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898)
Serial Numbers: IS4000 Endoscope Controller Serial Number: 432242; da Vinci Surgical System Serial Number: SK2137
Quantity: 1 system
Distribution: US Nationwide, including Washington
The hazard
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since 2017-06-01. Other recent recalls of similar products include Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (2026-04-24), Intuitive Surgical Da Vinci Surgical System Recall (2026-04-22), and Da Vinci X and Xi Surgical Systems Recall (2026-04-02). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03), Olympus Single Use Sphincterotome V Recall (2026-01-07), and Olympus Disposable Triple Lumen Sphincterotome Recall (2026-01-07).
How to tell if you have this one
Check for the model number 372601-16 on the endoscope controller. The product is included in the IS 4000 Vision Cart with model number 381121-31.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Status
Verify if the endoscope controller has been properly calibrated by contacting Intuitive Surgical directly.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution including in the state of Washington.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0283-2021 (June 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0283-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.