Z-2835-2018Class II

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

Name: Z-2835-2018 The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16
Creator: Intuitive Surgical, Inc.
Published: 2018-05-17
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2018-05-17 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16 on 2018-05-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2835-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-05-17
Posted: 2018-08-16
Recalling firm: Intuitive Surgical, Inc.
Product: The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Use error
Action: Intuitive Surgical notified customers via a "Field Safety Notice Urgent Medical Device Correction ISIFA2018-06-C da Vinci Xi Miscalibrated Endoscope Controller" letter. The letter provided: Reason for Field Action, Risk to Health, Affected Products (description, part number, serial number), Action taken by Intuitive Surgical, Actions to be taken by the Customer/ User, contact information for Further Information & Support, and an Acknowledgement Form.
Quantity in commerce: 1
Distribution: U.S.
Product codes and lots: UDI Number: 00886874114193. Serial Number: SK1703.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2835-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2835-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-22	2018-08-16

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)