Z-1871-2014Class II

IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc

Name: Z-1871-2014 IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc
Creator: Intuitive Surgical, Inc.
Published: 2014-06-11
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-06-11 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc on 2014-06-11. FDA classified it as Class II and gives the reason as "In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1871-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Posted: 2014-06-25
Terminated: 2014-07-02
Recalling firm: Intuitive Surgical, Inc.
Product: IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue
Root cause tag: design
FDA root cause: Device Design
Action: Medical Device Recall notifications were sent to the 4 affected sites on June 11, 2014. Letters describe the problem and the potential health risk. The two model numbers of the endoscope are listed and the statement that ISI will perform a software upgrade to the da Vinci System and replace the endoscopes. Letters request that the following actions take place: - Ensure that all appropriate personnel are fully informed of the information provided in the notification letter. - Complete and return the acknowledgement form using instructions provided. - Retain a copy of The letter for your records. Intuitive representatives will schedule a site visit to provide the re-calibrated endoscope, update the software and ensure that it is properly integrated with the da Vinci Xi Surgical System. Questions or concerns may be directed to Intuitive Customer Service at 800-876-1310.
Quantity in commerce: 19 units
Distribution: Distributed in the states of FL, TX, and NY.
Product codes and lots: 470026-18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1871-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1870-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1871-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25

Product code NAY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)