Z-0088-2014Class II

da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution...

Name: Z-0088-2014 da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution...
Creator: Intuitive Surgical, Inc.
Published: 2011-10-17
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2011-10-17 / Terminated

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate... on 2011-10-17. FDA classified it as Class II and gives the reason as "Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0088-2014
Classification: Class II
Status: Terminated
Initiated: 2011-10-17
Posted: 2013-10-28
Terminated: 2013-10-28
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
FDA root cause: Use error
Action: Advisory letters were sent to all affected customers on 10/17/11 informing them to contact Customer Service prior to moving the system outside of the hospital.
Quantity in commerce: 1,090 consoles
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Product codes and lots: model numbers 380610-04 through 38-610-14.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0088-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0088-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28

Product code NAY

K081137Class IIIntuitive Surgical Da Vinci Si Surgical System: Model Is3000Intuitive Surgical, Inc. / cleared 2009-02-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)