Z-1110-2013Class II

IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System...

Name: Z-1110-2013 IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System...
Creator: Intuitive Surgical, Inc.
Published: 2013-03-15
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2013-03-15 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from... on 2013-03-15. FDA classified it as Class II and gives the reason as "Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1110-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-15
Posted: 2013-04-13
Terminated: 2014-09-04
Recalling firm: Intuitive Surgical, Inc.
Product: IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated April 1, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-876-1310 for questions regarding this letter.
Quantity in commerce: 1642 customers
Distribution: Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Model number 550650-05 (P8)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1110-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-13
Z-1110-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-13

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)