Z-1686-2013Class II

da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086...

Name: Z-1686-2013 da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086...
Creator: Intuitive Surgical, Inc.
Published: 2013-06-08
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2013-06-08 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control... on 2013-06-08. FDA classified it as Class II and gives the reason as "Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1686-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-08
Posted: 2013-07-11
Terminated: 2014-01-22
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Root cause tag: software
FDA root cause: Software design
Action: Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3. For questions regarding this recall call 408-523-2244.
Quantity in commerce: 30 total, all devices
Distribution: Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
Product codes and lots: Part number 380610-15: Serial numbers: 323936 323937 325082 325143 325175 325178 325355 325290 325352 325669 325672 325692 325444 325446 325447 325583 325585 325587 325634 325671 325684 325720 325724 325719 325888 325465 325549 325266 325268 323875 324092 324098 324100 324190 324258 324260 324265 324370 324425 324426 324528 324585 324586 324638 324649 324847 324848 324849 325076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1686-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1686-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1687-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1688-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1689-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11

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