Z-1424-2013Class II

User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000

Name: Z-1424-2013 User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000
Creator: Intuitive Surgical, Inc.
Published: 2013-01-24
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2013-01-24 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided... on 2013-01-24. FDA classified it as Class II and gives the reason as "Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1424-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-24
Posted: 2013-05-29
Terminated: 2013-05-30
Recalling firm: Intuitive Surgical, Inc.
Product: User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Intuitive sent an Important Medical Device Correction letters dated January 24, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate and discard the existing TORS addendum, place the new TORS addendum included with this letter with your System User Manual, and complete and return the attached Acknowledgement Form to Intuitive Surgical. For questions call Intuitive Surgical Customer Service at 1-800-876-1310.
Quantity in commerce: 1,374
Distribution: US Distribution Only
Product codes and lots: Model number 552002-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1424-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1424-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29

Product code NAY

K090993Class IIIntuitive Surgical Endoscopic Instrument Control Systems, Models Is1200, Is2000 and Is3000Intuitive Surgical, Inc. / cleared 2009-12-16

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)