Z-1426-2013Class II

Thyroidectomy Indication for the da Vinci Surgical Systems

Name: Z-1426-2013 Thyroidectomy Indication for the da Vinci Surgical Systems
Creator: Intuitive Surgical, Inc.
Published: 2011-10-13
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2011-10-13 / Terminated

FDA source

Intuitive Surgical, Inc. began a recall of Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and... on 2011-10-13. FDA classified it as Class II and gives the reason as "Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1426-2013
Classification: Class II
Status: Terminated
Initiated: 2011-10-13
Posted: 2013-05-29
Terminated: 2013-05-30
Recalling firm: Intuitive Surgical, Inc.
Product: Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
FDA root cause: No Marketing Application
Action: Intuitive sent a notification letter on October 17, 2011 by email to all consigness whose email address were on file. Also a copy of the letter was sent by registered mail on February 8, 2012 to all surgeons whose addresses were on file. The letters informed consignees that Intuitive Surgical were in the process of reviewing labeling for the da Vinci System in regard to use for thyroidectomy procedures. During this period, Intuitive will not provide or facilitate any promotional, training, case observations, proctoring or in case procedural support for use of the da Vinci System in conjunction with thyroidectomy procedures. The letters recommend consulting the institution policy regarding use of approved or cleared medical devices for procedures that are not specified in the labeled indication for use. Questions may be directed to customer service at 1-877-408-3872.
Quantity in commerce: 2,423 consignee
Distribution: USA Nationwide distribution
Product codes and lots: NA - marketing and promotional only.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1426-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1426-2013	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)