Z-1967-2014Class II

Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive...

Name: Z-1967-2014 Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive...
Creator: Intuitive Surgical, Inc.
Published: 2014-05-21
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-05-21 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System on 2014-05-21. FDA classified it as Class II and gives the reason as "Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1967-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-21
Posted: 2014-07-02
Terminated: 2015-05-05
Recalling firm: Intuitive Surgical, Inc.
Product: Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions: Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures. 2. Use Attachment C to identify the labeling that has been updated. 3. No manuals or products should be returned. Discard old versions of the User Manuals, IFUs, and QRGs for which you have received updated versions. 4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed. 5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service. 6. Retain a copy of this Notice and the Acknowledgement Form for your records. If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below: North America: 800-876-1310 Option 3 (6 am to 5pm PST) For questions regarding this recall call 408-523-2602.
Quantity in commerce: All distributed prior to June 2014
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.
Product codes and lots: Part number 550973

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1967-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1964-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1965-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1966-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1967-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1968-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1969-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1970-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1971-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1972-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1973-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1974-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01
Z-1975-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

Product code NAY

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)