Z-2630-2017Class II

da Vinci Xi Surgical System

Name: Z-2630-2017 da Vinci Xi Surgical System
Creator: Intuitive Surgical, Inc.
Published: 2017-06-01
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2017-06-01 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical... on 2017-06-01. FDA classified it as Class II and gives the reason as "da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms". 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-2630-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Posted: 2017-06-06
Terminated: 2017-10-02
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Intuitive Surgical sent an Field Safety Notice letter dated June 1, 2017 to customers. The letter was sent electronically via through our da Vinci customer portal via email to the affected sites on June 1, 2017. Letters are sent to the da Vinci Coordinator, Recall Coordinator and/or Risk Management. The customer will receive a hard copy of this letter on June 6, 2017 via Fed Ex. The letter identified the affected product, problem and actions to be taken. For questions contact your Clinical Sales Representative.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan
Product codes and lots: Serial Numbers: SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, SK1190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2630-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2630-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-26

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

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)