Z-1961-2020Class II

da Vinci X Surgical System

Name: Z-1961-2020 da Vinci X Surgical System
Creator: Intuitive Surgical, Inc.
Published: 2018-11-21
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2018-11-21 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci X Surgical System on 2018-11-21. FDA classified it as Class II and gives the reason as "Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery". 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-1961-2020
Classification: Class II
Status: Terminated
Initiated: 2018-11-21
Posted: 2020-05-11
Terminated: 2022-05-31
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci X Surgical System
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/21/2018, the firm sent an "Urgent Medical Device Correction" Notification to its customers informing them that the firm had become aware of specific surgical systems were shipped with a manufacturing variation in the arm, which may result in a persistent recoverable fault (error 23087) with could occur prior or during a surgical procedure. The firm emphasized that as indicated in the User Manual, if this fault is persistent, ten the affected arm may be disabled. The firm is instructing that: 1. Inform surgeons and patient side assistants using the surgical system to read and understand the contents of this letter. 2. Additionally, forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who perform procedures. 3. Place a copy of this letter with their User Manual until the corrective action has been completed. 4. Inform affected personnel when corrective action has been completed. 5. Please log into the Recalling Firm's Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 6. In the case where the online resource cannot be used, complete the attached Acknowledgement Form and return it via fax. 7. Please retain a copy of the letter and the acknowledgement form for their files. Actions being taken by the Recalling Firm are: 1. To correct the issue described in this Field Safety Notice, an Recalling Firm representative will schedule a site visit to replace the affected arm. 2. A copy of the Field Safety Notice will be provided to customers with affected surgical systems. 3. A Recalling Firm's representatives will be available by phone to answer any questions related to this Field Safety Notice. Contact Information for any questions: If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Repres
Quantity in commerce: 74 USMs containing affected rotors
Distribution: U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.
Product codes and lots: Model: IS4200 UDI: 00886874114216 Device Listing: D295931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1961-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1960-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11
Z-1961-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11

Product code NAY

K171294Class IIda Vinci X Surgical SystemIntuitive Surgical, Inc. / cleared 2017-05-26

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)