Z-0275-2022Class II

The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon...

Name: Z-0275-2022 The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon...
Creator: Intuitive Surgical, Inc.
Published: 2021-09-21
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2021-09-21 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the... on 2021-09-21. FDA classified it as Class II and gives the reason as "Incorrect expiration date on its package labeling (shipper box and inner carton label)". 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-0275-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-21
Posted: 2021-11-23
Terminated: 2024-01-25
Recalling firm: Intuitive Surgical, Inc.
Product: The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Incorrect expiration date on its package labeling (shipper box and inner carton label).
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On September 21, "Urgent Medical Device Recall"-customer letter was sent out to the affected sites, via FedEx and an updated letter with legible print of labels on October 21 to non-responder customers for incorrect expiration date on the package labeling (shipper box and inner carton) label. Both shipper and carton label had expiration date as 11/30/2023 instead of 01/31/2023. The Affected product is being requested to be returned per attached field safety notice (5556010-01 Rev A). The customers had been requested to fax or E-mail the acknowledgement form to, Attn: REGULATORY COMPLIANCE FIELD ACTIONS; Subject line for email: ISIFA2021-05-R Xi Drape Expiration Date U.S. Fax +1(408) 523-0619, or Scan and Email: [email protected]. The firm expects customers to call or email the firm with the unused quantities to receive the replacement or credit to return the affected devices, if customers call or send an E-mail. The firm will provide RMA when customers call the firm. Customers are advised to take actions as: Inform necessary hospital personnel about this issue. 2. Locate all affected products at their site and return to the firm via the standard RMA process. 3. Inform affected personnel when the requested actions have been completed. 4. Complete the attached Acknowledgement Form immediately and return to the firm via fax or email as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for customer's files. Replacements will be provided against returned affected product. Customers are provided contact information as: Customers Clinical Sales Representative or contact at the numbers listed below: " North America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)
Quantity in commerce: 1,740 drapes (87 bobes)
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.
Product codes and lots: Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0275-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0275-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)