Z-1262-2023Class II

Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF...

Name: Z-1262-2023 Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF...
Creator: Intuitive Surgical, Inc.
Published: 2023-01-24
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2023-01-24 / Open, Classified

FDA source

Intuitive Surgical, Inc. began a recall of Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with... on 2023-01-24. FDA classified it as Class II and gives the reason as "Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1262-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-24
Posted: 2023-03-16
Recalling firm: Intuitive Surgical, Inc.
Product: Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
FDA root cause: Component change control
Action: On 01/24/2023, New Field Safety Notices were sent to customers. In addition, some customers received another notice informing them that additional preventative maintenance data would need to be collected by the recalling firm's field service personnel, to determine if additional devices were affected. On 1/27/2023, updated New Field Safety Notices were sent to two additional customers. Customers were asked to do the following: 1) Review this Field Safety Notification with all system users and place a copy of it with Instructions for use (IFU) of the system. 2) Complete and return the Acknowledgment Form via email to [email protected] The recalling firm will replace instrument arms found to be affected and will update the Preventive Maintenance Test to include the same analysis/method of processing Insertion Axis Friction Data that was used for determining the affected product for this Field Safety Notice so any new USM that may become susceptible will get addressed as part of the same. Customers with questions can contact customer service at: - US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. - Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or [email protected] - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or [email protected] Taiwan: 886-2-2-27008181 (9am to 6:00pm CST) or [email protected]
Quantity in commerce: 9
Distribution: Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France
Product codes and lots: System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1262-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1262-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-16

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