FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: 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
- Recall number
- Z-1262-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-01-24
- Posted
- 2023-03-16
- Terminated
- not on file
- Reason
- 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.
- 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 Recalls@intusurg.com 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: customerservice@intusurg.com. - Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com Taiwan: 886-2-2-27008181 (9am to 6:00pm CST) or CS.taiwan@intusurg.com
- Quantity
- 9
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K131861","K171294"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28