daVinci Xi recallZ-1262-2023 · Intuitive Surgical, Inc. · initiated Jan 24, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Component change control
What the company is doing
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]
Recall details
- Recall number
- Z-1262-2023
- Status
- Open, Classified
- Initiated by the company
- Jan 24, 2023
- Posted by the FDA
- Mar 16, 2023
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 9
- Product code
- NAY
- FDA submissions
- K131861, K171294
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- daVinci Xi 380652Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls235 deaths5,316 reports
- daVinci X 380620Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls41 deaths684 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page