daVinci 5 recallZ-1428-2026 · Intuitive Surgical, Inc. · initiated Nov 17, 2025
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
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
FDA root cause category: Software Design Change
What the company is doing
On 11/17/2025, the firm emailed a "New Customer Communication" to customers informing them that Intuitive has become aware, following the distribution of P1.2.1 software version for dV5 Systems between October 17, 2025 and October 24, 2025, of an increase in 48306 error events observed on Da Vinci 5 Surgical Systems in dual console configuration, causing User Interface (UI) application crashes and loss of interaction at the affected node. Customers are instructed to: Continue Safe Use: If error 48306 occurs, follow the on-screen instructions and select Retry to recover. Affected systems may continue to be used following the recovery of error 48306 with the awareness of potential loss of non-essential UI features as outlined below: " User interface may not be displayed on connected external monitor live endoscopic video is still displayed " User interface may not be displayed on the dV5 Tower monitor - live endoscopic video is still displayed " System may be unable to activate Tile/Overlay layout user is unable to stream video input from external sources into the Console viewer. If UI streaming remains unavailable, restart the system during the procedure to restore full functionality. Guidance is available in Appendix B, Faults that Require Restarting , of Da Vinci 5 User Manual PN 555500-05. Intuitive Surgical is developing a corrective software patch (version P1.2.2). When ready, customers will be contacted to schedule installation. Please take the additional following actions: 1. Display this communication with systems; ensure it is in a place likely to be seen/viewed by operators. 2. Retain a copy of this letter and the acknowledgement form for your files. For questions - contact Intuitive Representative or contact Intuitive Customer Service at: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected].
Recall details
- Recall number
- Z-1428-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 17, 2025
- Posted by the FDA
- Feb 18, 2026
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 12
- Product code
- NAY
- FDA submissions
- K232610
- Distribution
- US distribution: LA, MA, NY, PA, TX, and VA.
Product description
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Code information (models, lots, serial numbers)
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- daVinci 5 380730Intuitive Surgical, Inc. · System, surgical, computer controlled instrument4 recalls579 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.
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