—#217883

Product

Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K232610
Affected lot / code info: UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

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.

Root cause (FDA determination)

Software Design Change

Action the firm took

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: customerservice@intusurg.com.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: US distribution: LA, MA, NY, PA, TX, and VA.

Timeline

Recall initiated: 2025-11-17
Posted by FDA: 2026-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.