Recall Z-1428-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
| Date | Feb 18, 2026 (initiated Nov 17, 2025) |
| Status | Open, Classified |
| Reason | 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 | Software Design Change |
| Action | 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 |
| Quantity | 12 |
| Distribution | US distribution: LA, MA, NY, PA, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation Intuitive Surgical, Inc., Mar 14, 2024 |