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

FDA device recall Z-1428-2026 · posted 2026-02-18 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Software Design Change

Status

Open, Classified

Product code

NAY

Quantity affected

12

Distribution

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

Date initiated

2025-11-17

Date posted

2026-02-18

Location

Sunnyvale, CA

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