Intuitive Surgical Recalls Da Vinci 5 Surgical Consoles Due to Software Error

What Happened

Intuitive Surgical, Inc. has initiated a voluntary recall of certain Da Vinci 5 surgical consoles following the discovery of a software error. The issue, associated with software version P1.2.1, can result in the loss of user interface content on external monitors or tower monitors during surgical procedures.

Which Products Are Affected

The recall involves 12 units of the following product:

• Product Name: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000
• Model/Catalog Number: 380730
• Software Version: P1.2.1
• GTIN: 0886874119747
• UDI-DI: 00886874119747
• Recall Number: Z-1428-2026

These units were distributed to medical facilities in the following states: Louisiana, Massachusetts, New York, Pennsylvania, Texas, and Virginia.

What You Should Do

Intuitive Surgical, Inc. notified affected customers via a formal letter initiated on November 17, 2025. Healthcare providers and facilities using the Da Vinci 5 system should verify if their equipment is running software version P1.2.1. Affected users should follow the specific guidance provided in the firm’s notification letter regarding necessary software corrections or system updates.

Why This Matters

The Da Vinci 5 system is utilized for minimally invasive surgeries. A loss of user interface content on external or tower monitors can disrupt the surgical environment and impact the visibility of critical system information for the surgical team. The FDA has classified this as a Class II recall.

Source

This information is based on an official report from the FDA.