HIGH

Intuitive Surgical Recalls Da Vinci 5 Console Over Software Error

Intuitive Surgical recalled 12 Da Vinci 5 surgical consoles on November 17, 2025. A software error may cause loss of user interface content on external monitors. Healthcare providers must stop using the devices immediately.

Quick Facts at a Glance

Recall Date
November 17, 2025
Hazard Level
HIGH
Brand
Intuitive Surgical
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
6 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Da Vinci 5 Console is part of a robotic surgical system designed for minimally invasive procedures. Its advanced technology allows surgeons to perform complex surgeries with precision and control.

Why This Is Dangerous

The software error can disrupt the visual interface used by surgeons, making it difficult to monitor and control surgical procedures effectively. This can lead to operational failures during critical moments.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall poses significant safety concerns for ongoing surgeries and could lead to operational downtime for healthcare facilities.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on your Da Vinci 5 Console to see if it matches the recalled model 380730.
  2. Verify the software version; the issue arises from version P1.2.1.
  3. Consult with your healthcare provider for confirmation.

Where to find product info

The model number can typically be found on the back or bottom of the console, along with the software version in the device settings.

What timeline to expect

Expect a timeline of 4-6 weeks for processing refunds or replacements once the manufacturer has been contacted.

If the manufacturer is unresponsive

  • Document all communication attempts with the manufacturer.
  • Reach out to your healthcare provider for assistance.
  • Consider filing a complaint with the FDA if no response is received.

How to prevent similar issues

  • Ensure medical devices have up-to-date software before use.
  • Regularly check for any recalls or safety notifications from manufacturers.
  • Consult with peers about industry best practices for equipment safety.

Documentation advice

Keep records of all communications with the manufacturer, including emails and letters, as well as any relevant receipts or purchase confirmations.

Product Details

The recalled product is the Da Vinci 5 Console, model number 380730. It was sold in Louisiana, Massachusetts, New York, Pennsylvania, Texas, and Virginia. The console is used for minimally invasive surgery.

Key Facts

  • Recall date: November 17, 2025
  • Quantity recalled: 12 units
  • Distribution states: LA, MA, NY, PA, TX, VA
  • Hazard classification: Class II
  • Manufacturer: Intuitive Surgical, Inc.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Affected States
LA, MA, NY, PA, TX, VA
Report Date
February 25, 2026
Recall Status
ACTIVE

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