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.
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.
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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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.
The software issue can lead to a loss of user interface content on external monitors or tower monitors. This malfunction may hinder the surgeon's ability to operate, posing serious risks during surgical procedures.
No specific incidents of injury or death have been reported. However, the potential for operational failure raises significant safety concerns.
Stop using the Da Vinci 5 Console immediately. Contact Intuitive Surgical, Inc. or your healthcare provider for further instructions regarding the recall.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1428-2026.
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