FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display

[in effect]

United States · operational restriction · operational restriction

Jurisdiction

United States

Classification

operational restriction

Status

in effect

Effective Date

Feb 12, 2026

Primary Sources

1 audited

Statutory Scope & Summary

FDA Class 2 recall of the da Vinci 5 Surgeon Console Viewer Display (Part Number 380730-45) due to display issues affecting surgical visualization. One of multiple 2026 recalls of da Vinci 5 system components.

Covered Sectors & Application Domains

Regulatory Analysis & Inquiries

6 entries
What does FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display cover?

FDA Class 2 recall of the da Vinci 5 Surgeon Console Viewer Display (Part Number 380730-45) due to display issues affecting surgical visualization. One of multiple 2026 recalls of da Vinci 5 system components.

Where does FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display apply?

FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display is recorded as a operational_restriction applying in United States on the DEPLOY registry.

When did FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display take effect?

FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display is recorded as effective February 12, 2026 on the DEPLOY registry.

Is FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display still in effect?

FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display is currently in effect and applies to covered operators in the named jurisdiction.

What types of robots does FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display apply to?

FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display is recorded as applying to surgical on the DEPLOY registry.

Which robot models on the DEPLOY registry fall under FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display?

8 robot models on the DEPLOY registry match the form-factor scope of FDA Class 2 Recall: Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.

Primary Sources & Legal Instruments

1 document
  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217888

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217888

    Official Source