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Incident · Recall

Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use

Intuitive recalled software for da Vinci X/Xi and da Vinci 5 systems because a defect could leave arms that had failed self-diagnostics still available for clinical use. Source: FDA device recall Z-1232-2026, accessdata.fda.gov / openFDA enforcement.

Occurred 2025-11-07 · Intuitive Surgical · Investigated by FDA

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Track Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use

Machine-readable surfaces

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=219087

Common questions

What happened in Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use?
Intuitive recalled software for da Vinci X/Xi and da Vinci 5 systems because a defect could leave arms that had failed self-diagnostics still available for clinical use. Source: FDA device recall Z-1232-2026, accessdata.fda.gov / openFDA enforcement.
When did this incident occur?
The incident is recorded as occurring on November 7, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use?
The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use.

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Canonical ID 79f21a51-367b-4dab-b209-213078f6a391