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Incident · Recall

Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display

FDA Class 2 recall Z-1428-2026 (firm-initiated Nov 17 2025; posted Feb 18 2026): Software version P1.2.1 caused an increase in Error 48306 events on da Vinci 5 systems in dual console configuration, causing User Interface application crashes and loss of interaction at the affected node. External monitor and tower monitor UI may not display (live endoscopic video still displayed).

FDA-determined cause: Software Design Change. 12 units in commerce across 6 US states. Corrective patch P1.2.2 in development.

Occurred 2025-11-17 · da Vinci (and Ion) at Hong Kong, China · Intuitive Surgical · Hong Kong, China · Surgical robots · Investigated by FDA

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Track Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display

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Sources (1)

  1. FDA (Class 2 Recall Z-1428-2026) · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217883

Common questions

What happened in Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
FDA Class 2 recall Z-1428-2026 (firm-initiated Nov 17 2025; posted Feb 18 2026): Software version P1.2.1 caused an increase in Error 48306 events on da Vinci 5 systems in dual console configuration, causing User Interface application crashes and loss of interaction at the affected node. External monitor and tower monitor UI may not display (live endoscopic video still displayed). FDA-determined cause: Software Design Change. 12 units in commerce across 6 US states. Corrective patch P1.2.2 in development.
When did this incident occur?
The incident is recorded as occurring on November 17, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at Hong Kong, China.
Has anyone responded to Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
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 Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display?
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 Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display.

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