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FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field

FDA classified Class 2 recall for da Vinci 5 (IS5000). Viewer Display manufactured with outdated firmware may result in loss of one display and loss of 3D surgical field depth perception. Recall Z-1428-2026.

Occurred 2026-02-18 · Intuitive Surgical

Track FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217883

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
FDA classified Class 2 recall for da Vinci 5 (IS5000). Viewer Display manufactured with outdated firmware may result in loss of one display and loss of 3D surgical field depth perception. Recall Z-1428-2026.
When did this incident occur?
The incident is recorded as occurring on February 18, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
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 FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
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 FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-07-03

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-07-03

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 FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field.

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Canonical ID 63a35db7-3ab5-44ac-9f48-2d681ca736ff