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Incident · Recall

da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use

FDA recall Z-1232-2026 (Class II; initiated Nov 7 2025, classified Feb 2 2026): a software implementation error allowed Universal Surgical Manipulator instrument arms that FAILED a diagnostic (designed to detect bent/misaligned insertion-axis ball screws, a fatigue-failure precursor) to remain in clinical use. No injuries reported. System-level recall.

Occurred 2026-02-02 · da Vinci (and Ion) at South Korea · Intuitive Surgical · South Korea · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use

Machine-readable surfaces

Outcomes (1)

  • regulatory actionverified

Revision history (2)

  • 2026-06-05 · outcome_class
  • 2026-02-02 · date_correction : 2025 (slug); occurred_at 2025 to 2026-02-02 (FDA recall Z-1232-2026 posted)

Outcome rows carry verification_posture independently. Revision events carry basis (verified_court_filing, verified_insurance, reported_press, estimate, undisclosed). The framework records outcomes only when verifiable; absence is honest absence, not a claim of no-impact.

Sources (2)

  1. RegDataLab (FDA mirror) · https://regdatalab.com/recall/Z-1232-2026
  2. SoftwareCPR · https://softwarecpr.com/2026/02/fda-recall-software-implementation-error-led-to-instrument-arms-to-fail/

Common questions

What happened in da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
FDA recall Z-1232-2026 (Class II; initiated Nov 7 2025, classified Feb 2 2026): a software implementation error allowed Universal Surgical Manipulator instrument arms that FAILED a diagnostic (designed to detect bent/misaligned insertion-axis ball screws, a fatigue-failure precursor) to remain in clinical use. No injuries reported. System-level recall.
When did this incident occur?
The incident is recorded as occurring on February 2, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in 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 da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-07-21

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

2
unclassified
Unclassified source

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

Methodology surface for da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use.

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Canonical ID 7d97d0f6-5ac1-4b4b-9727-27ed83b907a2