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 2025-11-07 · da Vinci (and Ion)
Machine-readable surfaces
- Markdown mirror: /incidents/davinci-instrument-arm-diagnostic-recall-2025.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/incidents/7d97d0f6-5ac1-4b4b-9727-27ed83b907a2
- Data documentation: /data
Sources (2)
- RegDataLab (FDA mirror) · https://regdatalab.com/recall/Z-1232-2026
- 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 November 7, 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 da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use?
- da Vinci (and Ion) is the recorded robot involved in this incident.
- 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 2026-06-04
Verification posture
Verified
Low confidence
Review state
Stable
Last reviewed 2026-06-04
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.Canonical ID 7d97d0f6-5ac1-4b4b-9727-27ed83b907a2