_Incident · Recall_

# 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`

- **Occurred:** 2025-11-07
- **Kind:** `recall`
- **Status (derived):** active
- **Model:** [da Vinci (and Ion)](/models/intuitive-da-vinci.md) (id: `45105ba4-1c1f-4121-9ad4-bb912db1dcfc`)

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.

## 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 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.


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