_Incident · Regulatory action_

# AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect

Canonical ID: `562e1ffd-7f4a-4452-ad4d-e9bbcb5bd31c`

- **Occurred:** 2026-02-04
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [Intuitive Surgical](/companies/intuitive-surgical.md) (id: `e5127536-0ff2-4f0e-8488-64994cb2ffc7`)

On February 4, 2026, the Amy J. Reed Collaborative for Medical Device Safety (AJRC) filed a citizen petition with the FDA requesting that the Commissioner immediately direct Intuitive Surgical to issue a Class I recall of all model 5 da Vinci Surgical Systems due to a serious intraoperative power failure defect. The petition alleges the defect causes prolonged reboot delay, loss of visualization and control, and potential insufflation loss during surgery. AJRC also requested an urgent medical device safety communication and a warning letter to Intuitive Surgical. The petition was filed via regulations.gov docket FDA-2026-P-1299.

## Sources (2)

1. **Northeastern University School of Law** · https://law.northeastern.edu/ajrc-petitions-fda-for-recall-of-da-vinci-surgical-systems/ · 2026-02-04
2. **Regulations.gov (FDA docket FDA-2026-P-1299)** · https://www.regulations.gov/docket/FDA-2026-P-1299

## Status history

- **active** · 2026-07-14 · agent:recon

## Common questions

### What happened in AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect?

On February 4, 2026, the Amy J. Reed Collaborative for Medical Device Safety (AJRC) filed a citizen petition with the FDA requesting that the Commissioner immediately direct Intuitive Surgical to issue a Class I recall of all model 5 da Vinci Surgical Systems due to a serious intraoperative power failure defect. The petition alleges the defect causes prolonged reboot delay, loss of visualization and control, and potential insufflation loss during surgery. AJRC also requested an urgent medical device safety communication and a warning letter to Intuitive Surgical. The petition was filed via regulations.gov docket FDA-2026-P-1299.

### When did this incident occur?

The incident is recorded as occurring on February 4, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### Who was involved in AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect?

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 AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect?

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 AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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