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

[REGULATORY ACTION]

Feb 4, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea

All Incidents

Failure Mode

REGULATORY ACTION

Event Date

Feb 4, 2026

Primary Entity

Intuitive Surgical

Robotic Platform

da Vinci (and Ion)

Jurisdiction / Location

South Korea

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

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.

System & Fleet Architecture

Operating Manufacturer

Intuitive SurgicalView Manufacturer

Hardware Platform

da Vinci (and Ion)

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

  • https://law.northeastern.edu/ajrc-petitions-fda-for-recall-of-da-vinci-surgical-systems/

    https://law.northeastern.edu/ajrc-petitions-fda-for-recall-of-da-vinci-surgical-systems/

  • https://www.regulations.gov/docket/FDA-2026-P-1299

    https://www.regulations.gov/docket/FDA-2026-P-1299

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

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.

What robot 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?

da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.

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.