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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

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.

Occurred 2026-02-04 · 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 AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect

Machine-readable surfaces

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.
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.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-07-14

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

2
unclassified
Unclassified source

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

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

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