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Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments

Intuitive recalled da Vinci X/Xi systems (IS4000) because inadvertent energy delivery could occur from the surgical instrument when used with Force bipolar instruments. 162 systems. Source: FDA Class 2 device recall Z-0133-2023, openFDA enforcement / accessdata.fda.gov.

Occurred 2022-09-20 · Intuitive Surgical · 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.
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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=211968

Common questions

What happened in Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments?
Intuitive recalled da Vinci X/Xi systems (IS4000) because inadvertent energy delivery could occur from the surgical instrument when used with Force bipolar instruments. 162 systems. Source: FDA Class 2 device recall Z-0133-2023, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on September 20, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments?
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 Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments?
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 Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

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

Methodology surface for Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments.

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Canonical ID b4656bc7-ce05-45d5-b33c-09cd2c492825