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Incident · Recall

Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion

Asensus Surgical recalled the Senhance Surgical System after the Laparoscope Instrument Actuator could continue rotating after the surgeon disengaged teleoperation, an uncontrolled robotic-arm motion with potential for critical-tissue trauma. This is the first Senhance recall recorded here. Class I, 21 units. Source: FDA Class I device recall Z-0170-2024, accessdata.fda.gov; FDA recall notice fda.gov/medical-devices.

Occurred 2023-09-15 · Asensus 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?start_search=1&firmlegalnam=Asensus&postdatefrom=01/01/2023&postdateto=12/31/2026

Common questions

What happened in Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion?
Asensus Surgical recalled the Senhance Surgical System after the Laparoscope Instrument Actuator could continue rotating after the surgeon disengaged teleoperation, an uncontrolled robotic-arm motion with potential for critical-tissue trauma. This is the first Senhance recall recorded here. Class I, 21 units. Source: FDA Class I device recall Z-0170-2024, accessdata.fda.gov; FDA recall notice fda.gov/medical-devices.
When did this incident occur?
The incident is recorded as occurring on September 15, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion?
The incident is recorded as involving Asensus Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion?
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 Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion?
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 Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion.

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Canonical ID a312391b-cbf5-4d04-a2c3-8ea785108ee7