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Regulatory filing

fda_recall (us_fda)

Class I recall of the Asensus Senhance system after a software malfunction caused an uncontrolled arm movement; 2023.

fda recall · recalled · decided 2023-10-30


Machine-readable surfaces

Key facts

Jurisdiction
us_fda
Filing type
fda recall
Status
recalled
Filing date
2023-09-15
Decision date
2023-10-30
Verification posture
verified

Applicant

Asensus Surgical

Covered models (1)

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

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Identity

95018cab-0548-4b32-ab7d-fcca5b56c238