RegWardenFDA facility compliance records
Company

AS SOFTWARE

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2018: 1 recalls20171201820192020202120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2018-09-20
    Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the …

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “AS SOFTWARE — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9074082-as-software/

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