Reported Oct 24, 2018 · Terminated

AS-OBGYN Information System version 7.824.x

AS Software, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AS Software, Inc. · 560 Sylvan Ave · Englewood Cliffs, NJ · 07632-3119

Is this the product you have?

  • AS-OBGYN Information System version 7.824.x
Lot codes and dates
  • Software version 7.824.x
Amount recalled
52 systems

Where it was sold

  • Nationwide

Why it was recalled

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 AS system

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 19, 2019 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.