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AS Software, Inc. recalls AS-OBGYN Information System version 7.824.x
Recalled October 24, 2018 · FDA recall Z-0118-2019 · AS Software
Hazard
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 · FDA Class II
Units
52 systems
Sold at
US Nationwide.
Description
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
Product
AS-OBGYN Information System version 7.824.x
Manufacturer(s)
AS Software, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →