Recall – OBGYN Information System

Company: AS Software, Inc
Date of Enforcement Report 10/24/2018
Class II:

PRODUCT
AS-OBGYN Information System version 7.824.x

Recall Number: Z-0118-2019

REASON
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.

RECALLING FIRM/MANUFACTURER
AS Software, Inc. Englewood Cliffs, NJ on 9/20/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
52 systems

DISTRIBUTION
US Nationwide.

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