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.