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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.