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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.