AS Software, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0118-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.
Product Description:

AS-OBGYN Information System version 7.824.x

Product Classification:

Class II

Date Initiated: September 20, 2018
Date Posted: October 24, 2018
Recall Number: Z-0118-2019
Event ID: 81057
Reason for Recall:

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

Status: Terminated
Product Quantity: 52 systems
Code Information:

Software version 7.824.x

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated