AS Software, Inc. recalls AS-OBGYN Information System version 7.824.x

Recall date

September 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0118-2019

FDA classification

Class II

Brand / firm

AS Software, Inc.

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AS-OBGYN Information System version 7.824.x