Recall Z-0118-2019— AS Software, Inc.

Name: FDA recall Z-0118-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-20

Class II · Terminated

Class II FDA medical device recall by AS Software, Inc., initiated 2018-09-20, terminated 2019-04-19. It names one FDA 510(k) clearance: K051639. Product: AS-OBGYN Information System version 7.824.x. 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: AS Software, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-20
Terminated: 2019-04-19
Firm location: Englewood Cliffs, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K051639 — AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEMAs Software, Inc.·cleared 2005-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AS-OBGYN Information System version 7.824.x

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.