Z-0118-2019Class II

AS-OBGYN Information System version 7.824.x

Name: Z-0118-2019 AS-OBGYN Information System version 7.824.x
Creator: AS Software, Inc.
Published: 2018-09-20
License: https://open.fda.gov/license/

As Software, LLC / initiated 2018-09-20 / Terminated / root cause: design

FDA source

AS Software, Inc. began a recall of AS-OBGYN Information System version 7.824.x on 2018-09-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0118-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-20
Posted: 2018-10-16
Terminated: 2019-04-19
Recalling firm: As Software, LLC
Product: AS-OBGYN Information System version 7.824.x
Product code: LLZ System, Image Processing, Radiological
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
Root cause tag: design
FDA root cause: Device Design
Action: AS Software issued letter by email on 9/20/18 to notify customers that any change made to their ultrasound machine such as software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, are tested prior to the use in the production environment. Medical Device Correction Return Response form to be signed and returned. The AS Software Support Department can be reached Monday through Friday, 9:00 AM to 6:00 PM EST via phone: 201-541-1900 option 2 or e-mail: [email protected]
Quantity in commerce: 52 systems
Distribution: US Nationwide.
Product codes and lots: Software version 7.824.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0118-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0118-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-16

Product code LLZ

K051639Class IIAs-Obgyn Information System; as-Emr SystemAs Software, Inc. / cleared 2005-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)