FDA Medical Device Recalls (openFDA)
AS Software, Inc.: AS-OBGYN Information System version 7.824.x
- Recall number
- Z-0118-2019
- Recalling firm
- AS Software, Inc.
- Product
- AS-OBGYN Information System version 7.824.x
- Status
- Terminated
- Initiated
- 2018-09-20
- Posted
- not on file
- Terminated
- 2019-04-19
- 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
- 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: info@as-software.com
- Quantity
- 52 systems
- Distribution
- US Nationwide.
- Lot, serial or model codes
- Software version 7.824.x
- 510(k) numbers
- ["K051639"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3005207094
- Firm city
- Englewood Cliffs
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28