FDA Device recall Z-0118-2019
AS-OBGYN Information System version 7.824.x
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of AS-OBGYN Information System version 7.824.x by As Software, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0118-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-20 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | As Software |
| Distribution | US |
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
Identifiers
| code_info | Software version 7.824.x |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2019%22
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