Class II — AS Software, Inc.
| Recalling firm | AS SOFTWARE |
|---|---|
| Registered facility | AS SOFTWARE, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| Product | AS-OBGYN Information System version 7.824.x |
| Quantity | 52 systems |
| Distribution | US Nationwide. |
| Initiated | 2018-09-20 |
| Classified | 2018-10-16 |
| Terminated | 2019-04-19 |
| Recall number | Z-0118-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AS Software, Inc. (Z-0118-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81057/
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