AS-OBGYN Information System version 7 — Class II medical device recall Z-0118-2019
Terminated recall by AS Software, Inc., reported 2018-10-24, distributed nationwide. Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields
| Recall number | Z-0118-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AS Software, Inc., Englewood Cliffs, NJ, United States |
| Recall initiated | 2018-09-20 |
| Classified | 2018-10-16 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2019-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 52 systems |
| Reason classes | software |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0118-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.