# FDA recall Z-0118-2019

> **AS Software, Inc.** · Class II · device recall initiated 2018-09-20.

## 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

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-0118-2019
- **Recalling firm:** AS Software, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-20
- **Report date:** 2018-10-24
- **Termination date:** 2019-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Englewood Cliffs, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2019

## Citation

> AI Analytics. FDA recall Z-0118-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0118-2019. Source: US FDA. Licensed CC0.

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