Englewood Cliffs, NJ, United States
AS Software, Inc. recalls
1 recall recorded since 2018, most recently on 20 September 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 September 2018
- Terminated
- 19 April 2019
- 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
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0118-2019
- AS-OBGYN Information System version 7.824.x
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.