FDASeptember 20, 2018device
AS-OBGYN Information System version 7.824.x
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
as software
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMIM software; System, Image Processing, Radiological2025-02-19
- FDAMOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.2019-09-24
- CPSCVernier Software & Technology Recalls Circuit Boards Due to Burn Hazard (Recall Alert)2018-06-06
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