AS-OBGYN Information System Software Recall for Ultrasound Data Transfer Issues
AS Software, Inc. is recalling 52 systems of AS-OBGYN Information System version 7.824.x because ultrasound measurements may not transfer correctly to the system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect clinical data (ultrasound measurements), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
AS Software, Inc. is recalling 52 systems of the AS-OBGYN Information System, version 7.824.x. The recall is due to a software issue where ultrasound measurements may not cross over correctly to the AS system.
The affected software is distributed nationwide in the United States. The source text notes that changes to ultrasound machine software or hardware, adding custom fields, or adding new machines must be tested to ensure correct data transfer, implying that the current version may fail to do so reliably.
Healthcare providers using this software should verify that ultrasound data is transferring correctly. Users should contact AS Software, Inc. for further instructions on how to resolve the data transfer issue.
The recalled product
- Product
- AS-OBGYN Information System version 7.824.x
- Manufacturer
- AS Software, Inc.
- Category
- Medical Device — Software
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version 7.824.x
Distribution
Distributed nationwide across the United States.
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