The Recall Desk
HighFDA (Devices)·Z-0118-2019·Announced 2018-10-24

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.

What this means for you

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
Hazard
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.

Related recalls

Same hazard · data integrity

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