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Recall Observatory FDA recall evidence

Device product

AS-OBGYN Information System version 7.824.x

Z-0118-2019

September 20, 2018

Class II

Product summary

Firm
AS Software, Inc.
Event
Event 81057
Status
Terminated
Classification
Class II
Quantity
52 systems
Official record key
device-enforcement:Z-0118-2019

Official wording

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

Code information: Software version 7.824.x

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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