AS-OBGYN Information System version 7.824.x
FDA Recall Z-0118-2019 · Posted None
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Recalling FirmAS Software, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2018-09-20
Date Terminated2019-04-19
Product Quantity52 systems
Reason for Recall
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
Firm Action
AS Software issued letter by email on 9/20/18 to notify customers that any change made to their ultrasound machine such as software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, are tested prior to the use in the production environment.
Medical Device Correction Return Response form to be signed and returned.
The AS Software Support Department can be reached Monday through Friday, 9:00 AM to 6:00 PM EST via phone: 201-541-1900 option 2 or e-mail: [email protected]
Root Cause
Device Design
Distribution Pattern
US Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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