FDA-Device2018-10-24Class II
AS-OBGYN Information System version 7.824.x
AS Software, Inc.
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
Sold states
US Nationwide.
Affected count
52 systems
Manufactured in
560 Sylvan Ave, N/A, Englewood Cliffs, NJ, United States
Products
AS-OBGYN Information System version 7.824.x
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2019Don't want to check this manually?
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