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U.S. Department of Health and Human Services

Class 2 Device Recall ASOBGYN Information System version 7.824.x

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 Class 2 Device Recall ASOBGYN Information System version 7.824.xsee related information
Date Initiated by FirmSeptember 20, 2018
Create DateOctober 16, 2018
Recall Status1 Terminated 3 on April 19, 2019
Recall NumberZ-0118-2019
Recall Event ID 81057
510(K)NumberK051639 
Product Classification System, image processing, radiological - Product Code LLZ
ProductAS-OBGYN Information System version 7.824.x
Code Information Software version 7.824.x
Recalling Firm/
Manufacturer		 AS Software, Inc.
560 Sylvan Ave
Englewood Cliffs NJ 07632-3119
For Additional Information Contactsane Lewis
201-541-1900
Manufacturer 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
FDA Determined
Cause 2		Device Design
ActionAS 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: info@as-software.com
Quantity in Commerce52 systems
DistributionUS Nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
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