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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.x see related information
Date Initiated by Firm September 20, 2018
Create Date October 16, 2018
Recall Status1 Terminated 3 on April 19, 2019
Recall Number Z-0118-2019
Recall Event ID 81057
510(K)Number K051639  
Product Classification System, image processing, radiological - Product Code LLZ
Product AS-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 Contact sane 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
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: info@as-software.com
Quantity in Commerce 52 systems
Distribution US Nationwide.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = AS SOFTWARE, INC.
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