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U.S. Department of Health and Human Services

Class 3 Device Recall Advance Medical Equipment Cover

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  Class 3 Device Recall Advance Medical Equipment Cover see related information
Date Initiated by Firm June 18, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 03, 2004
Recall Number Z-1036-04
Recall Event ID 29375
510(K)Number K850959  
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Advance¿ Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.
Code Information Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154
Recalling Firm/
Manufacturer
Advance Medical Designs Inc
1241 Atlanta Industrial Dr
Marietta GA 30066-6606
For Additional Information Contact Mr. Mike Tomberlin
770-422-3125 Ext. 243
Manufacturer Reason
for Recall
The product may come apart when excessive force is applied to the coupler.
FDA Determined
Cause 2
Other
Action Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04.
Quantity in Commerce 2340 units, *amended to include additional 250 units
Distribution Nationwide and Canada
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 = JAA and Original Applicant = ADVANCE MEDICAL DESIGNS, INC.
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