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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 26, 2005
Date Posted August 25, 2005
Recall Status1 Terminated 3 on June 20, 2006
Recall Number Z-1404-05
Recall Event ID 32911
510(K)Number K023020  
Product Classification Cassette, Radiographic Film - Product Code IXA
Product Radiomat Lightweight Cassettes
Code Information Product Code: EHYG2, Model: 14x17 Green RE 400 Screens and Cassettes, Product Code: EHYCT, Model: 14x17 Green RE 100 Screens and Cassettes, Product Code: EHX5C, Model: 14x17 Blue RE 800 Screens and Cassettes,  Batch number are a combination of 4 letters/numbers xxyy, where xx varies alphabetically form 6N and 6Z and from 7A to &N and yy is a number from 01 through 31. Batch numbers are located both on the cassette shell and on the outer label. 
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Jeffery A. Jedlika
864-421-1815
Manufacturer Reason
for Recall		 Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on/about 07/29/2005.
Quantity in Commerce 9055 units
Distribution Nationwide, 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 = IXA and Original Applicant = AGFA CORP.
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