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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/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Jeffery A. Jedlika
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
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.