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U.S. Department of Health and Human Services

Class 3 Device Recall Radiomat

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  Class 3 Device Recall Radiomat see related information
Date Initiated by Firm February 16, 2006
Date Posted April 11, 2006
Recall Status1 Terminated 3 on June 22, 2006
Recall Number Z-0756-06
Recall Event ID 34890
Product Classification Medical Screen X-Ray Film - Product Code JAC
Product Radiomat¿ SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box
Code Information Product Code: EK8JR, Manufacturing Batch or Lot: 79360104 and Product Code: EK8DG, Manufacturing Batch or Lot: 79360104 
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
864-864-1827
Manufacturer Reason
for Recall		 A localized fog pattern appears on the film.
FDA Determined
Cause 2		 Other
Action Consignees were notified by telephone on 02/16/2006.
Quantity in Commerce 712 stacks (total includes all types of film)
Distribution AL, AZ, CA, CO, FL, GA, IN, MA, MI, NC, NJ, NY, OR, SC, TN, TX, WA, VA 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.
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