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U.S. Department of Health and Human Services

Class 3 Device Recall Mamoray

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  Class 3 Device Recall Mamoray see related information
Date Initiated by Firm February 16, 2006
Date Posted April 22, 2006
Recall Status1 Terminated 3 on June 23, 2006
Recall Number Z-0788-06
Recall Event ID 34773
Product Classification Mammography film - Product Code IWZ
Product Mamoray¿ HDR-C PLUS Mammography film
Code Information Product Code: EMLOV, Batch 37300052
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Customer Support Center
Manufacturer Reason
for Recall
The film was incorrectly notched.
FDA Determined
Cause 2
Action Consignees were notified by letter on/about 02/16/2006.
Quantity in Commerce 16523 units
Distribution 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.