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U.S. Department of Health and Human Services

Class 3 Device Recall Curix Opthos H

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  Class 3 Device Recall Curix Opthos H see related information
Date Initiated by Firm October 04, 2011
Date Posted November 25, 2011
Recall Status1 Terminated 3 on December 22, 2011
Recall Number Z-0285-2012
Recall Event ID 60166
Product Classification Film, radiographic - Product Code IWZ
Product Curix Opthos H, size 35x43 cm

A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information.
Code Information 79890049
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
Manufacturer Reason
for Recall
The film notch was located in the wrong position.
FDA Determined
Cause 2
Process control
Action An "URGENT SAFETY NOTICE" letter was sent via email to the dealers on October 7, 2011. The letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the dealer sites. Included in each dealer letter, Agfa also provided a customer notification letter to be sent to their end-use customers. Agfa has requested dealers and end-use customers to file a complaint at 1-877-777-2432 for any identified product still in their inventories. Agfa will replace product and arrange for return shipment.
Quantity in Commerce 125
Distribution Worldwide Distribution -- USA, including the states of IN, KS, MI, MN, MO, NC, NE, NY, OH, and TN and the country of 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.