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Class 3 Device Recall Curix Opthos H |
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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
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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/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
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For Additional Information Contact |
Debbie Huff 864-421-1754
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Manufacturer Reason for Recall |
The film notch was located in the wrong position.
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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
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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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