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U.S. Department of Health and Human Services

Class 2 Device Recall DXG Digitizer

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  Class 2 Device Recall DXG Digitizer see related information
Date Initiated by Firm October 08, 2010
Date Posted November 26, 2010
Recall Status1 Terminated 3 on December 30, 2010
Recall Number Z-0464-2011
Recall Event ID 57109
510(K)Number K092238  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
Code Information Model 5170/100
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Norris
864-421-1754
Manufacturer Reason
for Recall		 Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.
FDA Determined
Cause 2		 Other
Action Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.
Quantity in Commerce One unit
Distribution Nationside Distribution: to NJ.
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 = MQB and Original Applicant = AGFA HEALTHCARE N.V.
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