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U.S. Department of Health and Human Services

Class 2 Device Recall DXG Digitizer

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 Class 2 Recall
DXG Digitizer
see related information
Date Posted November 26, 2010
Recall Status1 Terminated on December 30, 2010
Recall Number Z-0464-2011
Recall Event ID 57109
Premarket Notification
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, South Carolina 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/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = AGFA HEALTHCARE N.V.
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