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U.S. Department of Health and Human Services

Class 2 Device Recall DXD Imaging Package

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 Class 2 Recall
DXD Imaging Package
see related information
Date Posted February 19, 2012
Recall Status1 Terminated on May 10, 2012
Recall Number Z-1062-2012
Recall Event ID 61052
Premarket Notification
510(K) Number
K092669 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.
Code Information Model Numbers DX-D 20G and DX-D 20C; Catalog Numbers ABC Code 5PYTM and 5PYUO
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Debbie Huff
864-421-1815
Manufacturer Reason
for Recall
The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot.
FDA Determined
Cause 2
DESIGN: Device Design
Action AGFA Corp. sent an "URGENT FIELD SAFETY NOTICE" letter dated January 16, 2012 to affected consignees. The letter described the affected product, concerns, issues and actions to be taken. Customers have been requested to place the Varian warning label included in a highly visible and suitable position on the cable of the portable detector. Customers were instructed to complete and return the feedback form by fax to 864-421-1664, as soon as possible. For questions about this matter contact your local AGFA HealthCare Technical Support at 877-777-2432.
Quantity in Commerce 42 units
Distribution Nationwide Distribution (USA) including the states of: FL, IL, IN, KS, MI, MN, MS, NE,NY, OH, SC and WV.
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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