Class 2 Device Recall DXD Imaging Package

• Date Initiated by Firm: January 16, 2012
• Date Posted: February 19, 2012
• Recall Status: Terminated on May 10, 2012
• Recall Number: Z-1062-2012
• Recall Event ID: 61052
• 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 SC 29601-2632
• 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: 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 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