Class 2 Device Recall DXD 100 MOBILE DR

• Date Initiated by Firm: May 15, 2013
• Date Posted: June 06, 2013
• Recall Status: Terminated on December 31, 2014
• Recall Number: Z-1487-2013
• Recall Event ID: 65223
• 510(K)Number: K103597
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
• Code Information: Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U
• Recalling Firm/ Manufacturer: AGFA Corp.; 10 S Academy St; Greenville SC 29601-2632
• For Additional Information Contact: Debbie Huff; 864-421-1754
• Manufacturer Reason for Recall: Customers could potentially experience intermittent, unintended and illogical movement when using the product.
• FDA Determined Cause: Under Investigation by firm
• Action: Agfa sent an "URGENT SAFETY NOTICE" letter dated May 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed if you experience unintended movement, the unit has to be taken out of operation. Please notify you Agfa service contact at once. Please distribute this information within your facility to all those who need to be aware of this. Please complete the feedback form as soon as possible and return to us. For further questions please call 1-877-777-2432.
• Quantity in Commerce: 104
• Distribution: Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
• 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 = IZL