Class 2 Device Recall IMPAX RIS QDOC 5.8 and higher

• Date Initiated by Firm: January 08, 2014
• Date Posted: February 03, 2014
• Recall Status: Terminated on February 28, 2014
• Recall Number: Z-0919-2014
• Recall Event ID: 67275
• 510(K)Number: K111945
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: IMPAX RIS QDOC 5.8
• Code Information: Software IMPAX RIS 58 and higher
• 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: Patient name displayed (printed) on the Patient Report was the wrong patient name.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.
• Quantity in Commerce: 14
• Distribution: CA, FL, GA, ME, OH, OR, SC, SD, TX and 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 = LLZ and Original Applicant = AGFA HEALTHCARE N.V.