Class 2 Device Recall Agfa Impax System

• Date Initiated by Firm: July 16, 2009
• Date Posted: September 08, 2009
• Recall Status: Terminated on April 28, 2011
• Recall Number: Z-1887-2009
• Recall Event ID: 52757
• 510(K)Number: K022292
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.
• Code Information: Product Version 6.3.1 SU10.
• Recalling Firm/ Manufacturer: AGFA Corp.; 10 S Academy St; Greenville SC 29601-2632
• For Additional Information Contact: Jeffery A. Jedlicka; 864-421-1815
• Manufacturer Reason for Recall: Measurements are inaccurate on multiple workstations.
• FDA Determined Cause: Software design
• Action: Agfa Healthcare issued an "URGENT FIELD SAFETY NOTICE" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm. For further information, contact Agfa Healthcare at 1-773-592-4769.
• Quantity in Commerce: One unit
• Distribution: Nationwide Distribution -- IL
• 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