Class 2 Device Recall IMPAX

• Date Initiated by Firm: September 19, 2013
• Date Posted: October 21, 2013
• Recall Status: Terminated on October 24, 2013
• Recall Number: Z-0035-2014
• Recall Event ID: 66424
• 510(K)Number: K071297
• Product Classification: Picture Archiving and Communication System (PACS). - Product Code LLZ
• Product: IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
• Code Information: N/A
• 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: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
• FDA Determined Cause: Software in the Use Environment
• Action: An "URGENT FIELD SAFETY NOTICE" letter was sent via email to the consignees on 9/19/2013, Acknowledgement, via FAX-Back or email, that the information was received and understood has been requested from the consignees. The letter specifically describes the safety alert for the device, informs consignees of the problem and recommends the upgrades for IMPAX and Oracle.
• Quantity in Commerce: 4
• Distribution: Worldwide distrbution: US(nationwide) distribution including NY and OK, and 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 = LLZ