Class 2 Device Recall "NX" Modality Workstation

• Date Initiated by Firm: March 04, 2011
• Date Posted: May 04, 2011
• Recall Status: Terminated on March 27, 2012
• Recall Number: Z-2137-2011
• Recall Event ID: 58166
• 510(K)Number: K071162
• Product Classification: NX - Image Acquisition and Processing Station - Product Code MQB
• Product: NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.
• Code Information: Software Versions: 2.0.8100, 3.0.8100, 2.0.8200, 3.0.8200, 2.0.8300, 3.0.8300, 2.0.8400, 3.0.8400, 2.0.8500, and 3.0.8500
• 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: When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.
• FDA Determined Cause: Other
• Action: AGFA Corp. sent an "URGENT FIEL SAFETY NOTICE" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664. For questions regarding this recall call 864-421-1815.
• Quantity in Commerce: 775 units
• Distribution: Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA 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 = MQB