Class 2 Device Recall GE OEC 9900ESP Elite

• Date Initiated by Firm: August 12, 2009
• Date Posted: January 20, 2010
• Recall Status: Terminated on April 23, 2012
• Recall Number: Z-0004-2010
• Recall Event ID: 53491
• Product Classification: Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
• Product: GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
• Code Information: All associated serial numbers
• Recalling Firm/ Manufacturer: Ge Healthcare; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: Deena Pease; 801-536-4952
• Manufacturer Reason for Recall: A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.
• Quantity in Commerce: 1411 units total
• Distribution: Nationwide and Canadian Distribution
• 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.