Class 2 Device Recall OEC 9800 Plus

• Date Initiated by Firm: February 09, 2007
• Date Posted: March 22, 2007
• Recall Status: Terminated on June 26, 2007
• Recall Number: Z-0558-2007
• Recall Event ID: 37322
• 510(K)Number: K021049 K022069 K024012
• Product Classification: Image-intensified fluoroscopic x-ray system. - Product Code JAA
• Product: OEC 9800 Plus Fluoroscopic X-ray System,
• Code Information: Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.
• Recalling Firm/ Manufacturer: GE OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: Ms. Karen Tolson; 847-501-1884
• Manufacturer Reason for Recall: During routine service, a cover may have been installed without the required proper lead shielding.
• FDA Determined Cause: Other
• Action: Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
• Quantity in Commerce: 11 units of all models
• Distribution: Nationwide to AL, AZ, IA, OH, TX, VA, and WV.
• 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 = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS