Class 1 Device Recall OEC 8800 Flexview,

• Date Initiated by Firm: November 20, 2006
• Date Posted: July 24, 2012
• Recall Status: Terminated on May 13, 2013
• Recall Number: Z-2065-2012
• Recall Event ID: 62387
• 510(K)Number: K003837
• Product Classification: Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
• Product: OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system ; ; ; Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
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• Recalling Firm/ Manufacturer: GE OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: Deena Pease; 801-536-4516
• Manufacturer Reason for Recall: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod
• FDA Determined Cause: Device Design
• Action: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE Healthcare sent two Urgent Recall Notice letters to the Facility Administrator and the Radiology Administrator. The letters identified the affected product, problem and actions to be taken. The letters advised consignees that GE Healthcare is actively working on solutions that will permanently resolve each of the issues. For questions or concerns contact GE Healthcare service team at 800-874-7378 option 8.
• Quantity in Commerce: 1257 units (472 domestic systems)
• Distribution: Worldwide Distribution - US Nationwide
• 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 = OXO and Original Applicant = GE OEC MEDICAL SYSTEMS