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U.S. Department of Health and Human Services

Class 1 Device Recall OEC 8800 Flexview,

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 Class 1 Recall
OEC 8800 Flexview,
see related information
Date Posted July 24, 2012
Recall Status1 Terminated on May 13, 2013
Recall Number Z-2065-2012
Recall Event ID 62387
Premarket Notification
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, Utah 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = GE OEC MEDICAL SYSTEMS
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