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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 8800

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 Class 2 Recall
OEC 8800
see related information
Date Posted July 18, 2012
Recall Status1 Terminated on January 28, 2013
Recall Number Z-2027-2012
Recall Event ID 62404
Premarket Notification
510(K) Number
K003837 
Product Classification Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Code OXO
Product OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Code Information Part numbers: OEC 8800 All serial numbers.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Deena Pease
801-536-4952
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. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
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 an"URGENT RECALL NOTICE" dated February 22, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 800-874-7378 for questions concerning this recall.
Quantity in Commerce 1349 units
Distribution Worldwide Distribution.
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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