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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9900 Elite

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 Class 2 Recall
OEC 9900 Elite
see related information
Date Posted July 18, 2012
Recall Status1 Terminated on January 28, 2013
Recall Number Z-2025-2012
Recall Event ID 62404
Premarket Notification
510(K) Number
K041932 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
Code Information Part numbers: 00-887200-01; 00-887200-03; 00-887201-01; 00-887201-03; 00-887202-01; 00-887202-03; 00-887204-03; 00-887207-03; 00-887206-03. Along with all associated 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 726 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 = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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