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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC 9900 Elite GSP fluoroscopic xray system

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 Class 2 Recall
GE OEC 9900 Elite GSP fluoroscopic xray system
see related information
Date Posted January 05, 2009
Recall Status1 Open
Recall Number Z-0342-2009
Recall Event ID 50083
Premarket Notification
510(K) Number
K073542 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
Code Information E2-0027, E2-0047-RC, E2-0067, E2-0086, E2-0110, E2-0117, E2-0136, E2-0137, E2-0162, E2-0175, E2-0194, E2-0245, E2-0295, E2-0326, E2-0334, E2-0336, E2-0339, E2-0343, E2-0344, E2-0347, E2-0350, E2-0353, E2-0355, E2-0356, E2-0358, E2-0359, E2-0362, E2-0367, E2-0374, E2-0375, E2-0382, E2-0388, E2-0395, E2-0397, E2-0411, E2-0464, E2-0476, E2-0479, E2-0480, E2-0481, E2-0487, E2-0491, E2-0500, and E2-0501, E9-0010, E9-0011, E9-0013, E9-0019, E9-0023, E9-0026, E9-0028, E9-0036-G, E9-0039, E9-0040-G, E9-0045, E9-0048, E9-0049, E9-0057, E9-0058, E9-0063, E9-0064, E9-0067, E9-0071, E9-0078, E9-0080, E9-0081, E9-0082, E9-0083, E9-0086, E9-0088, E9-0093, E9-0115, E9-0116, E9-0120, E9-0123, E9-0126, E9-0130, E9-0141, E9-0143, E9-0149, E9-0153, E9-0155, E9-0156, E9-0156, E9-0157 E9-0158, E9-0167, E9-0180, E9-0181, E9-0184, E9-0196, E9-0202, E9-0217, E9-0221, E9-0222, E9-0223, E9-0226, E9-0227, E9-0229, E9-0230, E9-0256, E9-0259, E9-0263, E9-0269, E9-0271, E9-0272, E9-0273, E9-0274, E9-0276, E9-0278, E9-0279, E9-0281, E9-0286, E9-0287, E9-0288, E9-0291, E9-0293, E9-0295, E9-0296, E9-0297, E9-0298, E9-0299, E9-0302, E9-0303, E9-0304, E9-0305, E9-0308, E9-0310, E9-0311, E9-0312, E9-0315, E9-0317, E9-0318, E9-0319, E9-0320, E9-0321, E9-0322, E9-0323, E9-0324, E9-0325, E9-0326, E9-0328, E9-0330, E9-0331, E9-0333, E9-0335, E9-0336, E9-0337, E9-0338, E9-0339, E9-0340, E9-0342, E9-0343, E9-0344, E9-0345, E9-0346, E9-0347, E9-0348, E9-0349, E9-0350, E9-0351, E9-0352, E9-0355, E9-0356, E9-0358, E9-0359, E9-0360, E9-0361, E9-0362, E9-0364, E9-0365, E9-0366, E9-0367, E9-0368, E9-0369, E9-0370, E9-0371, E9-0374, E9-0376, E9-0377, E9-0378, E9-0379, E9-0380, E9-0381, E9-0382, E9-0383, E9-0385, E9-0386, E9-0387, E9-0389, E9-0392, E9-0397, E9-0399, E9-0401, E9-0402, E9-0408, E9-0409, E9-0411, E9-0412, E9-0413, E9-0414, E9-0415, E9-0418, E9-0422, E9-0423, E9-0427, E9-0428, E9-0430, E9-0431, E9-0432, E9-0433, E9-0434, E9-0435, E9-0437, E9-0438, E9-0439, E9-0440, E9-0442, E9-0451, E9-0454, E9-0455, E9-0460, E9-0467, E9-0468, E9-0469, E9-0470, E9-0473, E9-0476, E9-0478, E9-0480, E9-0484, E9-0485, E9-0487, E9-0489, E9-0490, E9-0491, E9-0496, E9-0500, E9-0503, E9-0508, E9-0510, E9-0512, E9-0517, E9-0518, E9-0520, E9-0521, E9-0526, E9-0528, E9-0537, E9-0538, E9-0544, E9-0549, and E9-0009, ES-0029-CH ES-0030, ES-0037, ES-0039, ES-0048, ES-0051, ES-0057, ES-0060-H, ES-0064, ES-0065, ES-0066-CH ES-0073, ES-0076, ES-0089, ES-0090, ES-0096, ES-0106, ES-0108, ES-0120, ES-0121, ES-0123, ES-0124, ES-0125, ES-0126, ES-0128, ES-0135, ES-0139, ES-0147, ES-0170, ES-0172, ES-0181, ES-0183, ES-0187, ES-0197, ES-0208, ES-0213, ES-0214, ES-0215, ES-0221, ES-0222, ES-0223, ES-0229, ES-0230, ES-0231, ES-0232, ES-0233, ES-0235, ES-0237, ES-0240, ES-0241, ES-0243, ES-0244, ES-0247, ES-0248, ES-0249, ES-0250, ES-0251, ES-0252, ES-0256, ES-0257, ES-0258, ES-0259, ES-0260, ES-0261, ES-0263, ES-0264, ES-0265, ES-0267, ES-0268, ES-0269, ES-0270, ES-0271, ES-0276, ES-0277, ES-0278, ES-0282, ES-0283, ES-0284, ES-0285, ES-0286, ES-0287, ES-0288, ES-0289, ES-0290, ES-0291, ES-0293, ES-0294, ES-0295, ES-0296, ES-0297, ES-0298, ES-0301, ES-0302, ES-0303, ES-0304, ES-0305, ES-0306, ES-0307, ES-0308, ES-0309, ES-0310, ES-0311, ES-0313, ES-0314, ES-0315, ES-0317, ES-0318, ES-0319, ES-0320, ES-0323, ES-0324, ES-0325, ES-0327, ES-0328, ES-0329, ES-0330, ES-0331, ES-0333, ES-0334, ES-0338, ES-0339, ES-0340, ES-0341, ES-0344, ES-0345, ES-0346, ES-0347, ES-0348, ES-0350, ES-0353, ES-0356, ES-0357, ES-0361, ES-0362, ES-0368, ES-0369, ES-0370, ES-0371, ES-0372, ES-0373, ES-0386, ES-0388, ES-0389, ES-0392, ES-0393, ES-0395, ES-0396 ES-0397, ES-0398, ES-0406, ES-0407, ES-0408, ES-0409, ES-0410, ES-0411, ES-0414, ES-0416, ES-0420, ES-0424, ES-0426, ES-0432, ES-0440, ES-0447, ES-0448, ES-0449, ES-0453, ES-0457, ES-0466, ES-0470, ES-0471, ES-0473, ES-0474, ES-0475, ES-0477, ES-0481, ES-0489, ES-0491, ES-0492, ES-0503, ES-0504, ES-0505, ES-0507, ES-0508, ES-0516, ES-0517, ES-0519, ES-0520, ES-0530, ES-0531, ES-0537, ES-0540, ES-0542, ES-0543, ES-0546, ES-0548, ES-7002-MH, and ES-7029-MH.
Recalling Firm/
Manufacturer
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 Deena Pease
801-536-4952
Manufacturer Reason
for Recall
Under certain conditions, x-ray system may experience operational impairment.
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.
Quantity in Commerce 448 units
Distribution Nationwide, including AK, KY, NC, VA WA. and WI
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 = PT PRODUCTS, LLC
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