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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 Device Recall GE OEC 9900 Elite GSP fluoroscopic xray system see related information
Date Posted January 05, 2009
Recall Status1 Terminated on April 24, 2012
Recall Number Z-0342-2009
Recall Event ID 50083
510(K)Number K073542 
Product Classification Fluoroscopic x-ray system - 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 -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 UT 84116-2862
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
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.
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