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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall GE OEC 9900 Elite ESP fluoroscopic xray system see related information
Date Posted January 05, 2009
Recall Status1 Terminated on April 24, 2012
Recall Number Z-0341-2009
Recall Event ID 50083
510(K)Number K073542 
Product Classification Fluoroscopic x-ray system - Product Code JAA
Product GE OEC 9900 Elite ESP 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 E9-0447,
E9-0448,
E9-0449,
E9-0450,
E9-0452,
E9-0456,
E9-0457,
E9-0458,
E9-0459,
E9-0461,
E9-0463,
E9-0464,
E9-0465,
E9-0466,
E9-0471,
E9-0472,
E9-0474,
E9-0475,
E9-0477,
E9-0479,
E9-0481,
E9-0482,
E9-0483,
E9-0486,
E9-0488,
E9-0492,
E9-0494,
E9-0495,
E9-0497,
E9-0499,
E9-0501,
E9-0502,
E9-0511,
E9-0513,
E9-0515,
E9-0516,
E9-0524,
E9-0530,
E9-0532,
E9-0533,
E9-0540,
E9-0541,
E9-0542,
E9-0543,
E9-0545,
E9-0551,
E9-0554, and
E9-0557,

ES-0013-G,
ES-0019,
ES-0050,
ES-0054,
ES-0103,
ES-0110,
ES-0113,
ES-0114,
ES-0115,
ES-0117,
ES-0118,
ES-0130,
ES-0134,
ES-0160,
ES-0176,
ES-0180, ES-0188,
ES-0189,
ES-0192,
ES-0198,
ES-0199,
ES-0203,
ES-0206,
ES-0207,
ES-0211,
ES-0216,
ES-0217,
ES-0218,
ES-0219,
ES-0220,
ES-0224,
ES-0225,
ES-0226,
ES-0227,
ES-0228,
ES-0234,
ES-0236,
ES-0238,
ES-0239,
ES-0253,
ES-0254,
ES-0255,
ES-0262,
ES-0266,
ES-0272,
ES-0273,
ES-0274,
ES-0275,
ES-0279,
ES-0280,
ES-0281, ES-0292,
ES-0299,
ES-0300,
ES-0312,
ES-0316,
ES-0321,
ES-0322,
ES-0326, ES-0332,
ES-0335,
ES-0336,
ES-0337,
ES-0342,
ES-0343,
ES-0349,
ES-0351,
ES-0352,
ES-0354,
ES-0355, ES-0358,
ES-0359,
ES-0360,
ES-0363,
ES-0364,
ES-0365,
ES-0366,
ES-0367,
ES-0374,
ES-0375,
ES-0376,
ES-0377,
ES-0378,
ES-0379, ES-0380,
ES-0381,
ES-0382,
ES-0383,
ES-0384,
ES-0385,
ES-0387,
ES-0390,
ES-0391,
ES-0394,
ES-0396,
ES-0399,
ES-0400,
ES-0401,
ES-0402,
ES-0403,
ES-0404,
ES-0405,
ES-0412,
ES-0413,
ES-0415,
ES-0417,
ES-0418,
ES-0419,
ES-0421,
ES-0422,
ES-0423,
ES-0425,
ES-0427,
ES-0428,
ES-0429,
ES-0430,
ES-0431,
ES-0433,
ES-0434,
ES-0435,
ES-0436,
ES-0437,
ES-0438,
ES-0439,
ES-0441,
ES-0442,
ES-0443,
ES-0444,
ES-0445,
ES-0446,
ES-0450,
ES-0451,
ES-0452,
ES-0454,
ES-0455,
ES-0458,
ES-0459,
ES-0460,
ES-0462,
ES-0463,
ES-0464,
ES-0465,
ES-0467,
ES-0468,
ES-0469,
ES-0472,
ES-0476,
ES-0478,
ES-0479,
ES-0480,
ES-0482,
ES-0483,
ES-0484,
ES-0485,
ES-0486,
ES-0487,
ES-0488,
ES-0490,
ES-0493,
ES-0494,
ES-0495,
ES-0496,
ES-0497,
ES-0498,
ES-0499,
ES-0500,
ES-0501,
ES-0502,
ES-0509,
ES-0510,
ES-0513,
ES-0514,
ES-0515,
ES-0518,
ES-0521,
ES-0522,
ES-0523,
ES-0526,
ES-0527,
ES-0528,
ES-0529,
ES-0532,
ES-0533,
ES-0536,
ES-0538,
ES-0544,
ES-0547,
ES-0549,
ES-0552,
ES-0553, and
ES-0561.
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 606 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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