OEC Medical Systems, Inc: 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.

Recall number

Z-0341-2009

Recalling firm

OEC Medical Systems, Inc

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.

Status

Terminated

Initiated

2008-08-29

Posted

2009-01-05

Terminated

2012-04-24

Reason

Under certain conditions, x-ray system may experience operational impairment.

Root cause

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

606 units

Distribution

Nationwide, including AK, KY, NC, VA WA. and WI

Lot, serial or model codes

E2-0033, E2-0060 E2-0077,  E2-0101,  E2-0102,  E2-0106,  E2-0113,  E2-0189,  E2-0198,  E2-0202,  E2-0244,  E2-0253,  E2-0258,  E2-0262,  E2-0264,  E2-0266,  E2-0268,  E2-0270, E2-0271 E2-0272,  E2-0273,  E2-0274, .  E2-0281,  E2-0283,  E2-0284,  E2-0285,  E2-0288,  E2-0289,  E2-0290,  E2-0291,  E2-0293,  E2-0294,  E2-0296,  E2-0297,  E2-0298,  E2-0300,  E2-0302,  E2-0303,  E2-0304,  E2-0305,  E2-0308,  E2-0310,  E2-0311,  E2-0312,  E2-0314,  E2-0315,  E2-0317,  E2-0317,  E2-0318, E2-0319,  E2-0320,  E2-0321,  E2-0322,  E2-0323,  E2-0325, E2-0327,  E2-0330,  E2-0332,  E2-0333,  E2-0335,  E2-0337,  E2-0338,  E2-0340,  E2-0341,  E2-0342, E2-0345 E2-0346, E2-0348,  E2-0349,  E2-0351,  E2-0354,  E2-0357,  E2-0360,  E2-0361,  E2-0363,  E2-0364, E2-0365 E2-0366,  E2-0368,  E2-0369,  E2-0370,  E2-0371,  E2-0372,  E2-0373,  E2-0376,  E2-0377, E2-0378 E2-0379,  E2-0380,  E2-0381,  E2-0383,  E2-0384, E2-0385,  E2-0386,  E2-0387,  E2-0389,  E2-0390,  E2-0391,  E2-0392,  E2-0393,  E2-0394,  E2-0396,  E2-0398,  E2-0399,  E2-0400,  E2-0401,  E2-0402,  E2-0403,  E2-0404,  E2-0405,  E2-0406,  E2-0407,  E2-0408,  E2-0409,  E2-0410,  E2-0412,  E2-0413,  E2-0414,  E2-0415,  E2-0416,  E2-0417,  E2-0418,  E2-0419,  E2-0420,  E2-0421,  E2-0422,  E2-0423,  E2-0424,  E2-0425,  E2-0426,  E2-0427,  E2-0428,  E2-0429,  E2-0430,  E2-0431,  E2-0432,  E2-0433,  E2-0434,  E2-0435,  E2-0436,  E2-0437,  E2-0438, E2-0439,  E2-0440,  E2-0441, E2-0442,  E2-0443,  E2-0445,  E2-0448,  E2-0449 E2-0451,  E2-0452,  E2-0453,  E2-0454,  E2-0455,  E2-0456,  E2-0457,  E2-0458,  E2-0459,  E2-0461,  E2-0462,  E2-0463,  E2-0465,  E2-0466,  E2-0467,  E2-0468,  E2-0469,  E2-0470,  E2-0471,  E2-0472,  E2-0473,  E2-0474,  E2-0475,  E2-0478,  E2-0482,  E2-0483,  E2-0485,  E2-0488,  E2-0489,  E2-0490,  E2-0494,  E2-0496,  E2-0497,  E2-0498,  E2-0499,  E2-0502,  E2-0503,  E2-0504,  E2-0507,  E2-0509,  E2-0512,  E2-0513,  E2-0519,  E2-0520, E2-0525,  E2-0526,  E2-0529,  E2-0530,  E2-0532,  E2-0534,  E2-0535,  E2-0537,  E2-0538,  E2-0540,  E2-0541,  E2-0542,  E2-0546,  E2-0549, and E2-7022-MH,   E9-0002-G E9-0018,  E9-0025,  E9-0030, E9-0035-G,  E9-0043,  E9-0055,  E9-0066,  E9-0092,  E9-0094,  E9-0095,  E9-0098,  E9-0099,  E9-0101,  E9-0103,  E9-0107,  E9-0108,  E9-0109,  E9-0110, E9-0119,  E9-0121,  E9-0124,  E9-0129,  E9-0137,  E9-0138,  E9-0140,  E9-0144,  E9-0145,  E9-0150,  E9-0159,  E9-0163, E9-0166,  E9-0168, E9-0169 E9-0171,  E9-0172,  E9-0173,  E9-0174,  E9-0175,  E9-0176, E9-0177,  E9-0178,  E9-0179, E9-0185,  E9-0186,  E9-0187,  E9-0190,  E9-0191,  E9-0192,  E9-0194,  E9-0195,  E9-0197,  E9-0198,  E9-0201,  E9-0203,  E9-0204,  E9-0205,  E9-0206,  E9-0207,  E9-0208,  E9-0210,  E9-0212,  E9-0214,  E9-0215,  E9-0216,  E9-0218,  E9-0219,  E9-0220,  E9-0224,  E9-0225,  E9-0228,  E9-0231,  E9-0232,  E9-0233,  E9-0234,  E9-0235,  E9-0236,  E9-0237,  E9-0238,  E9-0239,  E9-0240,  E9-0241,  E9-0242,  E9-0243,  E9-0244,  E9-0245,  E9-0246,  E9-0255,  E9-0257,  E9-0258,  E9-0266,  E9-0267,  E9-0268,  E9-0270,  E9-0275,  E9-0277,  E9-0280,  E9-0282,  E9-0283,  E9-0284,  E9-0285,  E9-0289,  E9-0290,  E9-0292,  E9-0294,  E9-0300,  E9-0301,  E9-0306,  E9-0307,  E9-0309,  E9-0313,  E9-0314,  E9-0316,  E9-0327,  E9-0329,  E9-0332,  E9-0334,  E9-0341,  E9-0353, E9-0354,  E9-0357,  E9-0363,  E9-0372, E9-0373, E9-0375,  E9-0384,  E9-0388,  E9-0390,  E9-0391,  E9-0393,  E9-0394,  E9-0396,  E9-0398,  E9-0400,  E9-0403,  E9-0404,  E9-0405,  E9-0406,  E9-0407,  E9-0410,  E9-0411,  E9-0416,  E9-0417,  E9-0419,  E9-0420,  E9-0421, E9-0424,  E9-0425, E9-0426,  E9-0429,  E9-0436,  E9-0441,  E9-0443,  E9-0444,  E9-0445,  E9-0446,  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.

510(k) numbers

["K073542"]

PMA numbers

not on file

Product code

JAA

Firm FEI

1720753

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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