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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
Recall Number Z-2241-2012
Classification Class II
Code Info Serial numbers: 69-0128, 82-0157, 82-0158, 82-0185, 82-0191, 82-0210, 82-0215, 82-0223, 82-0229, 82-0266, 82-0324, 82-0328, 82-0464, 82-0477, 82-0484, 82-0505-RC, 82-0507, 82-0542, 82-0544, 82-0546, 82-0551, 82-0604, 82-0648, 82-0673, 82-0680, 82-0714, 82-0733, 82-0779, 82-0858, 82-0869, 82-0884, 82-0906, 82-0918, 82-0965, 82-1004, 82-1009, 82-1057-RC, 82-1070, 82-1139, 82-1191, 82-1194, 82-1225, 82-1247, 82-1303, 82-1405, 82-1434, 82-1458, 82-1480, 82-1534, 82-1547-RC, 82-1564, 82-1585, 82-1588, 82-1601, 82-1604, 82-1621, 82-1694, 82-1695, 82-1699, 82-1797, 82-1798, 82-1842, 82-1850, 82-1921, 82-1959, 82-2015, 82-2120, 82-2192, 82-2245, 82-2247, 82-2274, 82-2277, 82-2306, 82-2386, 82-2487, 82-2661, 82-2662, 82-2716, 82-2721, 82-2741, 82-2745, 82-2797, 82-2846, 82-2905, 82-2965, 82-3102, 82-3107, 82-3122, 82-3135, 82-3151, 82-3351, 82-3366, 82-3403, 82-3431, 82-3492, 82-3498, 82-3563, 82-3570, 82-3614, 82-3634, 82-3762, 82-3815, 82-3819, 82-3824, 82-3839, 82-3851, 82-3882, 82-3884, 82-3887, 82-3888, 82-3890, 82-3894, 82-3895, 82-3896, 82-3898, 82-3899, 82-3901, 82-3903, 82-3904, 82-3910, 82-3911, 82-3912, 82-3913, 82-3914, 82-3915, 82-3917, 82-3919, 82-3920, 82-3921, 82-3922, 82-3923, 82-3925, 82-3928, 82-3929, 82-3930, 82-3931, 82-3933, 82-3934, 82-3935, 82-3936, 82-3937, 82-3938, 82-3939, 82-3941, 82-3942, 82-3943, 82-3944, 82-7011-MH, 82-7024-MH, 82-7154-CMH, 82-7189-MH, 82-7190-MH, 82-7191-MH, 82-7197-MH, 82-7200-MH, 82-7206-MH, 89-0100, 89-0128, 89-0135-RC, 89-0210, 89-0248, 89-0315, 89-0362, 89-0385, 89-0401, 89-0416, 89-0457, 89-0464, 89-0467, 89-0505, 89-0506, 89-0537, 89-0556, 89-0559, 89-0577, 89-0612, 89-0643, 89-0660, 89-0662, 89-0729, 89-0738, 89-0780, 89-0781, 89-0832, 89-0853, 89-0868, 89-0876, 89-0882, 89-0922, 89-0954-RC, 89-0963, 89-1040, 89-1071, 89-1172, 89-1195, 89-1228, 89-1245, 89-1248, 89-1255, 89-1262, 89-1268, 89-1271, 89-1274, 89-1286, 89-1295, 89-1308, 89-1343, 89-1373, 89-1400-RC, 89-1408, 89-1426, 89-1494, 89-1531, 89-1576, 89-1598, 89-1606, 89-1612, 89-1640, 89-1663, 89-1673, 89-1721, 89-1729, 89-1739, 89-1749, 89-1868, 89-2121, 89-2259, 89-2264, 89-2275, 89-2309, 89-2315, 89-2350, 89-2354, 89-2456, 89-2464, 89-2500, 89-2680, 89-2866, 89-3211, 89-3294, 89-3312, 89-3349, 89-3352, 89-3355, 89-3377, 89-3420, 89-3433, 89-3461, 89-3479, 89-3483, 89-3488, 89-3490, 89-3494, 89-3495, 89-3499, 89-3501, 89-3504, 89-3508, 89-3509, 89-3511, 89-3512, 89-3513, 89-3514, 89-3515, 89-3519, 89-3520, 89-3522, 89-3524, 89-3527, 89-3529, 89-3530, 89-3533, 89-3537, 89-3538, 89-3539, 89-3543, 89-3544, 89-3545, 89-3546, 89-3547, 89-3548, 89-3549, 89-3551, 89-3552, 89-3553, 89-3554, 89-3555, 89-3556, 89-3557, 89-3558, 89-3559, 89-3560, 89-3561, 89-3562, 89-3563, 89-3564, 89-3565, 89-3567, 89-3568, 89-3569, 89-3570, 89-3571, 89-3572, 89-3573, 89-3574, 89-3578, 89-3579, 8S-0027, 8S-0076-RC, 8S-0086, 8S-0121-C, 8S-0158, 8S-0165, 8S-0245, 8S-0291, 8S-0301-C, 8S-0315, 8S-0413-C, 8S-0494, 8S-0615-C, 8S-0642, 8S-0691, 8S-0707, 8S-0711, 8S-0735, 8S-0747, 8S-0776, 8S-0840, 8S-0844-RC, 8S-0858, 8S-0867, 8S-0872, 8S-0921, 8S-0974, 8S-1013-C, 8S-1046, 8S-1056, 8S-1058, 8S-1065-C, 8S-1174, 8S-1203, 8S-1224-C-RC, 8S-1285-RC, 8S-1360, 8S-1445, 8S-1644, 8S-1856, 8S-1930-N, 8S-1954, 8S-1959, 8S-1961, 8S-2052, 8S-2053, 8S-2063, 8S-2063, 8S-2113, 8S-2145, 8S-2164, 8S-2170, 8S-2207, 8S-2256, 8S-2329, 8S-2439, 8S-2451, 8S-2452, 8S-2452, 8S-2462, 8S-2532, 8S-2622, 8S-2865, 8S-2956, 8S-2985, 8S-3002, 8S-3108, 8S-3111, 8S-3112, 8S-3130, 8S-3179, 8S-3183, 8S-3197, 8S-3205, 8S-3207, 8S-3211-CH, 8S-3216, 8S-3222, 8s-3231, 8S-3233, 8S-3243, 8S-3245, 8S-3246, 8S-3247, 8S-3248, 8S-3249, 8S-3253, 8S-3254, 8S-3255, 8S-3256-H, 8S-3257, 8S-3258-CH, 8S-3259, 8S-3260, 8S-3261, 8S-3262, 8S-3263, 8S-3264, 8S-3265, 8S-3266, 8S-3267, 8S-3268, 8S-3269-H, 8S-3270-H, 8S-3271-H, 8S-3272-H, 8S-3273-CH, 8S-3274-CH, 8S-3275, 8S-3276, 8S-3278, 8S-3279, 8S-3280, 8S-3281, 8S-3282, 8S-3283, 8S-3285, 8S-3286, 8S-3287, 8S-3288-H, 8S-3289-H, 8S-3291, 8S-3292, 8S-3296, 8S-3299, 8S-3301-H, 8S-3302, 8S-3305, 8S-3306, 8S-3307, 8S-3308, 8S-3309, 8S-3310-H, 8S-3311, 8S-3315, 8S-7094-CMH, 8S-7228-CMH, 8S-7229-CMH, 8S-7230-CMH, 8S-7231-MH, 8S-7232-MH, 8S-7233-MH, E2-0001, E2-0015, E2-0026, E2-0028, E2-0034, E2-0078, E2-0084, E2-0085, E2-0108, E2-0110, E2-0111, E2-0117, E2-0120, E2-0122, E2-0130, E2-0142, E2-0143, E2-0148, E2-0151, E2-0152, E2-0153, E2-0154, E2-0155, E2-0156, E2-0157, E2-0158, E2-0159, E2-0160, E2-0161, E2-0162, E2-0163, E2-0164, E2-0165, E2-0167, E2-0168, E2-0169, E2-0171, E2-0172, E2-0173, E2-0174, E2-0175, E2-0176, E2-0177, E2-0178, E2-0179, E2-0180, E2-0181, E2-0182, E2-0183, E2-0184, E2-0185, E2-0186, E2-0187, E2-0188, E2-0189, E2-0190, E2-0191, E2-0192, E2-0193, E2-0194, E2-0195, E2-0196, E2-0197, E2-0198, E2-0199, E2-0200, E2-0201, E2-0202, E2-0203, E2-0204, E2-0205, E2-0206, E2-0207, E2-0208, E2-0209, E2-0210, E2-0211, E2-0212, E2-0213, E2-0215, E2-0216, E2-0217, E2-0222, E2-0224, E2-0225, E2-0230, E2-0231, E2-0232, E2-0233, E2-0234, E2-0235-C, E2-0237, E2-0238, E2-0239, E2-0240, E2-0241, E2-0242, E2-0243, E2-0244, E2-0245, E2-0246, E2-0247, E2-0248, E2-0250, E2-0251, E2-0252, E2-0253, E2-0254, E2-0255, E2-0256, E2-0257, E2-0258, E2-0259, E2-0260, E2-0261, E2-0262, E2-0263, E2-0264, E2-0265, E2-0266, E2-0267, E2-0268, E2-0269, E2-0270, E2-0271, E2-0272, E2-0273, E2-0274, E2-0275, E2-7014-MH, E2-7020-MH, E2-7048-MH, E2-7050-MH, E2-7051-MH, E2-7057-MH, E2-7058-MH, E2-7059-MH, E2-7060-MH, E2-7061-MH, E2-7062-MH, E2-7063-MH, E2-7064-MH, E2-7065-MH, E2-7066-MH, E2-7067-MH, E2-7068-MH, E2-7069-CMH, E2-7070-MH, E2-7071-MH, E2-7072-MH, E2-7074-MH, E2-7075-MH, E2-7076-MH, E2-7077-CMH, E2-7078-MH, E2-7079-MH, E9-0008, E9-0025, E9-0031, E9-0035-G, E9-0037, E9-0050, E9-0083, E9-0085, E9-0086, E9-0088, E9-0089-G, E9-0090, E9-0091, E9-0092, E9-0093, E9-0094, E9-0095, E9-0098, E9-0099, E9-0100, E9-0101, E9-0102, E9-0103, E9-0108, E9-0109, E9-0110, E9-0111, E9-0112, E9-0113, E9-0114, E9-0115, E9-0116, E9-0118, E9-0119, E9-0120, E9-0121, E9-0122, E9-0123, E9-0124, E9-0125, E9-0126, E9-0127, E9-0128, E9-0129, E9-0129, E9-0130, E9-0139, E9-0141, E9-0142, E9-0143, E9-0144, E9-0145, E9-0146, E9-0147, E9-0148, E9-0149, E9-0150, E9-0151, E9-0152, E9-0153, E9-0155, E9-0157, E9-0158, E9-0159, E9-0162, E9-0163, E9-0164, E9-0165, E9-0166, E9-0169, E9-0170, E9-0171, E9-0172, E9-0173, E9-0177, E9-0178, E9-0179, E9-0180, E9-0181, E9-0183, E9-0184, E9-0185, E9-0188, E9-0249, E9-0253, ES-0005, ES-0006, ES-0007-C, ES-0022-CH, ES-0029-CH, ES-0034-G, ES-0056, ES-0069, ES-0071, ES-0072, ES-0076, ES-0078, ES-0084-G, ES-0086-G, ES-0087, ES-0088, ES-0089, ES-0090, ES-0091-H, ES-0092-CH, ES-0096, ES-0097, ES-0098, ES-0099-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0104, ES-0105, ES-0106, ES-0107, ES-0108, ES-0109, ES-0110, ES-0111, ES-0112, ES-0113, ES-0114, ES-0115, ES-0116, ES-0117, ES-0118, ES-0119, ES-0120, ES-0121, ES-0122, ES-0123, ES-0124, ES-0125, ES-0126, ES-0127, ES-0128, ES-0129, ES-0130, ES-0131-H, ES-0132, ES-0133, ES-0134, ES-0135, ES-0136, ES-0138, ES-0139, ES-0140, ES-0141, ES-0142, ES-0147, ES-0152, ES-0155-H, ES-0156, ES-0158, ES-0159, ES-0160, ES-0163-G, ES-0169-CH, ES-0170, ES-0171, ES-0172, ES-0176, ES-0178, ES-0180, ES-0181, ES-0182, ES-0184-CH, ES-0185-H, ES-0186-H, ES-0187-H, ES-0190-CH, ES-0191-H, ES-0192-H, ES-7010-CMH, ES-7015-MH, ES-7018-MH, ES-7021-MH, ES-7028-CMH, ES-7029-MH, ES-7030-CMH, ES-7031-CMH, ES-7033-CMH, ES-7034-CMH, ES-7035-CMH, ES-7036-CMH, ES-7037-CMH, ES-7039-MH.
Product Distributed Qty 845 units
Reason For Recall GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.

Event Detail

Event Id 62729
Product Type Devices
Status Terminated
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-04-26
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern Worldwide and Nationwide (USA) distribution.
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