GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes recall
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…
Why was GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- GE OEC Medical Systems, Inc
- Quantity
- 845 units
- Distribution
- Worldwide and Nationwide (USA) distribution.
- Recall date
- August 29, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)