Recall of GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62729
  • Event Risk Class
    Class 2
  • Event Number
    Z-2241-2012
  • Event Initiated Date
    2010-04-26
  • Event Date Posted
    2012-08-22
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-08-22
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • Reason
    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.
  • Action
    No customer communication took place. On April 26, 2010, GE began opening service cases for field engineers to begin replacing the snubber boards. This action has been completed as of October 29, 2010.

Device

  • Model / Serial
    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 Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide and Nationwide (USA) distribution.
  • 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA