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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62729

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 26, 2010
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE OEC Medical Systems, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2241-2012
Recall number
Z-2241-2012
Initiated
April 26, 2010
Classification
Class II
Status
Terminated
Quantity
845 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Worldwide and Nationwide (USA) distribution.