OEC Medical Systems, Inc: GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.

Recall number

Z-1709-2008

Recalling firm

OEC Medical Systems, Inc

Product

GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.

Status

Terminated

Initiated

2008-07-02

Posted

2008-09-20

Terminated

2009-01-20

Reason

Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE

Root cause

Equipment maintenance

Action

Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded.

Quantity

660 units

Distribution

Nationwide Distribution including states of CA, FL, MS, and TX.

Lot, serial or model codes

Serial numbers: 69-1484, 69-3633, 69-3707, 69-1266-RC, 6C-0009-S, 62-0134, 69-1332, 69-3582, 69-3324, 69-2816, 62-0117, 69-2154, 65-0221, 69-2620, 69-2556, 69-0150, 69-3741, 62-0082, 62-0367, 62-0110-RC, 69-2574, 69-0313, 69-3774, 69-0108, 69-2878, 69-0195, 69-0028, 69-3580, 62-0473, 69-2035, 69-2881, 69-2775, 69-2234, 62-0261, 6S-0093-C, 69-2639-C, 69-2615, 69-2882, 62-0154, 69-1075, 69-1440, 6S-0044, 69-0357, 69-3130, 69-2699, 69-3876, 62-0086, 69-2716, 6S-0213, 69-2891, 62-0222, 69-2046, 69-2127, 69-2297, 69-2760, 69-2999-RC1, 69-3245, 6S-0137-C, 6S-0051C, 69-1022, 69-3026, 62-0087, 6S-0079-C, 69-0343, 62-0159, 69-0216, 62-0611, 69-2904, 69-3875, 69-3769, 6S-0199, 69-2767, 69-1087, 69-1401, 62-0239, 69-3519, 69-2592, 69-0282, 69-3776, 69-0436, 69-3145, 69-2320, 69-3577, 69-2621, 69-2553, 69-1188-RC, 69-0082, 6S-0228, 69-3833, 69-1009, 69-3668, 6S-0233, 69-0397, 69-2884, 69-1341, 69-0429, 69-3157, 69-0041, 69-3486, 69-1040, 69-2642, 62-0203, 69-3808, 69-0432, 69-3792, 62-0132, 62-0350, 69-2814, 65-0087-C, 6S-0086-C, 6S-0170, 66-0046, 69-0482, 69-2983, 69-335C, 69-2542, 69-2436-RC, 69-2634, 69-2879, 69-3866, 62-0481-C, 62-0600, 69-2916, 69-3368, 69-0304, 69-2781, 69-3409, 69-0243, 69-3258, 62-0100, 69-1348, 69-2222, 69-2126, 69-2293, 69-3512, 69-3888, 69-2545, 69-0094, 69-2873, 69-2870, 69-2874, 6S-0251, 69-3467-C, 69-2702, 69-1391, 69-3811, 6S-0156, 6S-0063, 69-1461, 69-3260, 69-3716, 69-3084, 69-2539, 69-3907, 62-0127, 6C-0042-RF, 69-3113, 69-3766, 69-0479, 62-0365, 69-2227, 69-3835-RC, 69-0066, 6S-0283, 69-1306, 69-2562, 69-1001, 69-1437, 69-3202, 69-0119, 69-2617, 6C-0017-RC, 69-1020, 69-2263, 69-0086, 69-3397, 62-0347, 69-0042, 62-0429, 69-3476, 69-0452, 69-0382, 6C-0015, 62-0126, 62-0596, 69-1454, 69-0360-RC, 69-2913, 69-1416, 69-2567, 69-2675, 62-0051, 69-2885, 6S-0197, 69-2268, 69-2269, 69-0068, 69-3232, 69-2348, 69-3312, 69-2611-C, 69-2591, 69-3837, 69-3618, 69-0130, 69-2405, 62-0604, 69-2828, 69-0289, 69-3740, 69-1227, 69-2968, 69-0135, 69-2654-C, 69-2941, 69-2142, 62-0054, 69-3705, 6S-0217, 69-1189, 69-2271, 69-0093, 6S-0301, 69-2521, 69-0205-RC, 69-2706, 69-3481, 69-2031, 62-0223, 69-1280, 69-1427-RC, 69-2773-RC, 6S-0128, 69-2725, 69-3804, 69-1472-RC, 69-0098, 69-3162, 69-0156, 62-0468, 69-3899, 69-2684, 69-0414, 69-1508, 69-0283, 69-2299-RC, 69-2079, 69-3654, 69-1413, 69-2285, 62-0560, 69-0183, 69-1027-RM, 62-0337, 69-0026, 69-3755, 69-3856, 69-2748, 69-2746, 65-0297, 69-3821, 69-2533, 69-3585, 69-3564, 69-2756, 69-0021, 69-2616, 69-1411, 69-0384, 69-3191, 69-3639-RC, 69-1011, 69-3807, 69-3470, 69-1173, 69-3253, 69-3541, 69-2623, 69-2625-C, 69-2758, 62-0073, 69-0081, 6S-0208, 6S-0209-C, 69-0020, 69-1486, 69-3640, 6S-0141, 69-2061-RC, 6S-0144, 69-3719, 69-2479, 69-3361, 69-2792, 62-0274, 69-2368, 69-2059, 69-2963-RC, 6S-0161-C, 69-1324, 69-1433, 69-2548, 69-3438, 62-0155, 62-0377, 6S-0184-C, 62-0016, 69-2589, 62-0340, 62-0040, 6S-0101-C, 69-2194, 69-2024, 69-3077, 69-0427, 69-3190, 69-0097, 69-2581, 69-2550, 69-3608, 6S-0114, 69-0402, 62-0081, 69-1405, 6S-0250, 69-3032, 69-1449, 69-2583, 69-2544, 69-1383, 6S,0106, 69-2053, 6S-0050, 69-2391, 69-3878, 69-0474, 69-3902, 69-1404, 69-2943, 69-0060, 6S-0055-C-RC, 62-0092, 69-2549, 62-0441, 62-0161, 69-3223, 69-3212, 69-1006, 62-0108, 69-3471, 6S-0256, 69-1496, 69-2025, 6S-0004, 69-3686, 69-3388, 69-1032, 69-3053, 69-3441, 62-0068, 69-1386, 69-3905, 69-2596-C, 69-2338, 69-2115, 69-0337, 69-2034, 69-2686, 69-3429, 69-2764, 62-0385, 69-3777-RC, 69-3088, 69-2701, 69-3767, 62-0474, 69-2692, 69-2555, 6S-0002, 6S-0133, 69-0234, 69-2375, 6C-0004, 69-0100, 69-3612, 69-0172, 69-3183, 69-2597-C, 69-0027, 69-1264, 62-0076, 6C-0005, 69-2441, 62-0047, 62-0136, 69-1334, 69-2413, 69-3198, 69-3259, 69-2323, 69-1392, 69-3657, 69-3825, 69-1441, 62-0085, 69-2033, 62-0578, 69-2653-C, 69-0386, 62-0069, 69-2783, 69-1381, 6S-0131, 62-0160, 69-3841, 69-2543, 69-2485, 69-1477, 69-2278, 69-3242, 69-0069, 69-2827-RC, 69-3733-RC, 69-2203, 69-0087, 62-0518, 69-1473, 69-3854, 69-1042, 69-0101, 69-0139, 69-0155, 69-0453, 6S-0132, 69-2613, 69-2851, 6S-0181, 6S-0082-C, 62-0496, 69-1390, 69-3892, 69-3166, 69-2063, 69-3020, 6S-0061-RC, 6C-0023-RC, and 6S-0187.

510(k) numbers

["K963952"]

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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