Z-1709-2008

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

Name: Z-1709-2008 GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah
Creator: OEC Medical Systems, Inc
Published: 2008-07-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-07-02 / Terminated / root cause: manufacturing process

FDA source

OEC Medical Systems, Inc began a recall of GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah on 2008-07-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1709-2008
Status: Terminated
Initiated: 2008-07-02
Posted: 2008-09-20
Terminated: 2009-01-20
Recalling firm: GE Healthcare
Product: GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 660 units
Distribution: Nationwide Distribution including states of CA, FL, MS, and TX.
Product codes and lots: 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.

Product code JAA

K963952Class IISeries 9600 Mobile Digital Imaging SystemGe Dec Medical Systems / cleared 1996-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)