Class 2 Device Recall Mobile Fluoroscopy System

• Date Initiated by Firm: July 02, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on January 20, 2009
• Recall Number: Z-1709-2008
• Recall Event ID: 49483
• 510(K)Number: K963952
• Product Classification: Image-intensified fluoroscopic x-ray system. - Product Code JAA
• Product: GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
• Code Information: 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.
• Recalling Firm/ Manufacturer: OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: 412-477-7432
• Manufacturer 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
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAA and Original Applicant = GE DEC MEDICAL SYSTEMS