NRAC Issue #1656 ADDENDUM November 13, 2007 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ THE FOLLOWING IS AN UPDATE TO THE CLASS I RECALL WHICH APPEARED IN NATIONAL RECALL ALERT CENTERS WARNING ALERT ISSUE #1655 DATED 11-06-07 - PAGE 2 THE FOLLOWING IS A CLASS I RECALL. THERE IS A REASONABLE PROBABILITY THAT THE USE OF THE AFFECTED PRODUCT MAY CAUSE SERIOUS INJURY OR DEATH IF THE PROBLEM IS NOT CORRECTED. PRODUCT Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E, 970308E, 970309E, 970310E and 970311E RECALL NUMBER # Z-0129-2008 CODE Serial numbers of units affected: NA036960, NA036970, NA037000, NA037004, NA037005, NA037009, NA037010, NA037012, NA037014, NA037015, NA037020, NA037022, NA037025, NA037027, NA037029, NA037030, NA037030, NA037031, NA037032, NA037034, NA037035, NA037036, NA037044, NA037045, NA037046, NA037048, NA037050, NA037051, NA037052, NA037053, NA037056, NA037057, NA037058, NA037088, NA037090, NA037091, NA037092, NA037093, NA037094, NA037095, NA037097, NA037098, NA037108, NA037110, NA037111, NA037112, NA037114, NA037115, NA037116, NA037118, NA037119, NA037120, NA037121, NA037122, NA037123, NA037124, NA037125, NA037126, NA037127, NA037128, NA037129, NA037132, NA037134, NA037139, NA037140, NA037143, NA037145, NA037146, NA037147, NA037148, NA037149, NA037150, NA037154, NA037155, 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NA039760, NA039761, NA039762, NA039763, NA039764, NA039766, NA039767, NA039771, NA039772, NA039773, NA039774, NA039776, NA039778, NA039780, NA039781, NA039782, NA039784, NA039785, NA039786, NA039787, NA039790, NA039793, NA039795, NA039796, NA039797, NA039798, NA039799, NA039800, NA039802, NA039803, NA039804, NA039805, NA039806, NA039808, NA039809, NA039810, NA039814, NA039828, NA039839, NA039842, NA039843, NA039844, NA039846, NA039847, NA039848, NA039849, NA039850, NA039851, NA039852, NA039853, NA039854, NA039855, NA039856, NA039857, NA039858, NA039859, NA039860, NA039865, NA039866, NA039868, NA039871, NA039876, NA039877, NA039878 MANUFACTURED & RECALLED BY Welch Allyn Protocol, Inc, Beaverton, OR QUANTITY 1,795 units DISTRIBUTION Nationwide and Internationally REASON Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Mevatron KD2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 1940753 RECALL NUMBER # Z-0155-2008 PRODUCT b) Mevatron KD-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 8515520 and 9822685 RECALL NUMBER # Z-0156-2008 PRODUCT c) Mevatron KDS, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401522 RECALL NUMBER # Z-0157-2008 PRODUCT d) Mevatron KDS-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 9411588 and 9822693 RECALL NUMBER # Z-0158-2008 PRODUCT e) Mevatron-2 6300, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401316 RECALL NUMBER # Z-0159-2008 PRODUCT f) Mevatron M-2 6700, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401407 RECALL NUMBER # Z-0160-2008 PRODUCT g) Mevatron M-2 6740, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401506 RECALL NUMBER # Z-0161-2008 PRODUCT h) Mevatron MD-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401654 RECALL NUMBER # Z-0162-2008 PRODUCT i) Mevatron MDX-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401746 RECALL NUMBER # Z-0163-2008 PRODUCT j) Oncor Avant Garde, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5863472 RECALL NUMBER # Z-0164-2008 PRODUCT k) Oncor Expression, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 7360204 and 7360717 RECALL NUMBER # Z-0165-2008 PRODUCT l) Oncor Impression Plus, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5857912 RECALL NUMBER # Z-0166-2008 PRODUCT m) Oncor Impression, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5857920 RECALL NUMBER # Z-0167-2008 PRODUCT n) Mevatron M2/Primus Mid, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number 1940035 RECALL NUMBER # Z-0168-2008 PRODUCT o) Primus Plus, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 4504200 RECALL NUMBER # Z-0169-2008 CODE a) Serial numbers 2509, 2568, 2698, 2168, 2459, 2589, 2616, 2667, 1985, 2145, 2213, 2216, 2218, 2297, 2571, 2582, 2602, 2612, 2636, 2776, 2038, 2448, 2451, 2452, 2466, 2505, 2525, 2531, 2547, 2567, 2575, 2578, 2681, 2686, 2751, 2769, 2777, 2781, 2229, 2726, 2111, 2245, 2561, 1798, 2414, 2542, 2585, 2607, 2631, 2724, 2731, 2739, 2824, 2826, 2858, 2859, 2864, 2877, 2951, 2952, 3021, 3029, 3035, 3041, 2394, 2648, 2663, 2801, 2729, 2587, 2592, 02574A, 2498, 2621, 2704, 2494, 2601, 2807, 2327, 2405, 2569, 2353, 2754 b) Serial Numbers: 1633, 1772, 1874, 1901, 1938, 1941, 1944, 1987, 2014, 2076, 2082, 2088, 2135, 2154, 2173, 2175, 2179, 2228, 2246, 2273, 2315, 2329, 2348, 2383, 2508, 2562, 2568, 2579, 2586, 2598, 2614, 2634, 2645, 2646, 2656, 2676, 2679, 2713, 2743, 2756, 2202, 2462, 2436, 2472, 2474, 2652, 2133, 2224, 2319, 2099, 4, 5, 1894, 1928, 1948, 2043, 2074, 2128, 2131, 2376, 2431, 2437, 2441, 2444, 2496, 2584, 2595, 2687, 2711, 2721, 2757, 2774, 2558, 2726, 2111, 2115, 2457, 2714, 2065, 2413, 2414, 2542, 2577, 2585, 2606, 2623, 2631, 2724, 2725, 2727, 2732, 2739, 2775, 2786, 2824, 2826, 2858, 2859, 2864, 2481, 2563, 2609, 2617, 2638, 2639, 2643, 2649, 2659, 2672, 2697, 2734, 2742, 2771, 2811, 2837, 2885, 2561, 2715, 2718, 02587A, 02592A, 2498, 2621, 2537, 2601, 2422, 2483, 2541, 2624, 2123, 2282, 2327, 2405, 2405, 1953, 2662, 2479, 2569, 2127, 2345, 2754 c) Serial Numbers: 1917, 1988, 2019, 2232, 2104, 2069, 2193, 2194, 2221, 2159 d) Serial Numbers: 2055, 2097, 2106, 2108, 2122, 2183, 2208, 2222, 2242, 2244, 2251, 2263, 2269, 2272, 2276, 2284, 2289, 2324, 2335, 2336, 2339, 2357, 2358, 2372, 2513, 2514, 2518, 2665, 2691, 2108A, 2023, 2158, 2168, 2398, 2398BIS, 2264, 2084, 2447, 2453, 2553, AB4220323T, 2229, 2111, 2485, 2402, 2394, 2115, 2245, 2304, 2519, 2327, 2196, 2353 e) Serial Numbers: 2489, 2594, 2635, 2703, 2407, 24581968; f) Serial Numbers: 1966, 2029, 2223, 2488, 2787, 2408, 2651, 2752, 2239, 2429, 2861, 2849, 2219, 2432, 2464, 2664, 2418, 2428, 2708, 2779, 2619, 2704, 2802, 2749 g) Serial Numbers: 2011, 2093, 2156, 2161, 2171, 2177, 2186, 2211, 2227, 2247, 2254, 2271, 2325, 2338, 2343, 2349, 2355, 2367, 2369, 2523, 2526, 2758, 2767, 2435, 2591, 2164, 2267, 1969, 2484, 2389, 2301, 2417, 2442, 2581, 2608, 2629, 2632, 2633, 2693, 2741, 2821, 2331, 2723, 2456, 2468, 2533, 2766, 2841, 2889, 2907, 2939, 2943, 2654, 2684, 2503 h) Serial Numbers: 1949, 1991, 1996, 2045, 2053, 2067, 2113, 2117, 2139, 2152, 2189, 2192, 2199, 2231, 2233, 2234, 2235, 2238, 2241, 2252, 2261, 2281, 2316, 2328, 2374, 2397, M2166, 2283, 2305, 2346, 2427, 2487, 2605, 2674, 2682, 2683, 2856, 2539, 2445, 2588, 2661, 2812, 2937, 2163, 2478, 2205, 2884, 2362, 2392, 2425, 2426, 2454, 2502, 2535, 2546, 2599, 2615, 2637, 2657, 2685, 2691, 2461, 2262, 2423, 2528, 2641, 2694, 2716, 2761, 2813, 2819, 2825, 2874, 2714, 2217, 2249, 2544, 2118, 2439, 2709 i) Serial Numbers: 2125, 2137, 2538, 2499 j) Serial Numbers: 3738, 3817, 3904, 3905, 3926, 3934, 3938, 3987, 3988, 4016, 4079, 4082, 4095, 70-4077, 70-4113, 70-4188, 70-4197, 70-4283, 70-4368, 3852, 70-4168, 70-4169, 3737, 3739, 3758, 3806, 3856, 3884, 3891, 3912, 3929, 3937, 3941, 3944, 70-4163, 70-4291, 70-4325, 3895, 3896, 4049, 70-4201, 70-4297, 70-4314, 70-4184, 70-4213, 70-4223, 5012, 70-4311, 3881, 70-4324, 70-4217, 3932 k) Serial Numbers: 5029, 5037, 5042, 5094 l) Serial Numbers: 3753, 3754, 3755, 3761, 3764, 3769, 3778, 3783, 3791, 3793, 3801, 3802, 3803, 3804, 3815, 3846, 3855, 3877, 3888, 3901, 3907, 3945, 3948, 3953, 3955, 3957, 3964, 3975, 3981, 3989, 3998, 4015, 4019, 4035, 4065, 4067, 4072, 4091, 5033, 5060, 5088, 5093, 5096, 70-4119, 70-4122, 70-4129, 70-4135, 70-4142, 70-4144, 70-4145, 70-4157, 70-4159, 70-4161, 70-4166, 70-4172, 70-4174, 70-4175, 70-4177, 70-4183, 70-4222, 70-4262, 70-4306, 70-4317, 70-4343, 70-4345, 70-4349, 70-4354, 70-4356, 70-4362, 70-4378, 70-4379, 3956, 4011, 70-4136, 70-4154, 70-4334, 4024, 3796, 3799, 3865, 70-4361, 3795, 4074, 5002, 5034, 5057, 3739, 3808, 4017, 4022, 4068, 4081, 4084, 4096, 5001, 5011, 5032, 5053, 5058, 5086, 5087, 5095, 70-4107, 70-4132, 70-4147, 70-4149, 70-4153, 70-4171, 70-4189, 70-4288, 70-4312, 70-4331, 70-4333, 70-4366, 5031, 70-4158, 3983, 3823, 3965, 5061, 5091, 70-4124, 70-4137, 70-4329, 70-4348, 5068, 5085, 70-4215, 70-4253, 70-4272, 70-4305, 70-4335, 70-4338, 70-4123, 70-4176, 70-4209, 3816, 4012, 4053, 5023, 70-4186, 70-4241, 70-4244, 3776, 3848, 3858, 3963, 4002, 4027, 70-4097, 70-4346, 70-4384, 4071, 3836, 3827, 4005, 5039, 5040, 70-4231, 5030, 70-4328, 70-4365, 4026, 70-4258, 70-4301, 4009, 3916, 70-4278, 3925, 3954, 5027, 5044, 5069, 70-4224, 70-4295, 70-4299, 5004, 704093, 3968, 4037, 70-4193, 70-4292, 70-4127, 3841, 3863, 4008, 4062, 4064 m) Serial Numbers: 3878, 4021, 4078, 70-4143, 70-4207, 70-4235, 70-4257, 70-4344, 70-4296, 3974, 70-4165, 70-4167, 3729, 5022, 5035, 5074, 3811, 3845, 3962, 3973, 70-4152, 5015, 70-4238, 70-4374, 70-4386, 5024, 704083, 3894, 4048, 70-4276, 70-4277, 70-4281, 3883, 70-4083 n) Serial Numbers: 1966, 2011, 2029, 2046, 2156, 2171, 2177, 2186, 2247, 2261, 2506, 2507, 2512, 2515, 2516, 2517, 2521, 2522, 2524, 2526, 2527, 2532, 2572, 2573, 2593, 2596, 2611, 2613, 2622, 2626, 2644, 2647, 2669, 2678, 2689, 2692, 2695, 2696, 2699, 2702, 2705, 2722, 2735, 2738, 2745, 2758, 2765, 2767, 2784, 2791, 2792, 2794, 2806, 2814, 2816, 2817, 2818, 2834, 2845, 2847, 2855, 2857, 2875, 2898, 2901, 2906, 2913, 2921, 2929, 2955, 2959, 2961, 2962, 2965, 2968, 2974, 2988, 2995, 3009, 3013, 3016, 3018, 3045, 3055, 3057, 3061, 3071, 3078, 3082, 3084, 3089, 3101, 3103, 3116, 3118, 3126, 3133, 3136, 3138, 3147, 3156, 3162, 3192, 3207, 3208, 3228, 3232, 3243, 3258, 3274, 3285, 3287, 3294, 3296, 3298, 3303, 3304, 3316, 3353, 3364, 3383, 3397, 3409, 3425, 3433, 3434, 3435, 3439, 3448, 3458, 3482, 3495, 3503, 3512, 3517, 3541, 3557, 3576, 3591, 3604, 3605, 3616, 3617, 3618, 3623, 3624, 3629, 3631, 3639, 3644, 3664, 3673, 3678, 3692, 3699, 3702, 3736, 3748, 3756, 3774, 3788, 3798, 3805, 3826, 3842, 3859, 3873, 3931, 3939, 3986, 4018, 5092, 5500371, 70-4146, 70-4178, 70-4287, 70-4316, 70-4323, 70-4347, 70-4363, M2855, 3647, 4031, 59130, 3175, 3204, 3205, 3206, 3012, 3246, 3251, 3491, 3648, 2435, 70-4134, 2998, 3108, 3313, 2747, 2752, 2809, 2879, 2946, 3054, 3221, 3229, 3554, 3559, 3581, 3585, 3588, 3589, 3655, 3787, 3857, 3889, 3903, 3906, 3911, 3913, 3927, 5065, 70-4118, 70-4203, 70-4246, 2469, 2473, 2475, 2476, 2559, 2618, 3235, 3236, 3376, 4063, 70-4111, 2744, 3065, 3152, 3337, 2803, 2804, 2915, 3393, 3683, 4182, 4233, 1940035, 70-4182, 2861, 2603, 2969, 3301, 3575, 3625, 3627, 3676, 3882, 70-4202, 2086, 2257, 2295, 2352, 2401, 2438, 2576, 2604, 2707, 2759, 2778, 2835, 3051, 3063, 3169, 3321, 3394, 3914, 3923, 4092, 5048, 70-4284, 2005, 2057, 2443, 2465, 2543, 2545, 2552, 2597, 2625, 2642, 2653, 2673, 2675, 2688, 2706, 2719, 2737, 2748, 2795, 2822, 2831, 2876, 2881, 2926, 2932, 2935, 2947, 2953, 2971, 2984, 3001, 3015, 3056, 3059, 3062, 3086, 3088, 3096, 3099, 3141, 3197, 3253, 3314, 3328, 3363, 3415, 3652, 3792, 3885, 2949, 3358, 3385, 2868, 3449, 3451, 2566, 3712, 3847, 3946, 3951, 5016, 5025, 5082, 70-4269, 70-4319, 70-4339, 70-4369, 3609, 3789, 4248, 70-4248, 2698, 3775, 3777, 3779, 3784, 3807, 2583, 2677, 2799, 2852, 2981, 3281, 3355, 3432, 3478, 3537, 3538, 3555, 3593, 3633, 3643, 3705, 3726, 3733, 3743, 3785, 3869, 3898, 3928, 70-4151, 70-4273, ZTVL00009, ZTVX00003, 2299, 2362, 2392, 2402, 2425, 2426, 2454, 2455, 2471, 2495, 2497, 2529, 2535, 2546, 2599, 2637, 2657, 2685, 2691, 2712, 2728, 2736, 2772, 2843, 2853, 2873, 2925, 2999, 3035, 3038, 3073, 3083, 3166, 3167, 3178, 3185, 3195, 3196, 3198, 3252, 3275, 3282, 3325, 3335, 3338, 3341, 3344, 3357, 3379, 3429, 3442, 3472, 3476, 3508, 3523, 3527, 3528, 3532, 3535, 3548, 3563, 3637, 3674, 3685, 3694, 3723, 3741, 3747, 3821, 3838, 3854, 3871, 3874, 3875, 3886, 3892, 3933, 3971, 3982, 4007, 4014, 4023, 4025, 4038, 4073, 5009, 5018, 5019, 5051, 5054, 5055, 5070, 70-4104, 70-4106, 70-4108, 70-4114, 70-4115, 70-4138, 70-4191, 70-4261, 70-4375, 70-5005, 2255, 3834, 2886, 3194, 3052, 2534, 2789, 2982, 2983, 3368, 3388, 3463, 4087, 3006, 3132, 3139, 3164, 3173, 3188, 3263, 3266, 3277, 3293, 3306, 3331, 3352, 3404, 3419, 3437, 3446, 3447, 3473, 3505, 3509, 3546, 3596, 3607, 3613, 3615, 3635, 3656, 3658, 3665, 3671, 3681, 3687, 3697, 3715, 3716, 3771, 3809, 3843, 3849, 3851, 3864, 3866, 3879, 3908, 3918, 3921, 3935, 3966, 3992, 3997, 4003, 4034, 4041, 4044, 4046, 4052, 4058, 4066, 4069, 4094, 4236, 5071, 5072, 5078, 5080, 6100, 704088, 704098, 70-4121, 70-4128, 70-4155, 70-4164, 70-4196, 70-4199, 70-4211, 70-4214, 70-4216, 70-4228, 70-4242, 70-4243, 70-4245, 70-4259, 70-4263, 70-4265, 70-4274, 70-4286, 70-4293, 70-4294, 70-4298, 70-4303, 70-4307, 70-4321, 70-4332, 70-4337, 70-4342, 70-4352, 70-4353, 70-4355, 70-4358, 70-4371, 70-4372, 70-4377, 70-4381, 70-4382, 70-4383, 70-4385, 3309, 3682, 340563, 722348, 70-4268, 3381, 2382, 3812, 2549, 2554, 2717, 2888, 70-4229, 3659, 70-4289, 2499, 2619, 2684, 2704, 2802, 3247 o) Serial Numbers: 2701, 2733, 2762, 2768, 2823, 2827, 2828, 2836, 2839, 2842, 2846, 2848, 2863, 2867, 2887, 2893, 2894, 2896, 2899, 2911, 2912, 2914, 2931, 2933, 2934, 2936, 2941, 2954, 2958, 2972, 2991, 2996, 2997, 3004, 3014, 3019, 3025, 3027, 3039, 3049, 3053, 3066, 3068, 3069, 3075, 3076, 3077, 3079, 3087, 3092, 3097, 3102, 3105, 3109, 3111, 3112, 3114, 3125, 3131, 3134, 3137, 3142, 3153, 3154, 3161, 3165, 3168, 3174, 3179, 3181, 3186, 3203, 3209, 3211, 3212, 3213, 3214, 3215, 3223, 3224, 3225, 3239, 3241, 3244, 3245, 3254, 3255, 3257, 3261, 3264, 3267, 3272, 3286, 3292, 3297, 3302, 3305, 3318, 3319, 3323, 3324, 3342, 3349, 3354, 3361, 3365, 3367, 3377, 3392, 3402, 3403, 3413, 3414, 3417, 3418, 3422, 3423, 3424, 3426, 3427, 3443, 3452, 3453, 3456, 3461, 3471, 3474, 3477, 3479, 3484, 3501, 3504, 3514, 3515, 3516, 3519, 3524, 3533, 3534, 3542, 3547, 3564, 3565, 3568, 3569, 3572, 3574, 3583, 3595, 3597, 3601, 3602, 3622, 3634, 3651, 3657, 3666, 3667, 3672, 3675, 3679, 3695, 3696, 3701, 3709, 3711, 3731, 3745, 3751, 3773, 3781, 3825, 3829, 3832, 3835, 3862, 3899, 3922, 3924, 3942, 3949, 3978, 3979, 4001, 4036, 4059, 5008, 50941, 2933A, 70-4117, 70-4185, 3744, 3749, 340258, 340262, 2956, 2963, 3579, 3582, 3587, 3592, 3663, 2773, 2815, 2964, 3046, 3217, 3308, 3334, 3724, 3917, 3598, 3752, 3373, 3561, 104744, 3042, 3158, 3191, 3284, 3291, 3295, 3356, 3378, 3382, 3406, 3407, 3469, 3619, 3638, 3641, 3645, 3742, 3919, 70-4173, 3612, 3824, 3995, 3732, 2869, 3219, 3343, 3502, 3861, 2871, 3268, 70-4126, 2753, 2808, 2928, 2987, 3026, 3032, 3037, 3047, 3117, 3201, 3234, 3346, 3398, 3431, 3522, 3545, 3599, 3649, 3703, 3704, 3767, 3814, 5063, 2782, 2783, 2796, 2829, 2832, 2833, 2851, 2854, 2866, 2891, 2938, 2942, 2944, 2945, 2948, 2967, 2973, 2989, 2994, 3031, 3033, 3034, 3044, 3072, 3081, 3091, 3093, 3094, 3098, 3106, 3127, 3128, 3129, 3144, 3145, 3155, 3182, 3199, 3231, 3259, 3332, 3333, 3348, 3351, 3362, 3387, 3399, 3438, 3467, 3539, 3549, 3552, 3578, 3614, 3686, 3693, 3763, 4013, 2957, 3307, 3395, 3444, 3936, 2862, 2976, 3642, 3833, 4099, 4131, 4232, 70-4131, 70-4308, 2793, 2805, 2918, 3202, 3499, 3571, 3577, 3684, 3714, 3718, 3725, 3768, 3786, 3794, 3958, 3972, 3977, 3999, 4042, 4075, 5073, 98943, 102842, 340274, 70-4264, 70-4194, 3311, 3369, 3401, 2785, 2992, 3107, 3135, 3183, 3326, 3372, 3396, 3408, 3416, 3421, 3475, 3689, 3961, 4039, 5036, 70-4133, 70-4271, ZTVK00010, 104, 2844, 2908, 3022, 3058, 3143, 3148, 3157, 3184, 3187, 3189, 3193, 3233, 3237, 3256, 3262, 3278, 3315, 3327, 3336, 3359, 3366, 3436, 3488, 3513, 3518, 3521, 3526, 3529, 3531, 3536, 3668, 3677, 3717, 3813, 3819, 3822, 3839, 3844, 3867, 3868, 3872, 3876, 3902, 3943, 3984, 3985, 3991, 4033, 4043, 4047, 4055, 4057, 4085, 4105, 5007, 5010, 5021, 5050, 5066, 5079, 5090, 70-4101, 70-4102, 70-4187, 70-4204, 70-4206, 70-4219, 70-4225, 70-4227, 70-4247, 70-4252, 70-4266, 70-4275, 70-4351, 70-4357, 70-4364, 3250, 4103, 70-4103, 3288, 2975, 3227, 3339, 3347, 3386, 3389, 3994, 4045, 70-4373, 3028, 3722, 4061, 70-4195, 344125, 2985, 3011, 3483, 3506, 3562, 3698, 3412, 3002, 3273, 3276, 3489, 3492, 2916, 2917, 2922, 2978, 2979, 3005, 3007, 3067, 3085, 3115, 3119, 3149, 3176, 3248, 3265, 3299, 3455, 3459, 3462, 3464, 3468, 3511, 3558, 3573, 3586, 3632, 3646, 3669, 3762, 3766, 3782, 3818, 3831, 3853, 3915, 3947, 3959, 3976, 3993, 4051, 4076, 4239, 5047, 340203, 70-4116, 70-4156, 70-4162, 70-4198, 70-4205, 70-4208, 70-4212, 70-4237, 70-4255, 70-4279, 70-4315, 70-4318, 70-4322, 70-4326, 70-4341, 70-4376, 3043, 3594, 340180, 3746, 340263, 3384, 3146, 3283, 70-4282, 2897, 2902, 2904, 2993, 3249, 3626, 3628, 3893, 4004, 3727, 3728, 3441, 70-4327, 2905, 3121, 3123, 3177, 3216, 3584, 3757, 3828, 3312, 3317, 2882, 3279, 3734, 4218, 70-4218, 2924, 3024, 3606, 3608, 3909, 70-4139, 70-4141, 70-4251, 2797, 2883, 2903, 2919, 2923, 2986, 3036, 3095, 3122, 3159, 3172, 3242, 3391, 3454, 3466, 3543, 3553, 3556, 3621, 3636, 3653, 3654, 3661, 3662, 3713, 3772, 3967, 3969, 4006, 4028, 4109, 5045, 5046, 70-4112, 70-4192, 70-4285, 2878, 3017, 3329, 2872, 2966, 3064, 3797, 3897, 5013, 2892, 3008, 3074, 3218, 3226, 3375, 3486, 3567, 3493, 3003, 3507, 3735, 3759, 4086, 5003, 340264, 70-4256, 3113, 3238, 3405, 3465, 3481, 3691, 3706, 3708, 3719, 3721, 340251, 298700097, 302600003, 303200005, 303700007, 304700009, 311700023, 334600031, 3411, 3887, 3525, 3544, 70-4302. MANUFACTURED & RECALLED BY Siemens Medical Solutions USA, Inc., Concord, CA QUANTITY 2,123 units DISTRIBUTION Nationwide and Internationally REASON Mistreatment of radiation therapy due to inadvertent parameter changes or miscalibration in Service Mode. The miscalibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode." --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Foundation(r) Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0082-2008 PRODUCT b) Foundation(r) Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0083-2008 PRODUCT c) Foundation(r) Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0084-2008 PRODUCT d) Foundation(r) Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0085-2008 PRODUCT e) Foundation(r) Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0086-2008 PRODUCT f) Foundation(r) Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0087-2008 PRODUCT g) Foundation(r) Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0088-2008 PRODUCT h) Foundation(r) Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0089-2008 PRODUCT i) Foundation(r) Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0090-2008 PRODUCT j) Foundation(r) Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0091-2008 PRODUCT k) Foundation(r) Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0092-2008 PRODUCT l) Foundation(r) Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0093-2008 PRODUCT m) Foundation(r) Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0094-2008 PRODUCT n) Foundation(r) Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0095-2008 PRODUCT o) Foundation(r) Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0096-2008 PRODUCT p) Foundation(r) Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0097-2008 PRODUCT q) Foundation(r) Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0098-2008 PRODUCT r) Foundation(r) Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant RECALL NUMBER # Z-0099-2008 CODE a) Lot #: 633811, 633851, 738381, 738391, 770021, 777371, 792441, 817581, 831031, 878311, 905531, 905541, 907051, 944231, and 949371 b) Lot #: 602661, 691241, 633821, 633861, 738401, 770031, 777381, 792451, 797031, 811141, 831041, 836151, 845221, 848651, 857671, 878321, 905551, 932691, 949381, 958921 and 964161 c) Lot #: 644021, 648331, 672341, 675901, 678461, 678471, 678481, 678491, 678501, 678511, 678521, 693251, 694501, 697771, 732831, 733871, 736411, 736741, 738071, 738081, 738411, 738421, 770041, 774781, 774791, 777391, 779571, 779581, 783901, 783911, 788351, 794371, 794381, 811151, 811161, 835501, 835511, 836161, 844591, 845951, 848661, 854461, 854471, 854481, 854491, 857681, 874941, 874951, 882561, 882571, 882581, 893551, 893561, 893571, 903121, 903131, 933751, 944241, 944251, 949391, 949401, 964171, 964181, 964191 and 964201 d) Lot #: 679631, 678531, 678541, 678551, 678561, 678571, 691661, 692771, 692761, 694351, 694401, 694411, 694421, 698261, 695131, 695911, 697781, 730131, 731451, 731461, 731471, 205452, 736421, 770051, 770061, 770071, 770181, 780151, 783921, 788361, 792671, 794391, 811171, 811181, 811191, 811201, 811291, 832281, 832291, 835521, 842301, 842311, 848671, 854501, 854511 854981, 874961, 874971, 874981, 882591, 882601, 893581, 893591, 893601, 893611, 903141, 903151, 905561, 925731, 925741, 925751, 927231, 932711, 932721, 933761, 933771, 933781, 944261, 944271, 949411, 949421, 964211, 964221, 964231 and 964241 e) Lot #: 640791, 640801, 640811, 677101, 677111, 678581, 678591, 678601, 678611, 678621, 679611, 679621, 693841, 693851, 693861, 695121, 695861, 697851, 697861, 698771, 730141, 730221, 731481, 003612, 003622, 003632, 003642, 208672, 735781, 736431, 736441, 736451, 736461, 736751, 737391, 738431, 738891, 738911, 770081, 770191, 772371, 776721, 778421, 780161, 783931, 788381, 788391, 794401, 795481, 795491, 812181, 812191, 812201, 812211, 813511, 817551, 817561, 833181, 833191, 834981, 834991, 837691, 837791, 842321, 842331, 847351, 847361, 847391, 847401, 854341, 854381, 854391, 854401, 854411, 857691, 857701, 874991, 875001, 878331, 878351, 878531, 878541, 882611, 882621, 882631, 891271, 891281, 891301, 893631, 893641, 905571, 905581, 907081, 907091, 907101, 907111, 925761, 925771, 932731, 932741, 938211, 938221, 949431, 949441, 951081, 964251, 964261, 964271, 964281, 964291, 964301, 964311 and 421494A f) Lot #: 629071, 677121, 677131, 678651, 678661, 678671, 678681, 679641, 691251, 691261, 691271, 693871, 693881, 694511, 694521, 694531, 695111, 697791, 698971, 698981, 730201, 731491, 733951, 734531, 736471, 736481, 736761, 738091, 738101, 738901, 770091, 772351, 772361, 777411, 780171, 783941, 788411, 788421, 795501, 795511, 812221, 813521, 813531, 814301, 814311, 817571, 834021, 834031, 835551, 836171, 842341, 842351, 845961, 847381, 854351, 854421, 854431, 854441, 855871, 855881, 857721, 875011, 875021, 878341, 878361, 878551, 878561, 891291, 891311, 893621, 894391, 894401, 905591, 905601, 907061, 907071, 925781, 925791, 932751, 938231, 938241, 938251, 949451, 949461, 951091, 959761, 959771, 964321, 964331, 964341 and 964351 g) Lot #: 644031, 672331, 677061, 677981, 677991, 678691, 678701, 678711, 678721, 679651, 679661, 697671, 691281, 691291, 693261, 699171, 730241, 735791, 736491, 736501, 736511, 736771, 737811, 738441, 738451, 738461, 770101, 770111, 770221, 773281, 777421, 778431, 782551, 788441, 788451, 810911, 811211, 813501, 830751, 830761, 830911, 830921, 835531, 835541, 842361, 842371, 847411, 848681, 848691, 853541, 857731, 857741, 857751, 875571, 875581, 878371, 878381, 878391, 885381, 885401, 892331, 894241, 894251, 905611, 907121, 907131, 907141, 907211, 925801, 925811, 927241, 927251, 927261, 932761, 949471, 949491, 949851, 951101, 951111, 951121, 958941, 966131, 966141 and 982721 h) Lot #: 602731, 677071, 677081, 677091, 678001, 678011, 678731, 678741, 678751, 678761, 693891, 693901, 695101, 697801, 699141, 699151, 732841, 208522, 208532, 208542, 208552, 733961, 734521, 735721, 736521, 739121, 770121, 777431, 780391, 783951, 788491, 796481, 797041, 797341, 814321, 814331, 830931, 830941, 835561, 836181, 842381, 844601, 848701, 853551, 855191, 855201, 857761, 857771, 875591, 875601, 878401, 878411, 878421, 878431, 885391, 892341, 907151, 907161, 907171, 907181, 907191, 907201, 925821, 933801, 933811, 933821, 933831, 949501, 949511, 964361, 964371, 982731 and 421511A i) Lot #: 546541, 675911, 677601, 678771, 678781, 693911, 693921, 695081, 697091, 697811, 699931, 730251, 732541, 732851, 735731, 736531, 736781, 739441, 770131, 777441, 777451, 781061, 783961, 788501, 788511, 794411, 794421, 797051, 830291, 830301, 830951, 835571, 835581, 842391, 842401, 844611, 854991, 857781, 872031, 872041, 872051, 872061, 878571, 878581, 885411, 885421, 892351, 892361, 892371, 892381, 905621, 905881, 907221, 933841, 933851, 933861, 938261, 939751, 944281, 944291, 964381, 964391, 964401, 982741 and 421521A j) Lot #: 624391, 675921, 678791, 678801, 678811, 678821, 679691, 691671, 693931, 693941, 695061, 695921, 696971, 697101, 699941, 208562, 208582, 732861, 733821, 733841, 734401, 735741, 736541, 770141, 773291, 773301, 777461, 779901, 783971, 788521, 794431, 797061, 830311, 831511, 835591, 835601, 842411, 842421, 857791, 872071, 882641, 892391, 892401, 905891, 905901, 907231, 933871, 938271, 958951, 964411, 964421 and 421531A k) Lot #: 624401, 676821, 677141, 677611, 678831, 678841, 678851, 678861, 678871, 695171, 633831, 733831, 734561, 738471, 738481, 738491, 770151, 777471, 778441, 778451, 788531, 788541, 814371, 830961, 840341, 840351, 840361, 844621, 854641, 854651, 855001, 857801, 894261, 894271, 905631, 905641, 905651, 907241, 933881, 933891, 949521, 949531, 958961, 964431, 964441 and 964451 l) Lot #: 542491, 624411, 676831, 678881, 678891, 679701, 690791, 695161, 695931, 735751, 770161, 777481, 777491, 788551, 794441, 814361, 830971, 844631, 844641, 847421, 850801, 854661, 854671, 875521, 875531, 878441, 882651, 882661, 894281, 894291, 905661, 907251, 933901, 949551 and 964471 m) Lot #: 624421, 676851, 676861, 677151, 678901, 678911, 678921, 693271, 695151, 738501, 739461, 770171, 777501, 777511, 781071, 788561, 794451, 814351, 830981, 830991, 855011, 875541, 878451, 894301, 894311, 894321, 907261, 933911, 949561 and 949571 n) Lot #: 676841, 678931, 678941, 679711, 690801, 695141, 695941, 777521, 781081, 788571, 814341, 831001, 844641, 854681, 855021, 878591, 894331, 894341, 894351, 907271, 933921, 933931, 949581, 949591, 964481, 964491 and 519861A o) Lot #: 608031, 648321, 675931, 678951, 678961, 678971, 695091, 695851, 780401, 788581, 788591, 788601, 794461, 831021, 840371, 844651, 848711, 855031, 857811, 875551, 894361, 894371, 907281, 933941, 949601, 964501 and 964511 p) Lot #: 627751, 629111, 678981, 678991, 679001, 690231, 210192, 695841, 855041, 875561, 882671, 894381, 905671, 9072291, 939741, 949611 and 964521 q) Lot #: 546711, 546721, 546731, 679011, 679021, 379031, 679041, 679051, 695071, 695871 and 989981 r) Lot #: 677621, 679061, 679071, 679081, 679091, 633841, 695881, 899041 and 989991 MANUFACTURED & RECALLED BY Encore Medical, LP, Austin, TX QUANTITY 5,191 units DISTRIBUTION Nationwide and Internationally REASON Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions RECALL NUMBER # Z-0113-2008 CODE Serial Numbers: D00210, D00223, D00225, D00239, D00241, D00293, D00326, D00347, D00415, D00425, D00435, D00445, D00455, D00456, D00459, D00460, D00465, D00467, D00468, D00469, D00480, D00481, D00484, D00485, D00487, D00490, D00491, D00493, D00495, D00502, D00503, D00505, D00512, D00516, D00517, D00523, D00525, D00531, D00532, D00537, D00539, D00541, D00542, D00543, D00546, D00548, D00550, D00551, D00552, D00554, D00558, D00560, D00561, D00562, D00563, D00564, D00565, D00566, D00567, D00568, D00569, D00570, D00571, D00572, D00573, D00574, D00575, D00576, D00577, D00579, D00580, D00581, D00582, D00625, D00627, D00628, D00632, D00633, D00636, D00638, D00639, D00640, D00649, D00652, D00653, D00655, D00665, D00666, D00668, D00108, D00123, D00134, D00139, D00168, D00173, D00176, D00178, D00182, D00185, D00186, D00187, D00189, D00192, D00193, D00194, D00195, D00198, D00199, D00200, D00203, D00209, D00214, D00220, D00224, D00226, D00227, D00228, D00230, D00231, D00232, D00233, D00236, D00242, D00243, D00244, D00246, D00249, D00252, D00254, D00258, D00282, D00291, D00292, D00295, D00296, D00297, D00299, D00300, D00302, D00303, D00304, D00305, D00306, D00307, D00310, D00312, D00314, D00316, D00317, D00318, D00319, D00327, D00330, D00335, D00336, D00337, D00339, D00340, D00343, D00344, D00346, D00349, D00350, D00351, D00352, D00354, D00355, D00356, D00359, D00361, D00362, D00364, D00366, D00367, D00372, D00374, D00375, D00388, D00391, D00392, D00393, D00395, D00396, D00397, D00398, D00399, D00402, D00403, D00404, D00405, D00406, D00411, D00413, D00418, D00420, D00421, D00422, D00423, D00426, D00451, D00180, D00379, D00387, D00430, D00433, D00444, D00454, D00464, D00470, D00476, D00497, D00509, D00513, D00522, D00526, D00540, D00544, D00545, D00547, D00549, D00553, D00555, D00556, D00557, D00559, D00585, D00586, D00103, D00155, D00166, D00250, D00251, D00255, D00325, D00331, D00595, D00584, D00280, D00342, D00369, D00148, D00213, D00301, D00428, D00601, D00602, D00603, D00604, D00324, D00151, D00471, D00519, D00593, D00466, D00494, D00659, D00432, D00473, D00321, D00591, D00599, D00153, D00217, D00222, D00248, D00437, D00514, D00322, D00449, D00474, D00475, D00478, D00504, D00507, D00508, D00521, D00528, D00529, D00533, D00534, D00583, D00634, D00635, D00641, D00644, D00645, D00663, D00126, D00128, D00240, D00272, D00277, D00279, D00332, D00341, D00407, D00419, D00486, D00424, D00499, D00288, D00308, D00394, D00483, D00143, D00117, D00138, D00150, D00165, D00167, D00183, D00218, D00245, D00253, D00259, D00261, D00264, D00315, D00328, D00378, D00383, D00385, D00431, D00462, D00613, D00618, D00121, D00141, D00154, D00170, D00171, D00190, D00234, D00256, D00267, D00311, D00313, D00461, D00145, D00146, D00196, D00201, D00205, D00206, D00207, D00257, D00263, D00266, D00268, D00410, D00438, D00439, D00458, D00479, D00488, D00489, D00496, D00511, D00518, D00520, D00527, D00538, D00594, D00596, D00598, D00600, D00605, D00621, D00660, D00661, D00179, D00202, D00204, D00208, D00215, D00219, D00221, D00237, D00260, D00265, D00271, D00275, D00276, D00281, D00285, D00286, D00287, D00353, D00358, D00360, D00365, D00429, D00309, D00334, D00368, D00477, D00482, D00149, D00152, D00289, D00290, D00323, D00401, D00211, D00144, D00181, D00191, D00269, D00472, D00588, D00589, D00161, D00162, D00164, D00229, D00329, D00370, D00371, D00390, D00427, D00160, D00212, D00283, D00320, D00122, D00137, D00156, D00377, D00409, D00434, D00446, D00447, D00450, D00452, D00453, D00463, D00492, D00506, D00510, D00515, D00524, D00530, D00535, D00578, D00587, D00590, D00592, D00597, D00606, D00607, D00608, D00609, D00610, D00611, D00612, D00614, D00615, D00616, D00617, D00619, D00620, D00622, D00623, D00624, D00626, D00629, D00630, D00631, D00642, D00643, D00647, D00650, D00651, D00654, D00656, D00658, D00662, D00664, D00667, D00669, D00670, D00672, D00101, D00105, D00107, D00113, D00125, D00127, D00131, D00132, D00135, D00136, D00158, D00163, D00175, D00188, D00278, D00294, D00333, D00357, D00373, D00376, D00381, D00382, D00384, D00386, D00389, D00400, D00408, D00412, D00414, D00416, D00417, D00436, D00440, D00441, D00442, D00443, D00498, D00500, D00501. Version 6.2.0 was distributed 3/24/07 and version 6.2.1: 4/10/07 MANUFACTURER GE Medical Systems, Kretztechnik GmbH & Co. OHG, Zipf, Austria RECALLED BY GE Healthcare, Wauwatosa, WI QUANTITY 521 units DISTRIBUTION Nationwide REASON When a spectrum of a Pulsed Wave Doppler showing an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities. ---------------------------------------------------------------------------