Philips Zenition 70, Model Number: 718133
FDA Device Recall #Z-0353-2025 — Class II — October 7, 2024
Recall Summary
| Recall Number | Z-0353-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 7, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best, N/A |
| Product Type | Devices |
| Quantity | 2,247 units (582 US, 84 Canada, 1,581 R.O.W.) |
Product Description
Philips Zenition 70, Model Number: 718133
Reason for Recall
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lao People's Democratic Republic, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, R¿union, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, Yemen.
Lot / Code Information
Model Number: 718133; UDI-DI: (01)00884838091528(21); Serial Numbers: 420, 4093, 2851, 3947, 2571, 4211, 3325, 3326, 2324, 3665, 491, 480, 579, 580, 581, 582, 4138, 71, 3657, 3660, 3889, 669, 670, 671, 233, 3416, 4351, 4352, 4353, 4355, 3971, 3972, 4387, 4278, 2880, 3366, 4062, 4063, 3374, 4201, 4083, 1290, 3894, 932, 933, 4309, 1796, 3355, 3680, 4156, 562, 1983, 4206, 3395, 1310, 3758, 63, 1787, 2888, 684, 235, 557, 4014, 2056, 3658, 3661, 1801, 108, 109, 3354, 572, 1901, 4431, 1086, 1868, 1899, 1758, 2081, 4223, 626, 652, 654, 655, 829, 1786, 2957, 3800, 1904, 3393, 4155, 4302, 3523, 4170, 4432, 651, 85, 4013, 3973, 1902, 563, 2202, 1903, 4386, 234, 2720, 202, 553, 3686, 822, 672, 3631, 72, 3892, 3893, 3895, 3896, 4176, 3491, 2958, 1219, 3392, 653, 1195, 1900, 4147, 2938, 1072, 101, 103, 2106, 1569, 3394, 1848, 1852, 4020, 4186, 3604, 106, 4096, 561, 1802, 4094, 3348, 1837, 944, 1192, 1625, 1194, 4396, 4279, 4280, 3683, 1944, 3940, 2887, 1204, 62, 1536, 1212, 20, 52, 1675, 2380, 2381, 2681, 2276, 2342, 1525, 1224, 2105, 3385, 3459, 1581, 2680, 4111, 2172, 3583, 1599, 1945, 4252, 1451, 4167, 4171, 3133, 3135, 3585, 3933, 3623, 1619, 1621, 29, 3582, 2549, 3048, 2203, 3560, 2721, 435, 474, 49, 3741, 1422, 1423, 1, 10, 11, 12, 13, 2, 3, 4, 5, 6, 7, 8, 9, 1143, 2715, 2804, 1839, 3118, 1196, 50, 4570, 2705, 32, 1376, 1377, 1379, 1381, 2747, 65, 3313, 66, 68, 69, 70, 512, 796, 1919, 2639, 2155, 2156, 1922, 1095, 1096, 2323, 3496, 3497, 3870, 1288, 2570, 311, 3387, 3682, 4035, 4036, 423, 2030, 411, 2563, 2564, 2569, 2811, 2813, 2814, 2820, 2821, 2823, 2824, 2825, 3329, 3330, 3331, 3336, 3337, 3339, 3466, 3717, 3731, 3016, 2561, 2621, 2565, 4249, 4042, 3718, 3729, 3375, 2560, 2831, 2286, 2287, 3581, 4009, 1338, 2190, 2199, 1921, 2801, 1111, 2566, 3333, 4247, 4248, 4105, 4262, 2609, 2610, 1642, 2169, 3745, 2568, 4429, 3873, 2313, 3499, 2640, 2847, 2161, 2641, 3498, 3628, 1749, 495, 2567, 424, 1957, 4370, 4371, 4372, 4409, 4410, 4411, 4412, 4413, 3730, 4103, 2662, 2965, 3965, 4089, 4090, 3698, 3131, 3841, 596, 4253, 4391, 4049, 3957, 4579, 4582, 4557, 4455, 4548, 4598, 3479, 2124, 4098, 3324, 3299, 3728, 2031, 2771, 4404, 1924, 2121, 3033, 1923, 2772, 2337, 2338, 2002, 4097, 4224, 625, 911, 3478, 2800, 1125, 837, 3150, 2262, 2882, 3153, 3690, 3936, 3296, 2785, 3117, 4272, 4273, 3026, 2838, 3739, 3780, 3842, 3897, 391, 4153, 737, 1774, 221, 2377, 2544, 1822, 1831, 2045, 2439, 2744, 3328, 3588, 4162, 4163, 565, 3487, 4517, 4141, 2340, 3469, 999, 1169, 1347, 1400, 3428, 2542, 3681, 2389, 3471, 2425, 2546, 4152, 1346, 3578, 2545, 302, 1853, 2944, 3477, 2543, 1461, 1953, 3027, 3028, 3029, 3030, 3031, 516, 517, 518, 3890, 678, 901, 4177, 2547, 4149, 1459, 1590, 1275, 1392, 3468, 525, 573, 814, 2390, 4345, 222, 1276, 945, 3898, 300, 2760, 2149, 1652, 3284, 4165, 4168, 4119, 3283, 354, 2301, 3912, 2757, 1134, 2148, 328, 792, 2361, 4032, 2204, 2993, 3281, 140, 67, 2147, 3282, 3572, 3291, 3312, 3279, 34, 2409, 2144, 355, 1654, 1135, 312, 3917, 251, 3600, 2142, 2761, 1109, 2692, 3914, 2150, 2268, 250, 2989, 2756, 145, 1208, 2049, 4173, 4184, 4628, 3911, 299, 3574, 19, 2143, 2995, 1991, 356, 367, 2145, 1055, 2994, 1568, 2146, 2017, 18, 1845, 784, 2358, 4121, 3278, 3280, 3570, 3571, 2753, 1136, 254, 3913, 3915, 3003, 3004, 3005, 3006, 3007, 3008, 3009, 3010, 3011, 4102, 308, 1133, 1138, 1651, 1653, 1988, 1989, 1990, 1993, 1994, 2141, 2367, 2754, 2755, 2758, 2759, 2988, 2990, 2991, 2992, 3285, 3573, 3598, 3599, 3916, 4275, 4276, 785, 1062, 3910, 4183, 3023, 128, 2298, 3138, 2959, 3526, 1100, 2963, 2962, 503, 663, 664, 4456, 4457, 994, 1197, 134, 2261, 2173, 2057, 2058, 3793, 539, 3630, 4139, 2667, 639, 384, 538, 3744, 1833, 4085, 3597, 3848, 2322, 2657, 1235, 3784, 2677, 1975, 3370, 3371, 3368, 3369, 4143, 4271, 3115, 3302, 521, 2541, 2745, 3232, 3116, 2012, 4499, 1666, 2186, 2283, 2296, 2300, 2652, 2702, 3668, 3791, 3900, 4004, 4225, 4277, 4294, 4295, 4296, 4297, 4298, 4299, 4324, 4390, 660, 834, 838, 1992, 3304, 3788, 2070, 2868, 3986, 3987, 3675, 39, 2260, 1629, 583, 3751, 864, 313, 4260, 363, 2310, 2311, 4120, 1856, 2259, 504, 1102, 1103, 4107, 1162, 3381, 3434, 3024, 2528, 3676, 3363, 2181, 1711, 338, 1979, 1592, 4244, 4221, 1303, 4188, 1345, 1917, 1875, 1925, 1926, 3667, 488, 3247, 3018, 409, 3367, 3327, 3309, 1561, 1304, 2974, 4234, 2845, 1085, 4340, 1220, 2734, 3353, 3679, 2383, 3677, 4216, 2303, 4203, 2527, 1001, 397, 2164, 3476, 4341, 4342, 1788, 3158, 1046, 657, 680, 3147, 2072, 2364, 3034, 4039, 401, 119, 1344, 3437, 3036, 600, 2849, 4357, 1272, 2356, 1339, 3359, 3361, 1855, 4293, 3357, 120, 4087, 4213, 3467, 1238, 2314, 1049, 1343, 3651, 605, 1405, 3440, 1676, 2054, 844, 857, 2848, 3438, 3443, 2360, 2632, 2997, 3038, 3037, 642, 597, 2365, 1113, 3047, 383, 3757, 1783, 881, 2060, 2840, 2345, 3781, 3669, 1342, 2123, 361, 2529, 2282, 3384, 2317, 3442, 4219, 2302, 3611, 643, 3844, 3845, 3846, 3492, 3462, 3391, 2073, 2719, 627, 3253, 1969, 3315, 3406, 1421, 3575, 1073, 1980, 2996, 2870, 4104, 3248, 3390, 3635, 4329, 4358, 1946, 1947, 241, 2642, 2643, 3382, 3461, 1019, 1024, 1043, 1045, 2015, 3341, 4205, 4228, 4235, 4236, 4521, 2608, 4091, 3941, 1598, 4202, 4005, 1312, 2518, 3234, 2006, 3123, 3124, 2209, 3508, 4142, 2218, 3519, 3488, 2682, 4284, 3919, 2235, 4209, 4210, 2208, 2197, 3858, 2215, 4220, 2233, 2252, 3694, 3511, 3697, 2256, 3762, 2223, 3522, 2240, 4467, 2242, 2228, 3521, 4130, 2071, 2220, 2227, 3516, 3515, 3905, 1438, 2601, 2602, 2603, 2207, 2214, 2238, 3518, 3802, 3924, 2975, 2976, 3457, 2378, 3925, 3520, 2221, 4256, 3689, 4057, 4058, 4059, 4254, 2230, 2219, 2247, 1846, 2234, 3695, 4088, 3921, 2239, 2241, 2232, 3456, 4350, 2254, 2534, 3920, 2237, 2217, 2212, 3918, 4258, 2206, 2244, 2229, 2222, 2231, 3923, 2249, 2236, 3517, 3700, 2258, 3922, 4255, 4257, 4374, 2216, 4698, 2225, 3510, 3513, 2243, 3860, 3904, 3906, 3907, 3908, 3909, 3509, 4468, 3512, 2210, 2878, 3514, 2226, 2251, 2683, 3696, 3699, 2205, 2213, 2224, 3307, 3485, 2211, 3959, 2245, 840, 3430, 2704, 3632, 3633, 1206, 4453, 1669, 2777, 2780, 2781, 2792, 2793, 2794, 2795, 3639, 1444, 492, 3107, 2000, 122, 17, 2153, 1090, 1436, 2289, 507, 1128, 2531, 1297, 1398, 2312, 2368, 4292, 898, 899, 1401, 441, 3431, 2776, 2784, 3429, 2370, 2405, 3708, 317, 318, 548, 31, 533, 1146, 1941, 1985, 3862, 3692, 3693, 931, 1585, 1586, 1239, 1964, 3310, 4052, 4053, 1389, 3691, 64, 2050, 2407, 2408, 3840, 3674, 939, 2775, 2167, 3958, 196, 197, 45, 2871, 3128, 1167, 1709, 2698, 2699, 2700, 3396, 3397, 3398, 3399, 3400, 675, 1393, 4285, 2082, 2175, 3050, 2769, 4227, 4128, 1097, 4061, 121, 3252, 4308, 1059, 2765, 377, 3473, 1061, 4106, 833, 575, 2886, 2706, 1183, 1079, 3984, 3796, 3983, 123, 1937, 2079, 3347, 143, 3172, 3966, 4069, 1181, 2718, 1311, 2679, 2717, 2419, 1180, 2420, 2426, 4054, 4148, 4480, 1265, 2685, 3752, 3753, 769, 770, 4019, 2193, 2067, 4382, 4043, 3046, 1630, 2839, 3002, 2032, 1187, 1397, 988, 1087, 1283, 1088, 2063, 1282, 3609, 1819, 3159, 3017, 2062, 2964, 1918, 3301, 3303, 3605, 3608, 3020, 3624, 3625, 3606, 2201, 2805, 1114, 2191, 4015, 2055, 1523, 3645, 3646, 1987, 1285, 2094, 137, 3372, 3373, 4044, 3974, 1552, 4676, 4048, 3946, 4046, 3586, 3587, 3786, 3787, 4045, 4047, 1533, 1559, 3626, 3648, 2127, 2128, 3688, 416, 341, 4025, 3754, 2524, 570, 3794, 4214, 1281, 1571, 2678, 2727, 2741, 2743, 4145, 3049, 637, 650, 2768, 1052, 925, 926, 3481, 4175, 2723, 2726, 2730, 2735, 2736, 2960, 2971, 2973, 3288, 3365, 4016, 2645, 1776, 4505, 181, 2498, 2510, 3213, 3274, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 2499, 1150, 2423, 1460, 3212, 3218, 3275, 3211, 2557, 3839, 2266, 3634, 3221, 2472, 2475, 2508, 2514, 1152, 2504, 2511, 2501, 2521, 2444, 2445, 2471, 2509, 2520, 1105, 2513, 4408, 3132, 3258, 3277, 3286, 3289, 1230, 3195, 3223, 3259, 3260, 3262, 3263, 3266, 3261, 3376, 3377, 4174, 4178, 4179, 4180, 4181, 4182, 1153, 3214, 3269, 3273, 3216, 3226, 3267, 3268, 2440, 2442, 2443, 2516, 2742, 3215, 992, 30, 1163, 3222, 3276, 2500, 2507, 1558, 1620, 3219, 3264, 3265, 2505, 2424, 846, 3426, 3217, 574, 1179, 4375, 16, 1154, 3197, 3271, 3196, 3199, 3225, 3270, 3272, 4207, 4208, 3489, 439, 4376, 4483, 1556, 1557, 2391, 1213, 3323, 4315, 2441, 2474, 2506, 2517, 845, 906, 2470, 2502, 2503, 2512, 2515, 2519, 2522, 3647, 3960, 3961, 3962, 3963, 3964, 3220, 4026, 4031, 161, 762, 803, 804, 805, 869, 33, 166, 167, 168, 169, 1205, 937, 1036, 1037, 3709, 305, 306, 1038, 1209, 23, 568, 60, 1034, 1035, 3806, 1033, 1039, 104, 105, 107, 144, 146, 337, 593, 1044, 1056, 194, 24, 272, 273, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 4172, 883, 941, 155, 156, 157, 158, 866, 856, 510, 4665, 2600, 102, 2016, 511, 58, 1207, 940, 3484, 3482, 3969, 1382, 4436, 3408, 2160, 1375, 1383, 1780, 2651, 2998, 3144, 3146, 321, 3401, 3402, 3407, 3483, 3579, 40, 404, 1120, 2762, 3139, 3749, 215, 3403, 217, 3956, 1139, 3405, 3404, 3815, 3824, 3829, 3832, 3833, 3834, 3835, 3836, 3837, 3838, 3750, 1779, 4136, 3145, 2770, 4135, 2157, 3748, 3142, 4131, 322, 2158, 4134, 2418, 225, 3580, 3140, 4437, 2154, 216, 4132, 214, 2159, 3143, 4362, 4363, 3141, 4137, 4133, 182, 3756, 3852, 1671, 1670, 4310, 3540, 3641, 3642, 868, 2382, 3314, 1773, 4110, 1437, 4460, 2606, 2939, 3942, 3943, 3944, 2751, 2752, 1300, 1068, 1069, 1070, 2943, 3795, 546, 2476, 3427, 541, 3797, 2371, 2830, 1834, 2376, 3945, 4330, 3732, 1430, 55, 686, 4050, 1399, 4368, 1292, 3032, 2763, 3362, 3875, 1433, 4459, 2607, 1432, 3241, 3242, 3243, 3244, 4076, 2686, 2688, 3013, 4690, 3863, 4461, 1626, 2748, 2749, 2750, 51, 2615, 3861, 4349, 2092, 2093, 2095, 2826, 2827, 3704, 4647, 2525, 2526, 1618, 2562, 1643, 1660, 2076, 2120, 3970, 4084, 427, 3610, 1577, 4440, 1142, 3452, 3761, 795, 2151, 395, 1759, 3490, 2548, 634, 3129, 3475, 3640, 1971, 2655, 3589, 3590, 3591, 3701, 4328, 3246, 3710, 3711, 393, 882, 3171, 3902, 2183, 3507, 3705, 1426, 1427, 1420, 3903, 3792, 3472, 394, 2867, 1455, 1456, 2885, 3742, 3298, 3712, 3493, 3713, 3714, 3715, 831, 1958, 4318, 1232, 3725, 3746, 1403, 3727, 4212, 1575, 4051, 3789, 1464, 2018, 4140, 4419, 4420, 4422, 3594, 3670, 4316, 4317, 2309, 378, 3593, 4222, 1636, 3687, 4195, 1844, 2766, 3790, 1358, 1748, 2001, 2008, 2096, 2329, 1507, 3076, 683, 2999, 723, 753, 1906, 336, 73, 74, 2325, 2331, 3412, 1897, 3161, 3078, 3612, 998, 2059, 3775, 1494, 2933, 3065, 2922, 4344, 2009, 2915, 2924, 3000, 3620, 1263, 133, 2923, 1936, 603, 371, 3364, 2326, 2330, 38, 4126, 1093, 2492, 1843, 1132, 3074, 2953, 1501, 888, 97, 3111, 3866, 3867, 2034, 291, 99, 1457, 714, 484, 3613, 1566, 320, 2020, 498, 2327, 3245, 1505, 4075, 1178, 3105, 3664, 3088, 1948, 3239, 3240, 981, 3166, 3167, 3975, 4191, 1912, 2013, 3235, 3238, 2583, 3237, 3164, 3236, 2863, 2271, 3464, 2373, 1515, 859, 2064, 1094, 890, 741, 132, 4067, 4092, 3801, 3316, 3317, 3318, 3319, 3320, 3321, 447, 971, 2332, 2936, 207, 2921, 3053, 3062, 1223, 4074, 3500, 1508, 2671, 1970, 3126, 43, 1261, 3096, 2861, 719, 1563, 2019, 3998, 1320, 4100, 771, 4319, 2578, 2581, 526, 3615, 2599, 2047, 3042, 2163, 36, 659, 4080, 4081, 189, 705, 1933, 2196, 2496, 4082, 1497, 2491, 4332, 4333, 4334, 4336, 4011, 1517, 1520, 3977, 970, 3099, 1071, 293, 294, 2108, 2270, 2930, 4379, 2075, 1269, 368, 369, 1826, 1877, 3162, 986, 415, 531, 532, 738, 1447, 3880, 392, 2493, 3063, 171, 90, 2176, 2177, 2178, 1977, 2379, 470, 1228, 725, 744, 752, 1898, 3064, 3618, 3619, 4194, 2078, 3290, 3072, 1911, 1394, 419, 2932, 1909, 3764, 1499, 721, 1513, 3097, 802, 3803, 3804, 3805, 3614, 3067, 1262, 483, 359, 3379, 2586, 3073, 3081, 460, 461, 3306, 3039, 3160, 2967, 4127, 1895, 1996, 25, 775, 2925, 2626, 1510, 3084, 223, 2767, 1736, 3168, 2114, 2920, 1254, 3077, 3294, 2627, 2927, 37, 616, 2859, 2334, 2115, 1186, 2860, 3617, 4008, 976, 3114, 912, 3112, 2357, 2194, 997, 2585, 2954, 1414, 3094, 136, 3421, 3601, 3891, 1514, 3052, 2917, 2113, 3092, 1746, 3040, 1616, 1769, 2674, 2913, 1943, 1531, 1803, 1804, 1806, 1807, 739, 1827, 1496, 1465, 746, 56, 57, 1908, 1910, 3175, 501, 1914, 980, 1118, 1119, 3978, 2384, 3100, 4338, 2074, 1356, 2328, 985, 2022, 2112, 3622, 335, 1503, 3041, 3101, 2333, 2494, 2942, 1355, 1907, 4129, 3901, 2594, 2596, 130, 1894, 2592, 2597, 1954, 1633, 340, 3173, 3174, 2023, 977, 2107, 3779, 3864, 3108, 4150, 717, 2914, 972, 2117, 172, 174, 175, 3928, 2675, 2676, 614, 2051, 2572, 2024, 969, 472, 2005, 716, 1588, 2269, 2272, 2629, 2862, 3719, 2875, 274, 975, 2941, 3093, 374, 1407, 968, 98, 2109, 3759, 718, 745, 3976, 1896, 437, 1509, 1511, 1512, 2065, 3110, 3295, 1409, 2952, 2935, 615, 2275, 4070, 4071, 535, 1502, 1609, 4378, 4073, 2934, 1915, 95, 1741, 4314, 477, 478, 2116, 2919, 1256, 1359, 407, 469, 471, 1608, 375, 1913, 3305, 3929, 3292, 2035, 2672, 2673, 3071, 3233, 4021, 4325, 94, 1949, 1495, 2021, 3865, 4380, 2091, 982, 566, 1131, 4125, 1264, 3079, 455, 774, 3103, 3156, 3979, 1294, 3996, 1176, 456, 458, 459, 131, 743, 96, 1634, 3621, 1840, 4414, 4415, 2631, 809, 697, 1357, 1182, 2077, 2946, 487, 701, 877, 2027, 1518, 129, 3043, 2929, 2916, 2110, 2591, 2595, 1589, 2273, 326, 330, 967, 973, 3885, 2335, 2336, 1354, 35, 4022, 3871, 3662, 3934, 3935, 1955, 3061, 2274, 1935, 800, 978, 2007, 983, 2689, 613, 2928, 742, 2593, 2623, 1215, 3075, 1504, 1650, 4072, 2918, 1257, 438, 2832, 1498, 3231, 715, 2097, 1259, 1268, 1260, 720, 2111, 1644, 2955, 1607, 3070, 3486, 1962, 4146, 2644, 3086, 3616, 1905, 1934, 2979, 1516, 1519, 1770, 2864, 974, 2956, 984, 1506, 878, 4428, 2582, 2630, 1951, 1500, 2866, 1127, 691, 1638, 2931, 1978, 801, 46, 2029, 2028, 3229, 3776, 1415, 2162, 3250, 3445, 2598, 1258, 2791.
Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1346-2026 | Class II | Azurion 7 B12 System Model Numbers:(1) 722067,... | Jan 26, 2026 |
| Z-1350-2026 | Class II | Azurion 5 M12 System Model Numbers: (1)722227,... | Jan 26, 2026 |
| Z-1349-2026 | Class II | Azurion 7 M20 System Model Numbers: (1)722079,... | Jan 26, 2026 |
| Z-1348-2026 | Class II | Azurion 7 M12 System Model Numbers: (1)722078,... | Jan 26, 2026 |
| Z-1345-2026 | Class II | Azurion 3 M15 System Model Numbers: (1) 722064... | Jan 26, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.