Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-1722-2014

Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)

Publicado el 11 de junio de 2014 · Inicio del retiro: 1 de abril de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips Medical Systems (Cleveland) Inc
Distribuidor
Worldwide Distribution: US nationwide including PR and DC, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Cape Verde, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Herzegovina, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, LAO People's Dem, Rep., Latvia, Lebanon, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nahar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam & Yemen.
Lote
Brilliance CT 6: M/N: 728256; S/N: 3001, 3002, 3005, 3007, 3014, 3016, 3019-3021, 3025, 3026, 3028, 3032-3036, 3045, 3046, 3049, 3051, 3052, 3057, 3058, 3060, 3062, 3064-3066, 3068, 3071, 3073, 3074, 3076-3081, 3083, 3084, 3090, 3093-3095, 3097, 3101, 3102, 3104, 3106-3108, 3112-3115, 3118-3121, 3124, 3126, 3128, 3129, 3131, 3132, 3134, 3136, 3137, 3139-3141, 3143-3145, 3147, 3148, 3151-3158, 3162, 3165-3169, 3171, 3173-3177, 3180, 3181, 3184-3190, 3192, 3193, 3196, 3200, 3201, 3203, 3204, 3207, 3208, 3210-3218, 3220, 3221, 3225, 3226, 3228, 3229, 3232, 3235, 3237, 3240, 3241, 3243-3245, 3248, 3249, 3253-3257, 3260-3264, 3266-3272, 3275-3282, 3284, 3285, 3287, 3290, 3292, 3296, 3299, 3301, 3303-3305, 3307-3311, 3313, 3315, 3317-3323, 3325-3328, 3332-3334, 3336, 3338, 3339, 3341, 3343-3345, 3347-3349, 3351, 3352, 3354, 3357-3364, 3366-3368, 3370-3374, 3377-3384, 3386, 3388-3391, 3394, 3396-3400, 3402-3404, 3408, 3409, 3412, 3413, 3415-3418, 3423-3426, 3428-3432, 3434-3437, 3439, 3443, 3444, 3447, 3449, 3451-3453, 3455, 3457, 3459, 3460, 3461, 3463, 3465, 3467-3475, 3477-3483, 3485, 3486, 3488, 3489, 3491-3506, 3508-3511, 3513, 3515, 3517-3519, 3522-3524, 3526, 3527, 3532-3535, 3537-3549, 3551-3553, 3556-3559, 3562, 3564, 3566, 3568, 3570, 3571, 3573-3575, 3577, 3578, 3580, 3582-3588, 3590-3595, 3597-3608, 3611-3616, 3618-3622, 3625-3632, 3634-3637, 3639-3646, 3648, 3649, 3651-3661, 3663-3665, 3667-3670, 3672, 3674-3677, 3679-3693, 3695-3698, 3703-3712, 3714, 3715, 3717-3720, 3722, 6039, 6040, 30003, 30005, 30007-30009, 30011-30018, 30021, 30022, 30024, 30026-30031, 30033-30040, 30042, 30043, 30045-30048, 30050, 30052-30054, 30056-30062, 30064-30066, 30068, 30069, 30072, 30073, 30075, 30077-30080, 30082-30090, 30092, 30094, 30100, 30101, 30104-30108, 30111, 30113, 30117-30119, 30121-30131 & 300043. Brilliance CT 10: M/N: 728251; S/N: 3008, 3098, 4001, 4003, 4005, 4006, 4009-4012, 4014, 4016, 4020, 4021, 4023, 4026, 4027, 4029-4031, 4035, 4040, 4041, 4044, 4047-4050, 4052-4054, 4058, 4059, 4061, 4063-4067, 30099, 40006-40012, 40014-40018, 40021, 40023, 40024, 40028, 40030 & 40032-40035. Brilliance CT 16: M/N: 728246; S/N: 3011, 3013, 3018, 3027, 3031, 3038, 3041, 3043, 3070, 3072, 3082, 3085, 3117, 3127, 3149, 3160, 3205, 3216, 3227, 3293-3295, 3302, 3306, 3324, 3336, 3376, 3393, 3466, 3490, 3514, 3521, 3563, 3565, 3624, 3647, 3673, 3721, 4004, 4017, 4018, 4019, 4024, 4025, 4036, 4043, 4055, 5001, 5004-5008, 5010-5021, 5023-5026, 5028-5032, 5034-5038, 5040-5042, 5044-5046, 5049-5055, 5058-5062, 5064, 5066-5070, 5072-5076, 5078, 5081-5086, 5088-5095, 5097-5099, 5101-5105, 5107, 5108, 5110-5118, 5120-5128, 5130-5141, 5143, 5145-5152, 5155, 5156, 5158, 5160-5164, 5166-5170, 5173-5181, 5183-5202, 5204, 5207-5209, 5211-5219, 5221-5226, 5228-5240, 5242, 5243, 5248, 5249, 5252-5254, 5258, 5264-5267, 5269-5275, 5278, 5279, 5281-5283, 5285-5297, 5301-5309, 5311-5313, 5315-5320, 5322, 5323, 5325-5332, 5334, 5336, 5338-5344, 5346-5351, 5353, 5355, 5357, 5359-5362, 5365-5369, 5371, 5372, 5375-5380, 5382, 5384, 5386-5389, 5394, 5396-5400, 5402-5410, 5414-5429, 5432-5435, 5437-5443, 5451, 5452, 5456, 5460, 5468, 5469, 5485, 5489, 5515, 5522, 5531, 5535, 5537, 5543, 5552, 5555, 5557, 5567, 5581-5584, 5586-5588, 5600, 5607, 5621, 5624, 5630, 5642, 5644, 5645, 5651, 5654, 5658, 5663, 5664, 5667, 5675, 5679, 5684, 5685, 5697, 5707, 5709, 5716, 5724, 5725, 5735, 5738, 5743-5745, 5748-5750, 5752, 5754, 5756, 5772, 5774, 5776, 5777, 5780, 5782, 5790, 5793, 5794, 5796, 5801, 5802, 5806, 5807, 5812-5815, 5823-5827, 5830-5834, 5840-5849, 5851, 5852, 5854, 5855, 5857, 5858, 5860, 5861, 5866, 5871-5873, 5880, 5881, 5882, 5884-5886, 5892, 5899, 5901, 5904, 5915, 5921-5923, 5939-5942, 5947, 5948, 5961-5963, 5966-5968, 5976, 5980, 6011, 6012, 6014, 6015, 6028, 6033, 6034, 6036-6038, 6045, 6050, 6068-6071, 6082, 6090, 6095, 6104, 6105, 6108, 6112, 6115, 6126, 6132, 6133, 6161-6165, 6173, 6180, 6221, 6240, 6241-6243, 6245-6257, 6259-6262, 6264-6273, 6
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta