Events

Rappel de Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex,

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68245
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1722-2014
  • Date de mise en oeuvre de l'événement
    2014-04-01
  • Date de publication de l'événement
    2014-06-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127208
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    A customer reported that the table top had become free floating. a field service engineer (fse) confirmed that the service latch had become disengaged.
  • Action
    Philips Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed If they experience a horizontal, free-floating couch motion, to contact their Field Service Engineer immediately. Customers were instructed to retain a copy of this Field Safety Notice with the equipment Instructions for USER Use (IFU). Customers with questions or needing further information were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America, contact the Customer Care Solutions Center at 1-800-722-9377, Option 5. For questions regarding this recall call 440-483-3032.

Device

Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex,
  • Modèle / numéro de série
    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, 6275-6277, 6279-6283, 6285, 6287-6304, 6306-6317, 6319-6325, 6327-6364, 6366-6370, 6373-6380, 6382-6387, 6389, 6392-6395, 6397-6416, 6418-6421, 6423-6444, 6447-6458, 6460-6493, 6497-6500, 6502-6532, 6534-6563, 6565-6577, 6580-6590, 6592-6616, 6618-6636, 6638-6640, 6643-6645, 6647, 6648, 6650-6655, 6657, 6658, 6660-6671, 6673, 6675-6718, 6720-6726, 6729, 6733, 6738, 6740-6743, 6745, 6751, 6753-6755, 6757- 6760, 6762-6768, 30019, 30041, 30061, 30069, 30081, 30091, 30093, 30097, 30109, 32287, 40002, 40003, 40020, 40022, 40027, 50002, 50003, 50005, 50007-50013, 50015, 50016, 50018, 50021-50023, 50025-50036, 50038, 50040-50042, 50044-50059, 50061-50070, 50073-50088, 50091-50099, 50101-50107, 50109-50113, 50115, 50116, 50118-50122, 50124-50129, 50131, 50133-50138, 50141-50166, 50168, 50170, 50172, 50175-50182, 50184-50195, 50197-50200, 50202, 50204, 50206-50208, 50210 & 270001.  Brilliance CT 16 Power: M/N: 728240; S/N: 3004, 3046, 3100, 3109, 3236, 5003, 5043, 5047, 5071, 5345, 5356, 5374, 5390, 5395, 5413, 5430, 5455, 5467, 6007, 6009-6011, 6013, 6024, 6026-6028, 6031-6038, 6041-6043, 6045-6049, 6051-6060, 6062-6067, 6069-6072, 6075, 6077-6090, 6093, 6095, 6096, 6099-6113, 6115-6117, 6119, 6121-6126, 6129-6137, 6139, 6141-6151, 6153-6156, 6159, 6161-6163, 50039, 50073, 60001-60006, 60008-60014, 60017, 60022, 60024, 60025 & 60027-60029.  Brilliance CT 40: M/N: 728235; S/N: 4012, 9031, 9032, 9034, 9036, 9039, 9046, 9047, 9050, 9053, 9055, 9057, 9060, 9061, 9076, 9085, 9088, 9094, 9095, 9097, 9103, 9109, 9111, 9113-9116, 9119, 9122, 9124, 9125, 9128-9134, 9136, 9141, 9144-9147, 9149, 9150, 9153, 9154, 9157, 9158, 9161, 9164, 9165, 9167-9170, 9172, 9174, 9176, 9178-9183 9185, 9186, 9188, 9189, 9191-9194, 9198-9200, 9203,9204, 9207,9209-9212, 9219, 9222, 9225-9233, 9237-9241, 9244, 9245, 9247-9251, 9253, 9254, 9256-9258, 9260-9273, 9275, 9276, 9278-9282, 9284-9286, 29001, 29004, 29006-29008, 29010-29013, 29015, 29019-29024, 29028-29031, 29033, 29036, 29038-29041, 29043, 29046-29048, 29050, 29051, 29055, 29058-29061, 29063-29067, 29069, 29071-29073, 29075, 29077, 29078, 29080, 29082-29087, 29089-29091, 29093-29096, 29098-29106, 29108, 29109, 29113, 29114, 29116-29123, 29125, 29127-29132, 29134-29137, 29139,29140-29145, 29147-29150, 29152, 29153, 90034, 90035, 90040, 90043, 90044, 90049, 90051-90054, 90056, 90059, 90061, 90064, 90065, 90067, 90069, 90071, 90075, 90076, 90083, 90084, 90087, 90090, 90093, 90095, 90101, 90103, 90108-90110, 90121, 90122, 90125, 90126, 90130, 90138, 90142, 90144, 90146, 90148, 90149, 90155, 90157-90159, 90164-90166, 90169, 90171-90174, 90178, 90179, 90181, 90183, 90184, 90186, 90189, 90190, 90192-90194, 90196-90198, 90200, 90202-90204, 90206-90215, 90219, 90220, 90222, 90224, 90226, 90228, 90229, 90231-90237 & 92034.  Brilliance CT 64: M/N: 728231; S/N: 4001, 4003, 4016, 4020, 5006, 9029, 9030, 9033-9035, 9037, 9038, 9040, 9041, 9043-9045, 9048, 9049, 9051, 9052, 9054, 9056, 9058, 9059, 9062, 9064-9075, 9077, 9080, 9083, 9086, 9087, 9089, 9092-9094, 9098, 9099, 9104-9108, 9112, 9117, 9118, 9120, 9121, 9126, 9127, 9135, 9137, 9138, 9140-9143, 9148, 9151, 9152, 9155, 9156, 9159, 9160, 9162, 9163, 9166, 9171, 9173, 9175, 9177, 9187, 9190, 9195-9197, 9201, 9202, 9205, 9206, 9208, 9213-9218, 9235, 9236, 9243, 9255, 9259, 9501-9505, 9507-9512, 9514-9531, 9533-9536, 9538-9543, 9545-9552, 9554-9566, 9568, 9569, 9570, 9572-9585, 9587-9596, 9598-9608, 9610, 9612-9620, 9622-9655, 9657-9659, 9662-9668, 9670-9674, 9676-9680, 9683-9695, 9697-9703, 9705-9714, 9716, 9718-9720, 9722-9726, 9728-9732, 9734-9742, 9745-9761, 9763, 9765-9769, 9772-9782, 9784-9795, 9797, 9800, 9801, 9803-9813, 9815-9822, 9824, 9826, 9829, 9830, 9832-9835, 9837-9847, 9849-9853, 9858-9871, 9873-9879, 9881-9885, 9888-9896, 9898, 9899, 9901-9906, 9909-9911, 9913-9927, 9929-9934, 9936-9938, 9940-9942, 9944-9948, 9950-9956, 9958-9961, 9963-9971, 9974-10009, 10011-10028, 10031-10037, 10039-10042, 10044-10054, 10056-10073, 10075, 10077-10081, 10083-10090, 10092, 10094-10108, 10110-10132, 10134-10137, 10139-10146, 10148-10158, 10160-10162, 10164-10168, 10170-10174, 10176-10198, 10200-10235, 10237-10239, 10241-10245, 10247, 10248, 10250-10283, 10286-10288, 10291-10305, 10307-10319, 10321-10327, 10330-10339, 10341-10353, 10355, 10357-10381, 10383-10386, 10388-10402, 10404-10422, 10424-10432, 10435-10492, 10494-10500, 10502-10523, 10525-10528, 10530-10535, 10537-10543, 10545-10619, 10621-10671, 10673, 10675-10681, 10683-10689, 10691-10708, 10710, 10712-10715, 10717, 10718, 10720-10745, 10747-10762, 10765, 10767-10786, 10789, 10790, 10792, 10793, 10795-10804, 29002, 29003, 29005, 29014, 29016-29018, 29025, 29026, 29032, 29034, 29035, 29037, 29044, 29045, 29049, 29053, 29054, 29056, 29057, 29062, 29066, 29068, 29070, 29092 ,29101, 29107, 29113, 29115, 29124, 29138, 29151, 32129, 64015, 64016-64020, 64022-64039, 64041-64080, 64082-64094, 64096-64104, 64106-64112, 64115-64118, 64121-64131, 64133-64140, 64142, 64143-64154, 64157, 64158, 64160, 64162-64169, 64171-64175, 65006, 90029-90031, 90036, 90037, 90041, 90042, 90046-90048, 90057, 90058, 90060, 90062, 90063, 90066, 90070, 90072, 90074, 90077-90082, 90084-90089, 90091, 90092, 90094, 90096-90100, 90105-90107, 90117-90120, 90123, 90124, 90129, 90131, 90132, 90135-90137, 90139-90141, 90143, 90147, 90150-90154, 90156, 90160, 90161, 90163, 90167-90170, 90175-90177, 90180, 90182, 90187, 90195, 90199, 90205-90208, 90213, 90218, 90221-90223, 91003, 95003, 95008, 95009, 95011-95024, 95029-95052, 95054-95069, 95071-95076, 95078-95085, 95088-95095, 95097-95104, 95106-95114, 95116-95119, 95121-95123, 95125-95129, 95132-95143, 95147, 95149, 95151, 95153, 95154, 95157, 95161, 95162, 95165-95170, 95177, 95178, 95181-95186, 95189-95191, 95194, 95195, 95197, 95199, 95201-95204, 95207-95210, 95214, 95216-95219, 95221-95223, 95227, 95228, 95231-95234, 95236-95239, 95242, 95243, 95245-95247, 95249-95254, 95257-95259, 95261, 95262, 95264-95266, 95268-95271, 95273-95287, 95289-95294, 95296-95298, 95300, 95301, 95303-95305, 95308-95310, 95312-95335, 95338, 95342, 95344-95346, 95348-95351, 95353-95366, 95369, 95370, 95374-95376, 95378-95400, 95402-95404, 95406, 95408-95411, 95413-95436, 95438-95440, 95442-95458, 95460-95492, 95494-95529, 95531-95584, 95586, 95588-95592, 95595-95641, 95643-95662, 95664-95700, 95702-95727, 95729-95761, 95764-95770, 95772-95812, 95814-95832, 95835-95845, 95848-95858, 95860-95862, 95864-95876, 95878, 95879, 95884, 95920, 96494, 100062, 110058, 110391 & 999999.   Brilliance CT Big Bore Oncology: M/N: 728243; S/N: 7006-7009, 7013-7051, 7053-7062, 7064-7120, 7122-7142, 7144-7166, 7168, 7169, 7171, 7173-7175, 7177-7179, 7181, 7183-7186, 7188, 7189, 7191, 7192, 7194-7199, 7201-7214, 7216-7243, 7245-7247, 7249, 7250, 7253-7263, 7265-7267, 7269, 7270, 7272-7289, 7291-7295, 7297-7300, 7302, 7304, 7306-7316, 7319, 7320, 7322-7374, 7376-7379, 7381,7382, 7387-7389, 7392, 7393, 7395, 7397-7401, 7403-7406, 7409,7410,7411-7422, 7424-7426, 7428, 7429, 7431-7433, 7435-7438, 7440-7451, 7454-7457, 7459, 7461-7471, 7473-7475, 7477-7485, 7487-7509, 7511-7513, 7515-7524, 7526-7528, 7530-7532, 7534, 7535, 7537, 7539-7542, 7545, 7547-7556 ,7558-7561, 7563-7569, 7573, 7574,7577-7582, 7584, 7585, 7588-7593, 7596-7599, 7601-7603, 7605, 7606, 7608, 7609, 7611-7613, 7615-7618, 7620, 7622-7624, 7626-7630, 7634, 7635, 7637-7650, 7652, 7655-7659, 7661, 7662, 7665-7667, 7671, 7672, 7674, 7675, 7677-7681, 7684, 7685, 7687, 7689-7691, 7693, 7695, 7696, 7698-7707, 7709, 7715, 7716, 7718, 7720, 7724-7727, 7729-7731, 7735-7737, 7739-7741, 7743-7745, 7749-7755, 7757, 7759, 7761-7763, 7765, 7769, 7770, 7774-7777, 7779, 7782-7788, 7791, 7793-7797, 7799-7803, 7806-7808, 7810-7812, 7814, 7815, 7817, 7818, 7820, 7822-7824, 7827-7829, 7831-7838, 7840-7842, 7846-7852, 7855-7858, 7860, 7861, 7864-7868, 7872, 7873, 7875-7877, 7881, 7884, 7886, 7891-7893, 7895, 7896, 7898, 7900-7902, 7904, 7905, 7907-7911, 7914, 7916, 7918, 7920, 7921, 7923-7925, 7927-7929, 7931-7933, 7935-7942, 7944-7946, 7948-7950, 7955, 7956, 7963, 7968, 7970, 7972, 7973, 7976, 7984, 7987, 7990, 7991 & 7993.  Brilliance CT Big Bore Radiology: M/N: 728244; S/N: 7052, 7063, 7121, 7155, 7172, 7176, 7180, 7182, 7190, 7200, 7244, 7252, 7268, 7271, 7301, 7318, 7375, 7380, 7383, 7384, 7386, 7390, 7396, 7402, 7407, 7408, 7427, 7430, 7439, 7452, 7453, 7458, 7486, 7510, 7514, 7525, 7529, 7533, 7538, 7543, 7546, 7570, 7572, 7575, 7583, 7586, 7587, 7594, 7595, 7604, 7610, 7614, 7619, 7621, 7625, 7631, 7632, 7633, 7636, 7651, 7653, 7654, 7660, 7668-7670, 7676, 7683, 7686, 7688, 7692, 7694, 7697, 7708, 7710-7714, 7717, 7719, 7721-7723, 7732-7734, 7738, 7742, 7746, 7747, 7756, 7760, 7764, 7766, 7767, 7771-7773, 7778, 7780, 7781, 7789, 7790, 7798, 7804, 7809, 7813, 7819, 7825, 7826, 7830, 7839, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7943, 7952,7958, 7959, 7964, 7967, 7986, 7988 & 7992.  Brilliance iCT: M/N: 728306; S/N: 85000, 100016, 100019-100025, 100028, 100031, 100032, 100037-100040, 100042-100074, 100077-100079, 100081-100084, 100086-100106, 100108-100135, 100137-100142, 100144-100155, 100157-100182, 100184-100236, 100238, 100240, 100242-100254, 100256-100268, 100270-100278, 100280-100283, 100285-100297, 100299-100325, 100327, 100329-100332, 100334, 100336, 100338-100343, 100345-100350, 100352-100358, 100360-100365, 100368-100380, 100382-100389, 100391, 100393-100402, 100404-100412, 100414-100418, 100423-100426, 100429, 100430, 100433-100435, 100438-100442, 100449-100458, 100460-100462, 100464-100470, 100473, 100476, 100477, 100480-100482, 100484-100486, 100488, 100490, 100493, 100494, 100497-100499, 100503, 100505-100508, 100511, 200005, 200083, 200098 & 987654.  Brilliance iCT SP: M/N: 728311; S/N: 100039, 100062, 200003, 200006-200016, 200018-200027, 200029-200058, 200060-200065, 200067, 200068-200071, 200073-200079, 200084-200097, 200099-200117, 200119, 200120, 200123-200131, 200133-200137.  Ingenuity CT: M/N: 728326; S/N: 6372, 6395, 6569, 10607, 300005, 300011, 300012, 300014, 300016-300022, 300024, 300025, 300027-300042, 300044-300066, 300068, 300069, 300071-300075, 300077-300082, 300084-300114, 300116-300133, 300135-300140, 300142-300145, 300147-300151, 300156-300163, 300164 & 310058.  Ingenuity Core: M/N: 728321; S/N: 6563, 7700, 10614, 10621, 10633, 50171, 50204, 95732, 100507, 310001, 310004, 310006, 310008, 310009, 310010, 310012-310015, 310017, 310018, 310020-310022, 310024-310026, 310028-310035, 310037-310057, 310059-310143, 310146-310148, 310156, 310157, 310159, 333001-333003, 333005-333012, 333016 & 3100016.  Ingenuity Core128: M/N: 728323; S/N: 100315, 320002-320011, 320013-320015, 320017-320112, 320115, 320119, 320123, 320126, 320131-320133, 320135, 320136, 320140, 336001-336003, 336006-336008 & 336014.  MX8000 Dual v. EXP: M/N: 728130; S/N: 2110, 8010, 8016, 8018, 8034, 8035, 8039-8041, 8043, 8048, 8053, 8055, 8056, 8058, 8061, 8065, 8067, 8068, 8070, 8073-8077, 8079, 8081, 8082, 8084-8086, 8092, 8095, 8097, 8098, 8104, 8105-8108, 8111, 8112, 8114-8120, 8123-8125,8127-8131, 8134-8138, 8140, 8142-8147, 8149-8151, 8153-8156, 8159, 8160, 8163-8165, 8167-8169, 8171-8175, 8177, 8178, 8181, 8184-8186, 8188, 8190-8192, 8194-8196, 8198, 8199, 8201-8208, 8211-8213, 8215-8218, 8220, 8221, 8223, 8225-8227, 8232-8240, 8242, 8243, 8245, 8247-8250, 8253, 8256-8258, 8260-8289, 8292-8296, 8298-8306, 8308, 8310-8315, 8317, 8318, 8320-8324, 8326, 8328-8335, 8337-8342, 8344-8347, 8349, 8351-8355, 8357-8359, 8361-8373, 8375-8396, 8398, 8400-8407, 8409-8413, 8442, 9528, 80002-80005, 80007, 80009-80019, 80021 & 80022.  Ingenuity Flex: M/N728317; S/N: 260002, 260003, 340002, 340003, 345002, 345003 & 345004.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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)
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA