Philips Medical Systems (Cleveland) Inc: 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)

Recall number

Z-1722-2014

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

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)

Status

Terminated

Initiated

2014-04-01

Posted

2014-06-04

Terminated

2018-06-26

Reason

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

Root cause

Component design/selection

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.

Quantity

6, 839 units

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.

Lot, serial or model codes

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.

510(k) numbers

["K010817","K012009","K033326","K033357","K060937"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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