510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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Z-1722-2014Class II

Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT...

Philips North America LLC / initiated 2014-04-01 / Terminated / root cause: design
FDA source (opens on fda.gov)

Philips Medical Systems (Cleveland) Inc began a recall of Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex... on . FDA classified it as Class II and gives the reason as "A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1722-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
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)
Product code
JAK System, X-Ray, Tomography, Computed
Reason for recall
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 tag
design
FDA 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 in commerce
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.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1722-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1722-2014Class IITerminatedVoluntary: Firm initiated