CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report
Philips Medical Systems Computed Tomography X-ray systems recalled
Philips Medical Systems (Cleveland) is recalling Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT, distributed nationwide in the US. The recall was initiated on 1 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1722-2014
- FDA event ID
- 68245
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2014
- FDA classified
- 4 Jun 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 1 Apr 2014 | Recall initiated by company | |
| 4 Jun 2014 | Classified by FDA | +64 days |
| 11 Jun 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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)
Where it was distributed
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.
Questions about this recall
Is Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT recalled?
Yes. Philips Medical Systems (Cleveland) recalled Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT on 1 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1722-2014.
Why was it recalled?
A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems (Cleveland)
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pinnacle Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Packaging Defects | Nationwide |
| Device | CLASS II | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Device Malfunction | Nationwide |
| Device | CLASS II | Pinnacle3 Radiation Therapy Planning System recalled | Philips Medical Systems (Cleveland) | Other | 21 states |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
| Device | CLASS I | Forte Gamma Camera System is intended to produce images recalled | Philips Medical Systems (Cleveland) | Other | Nationwide |
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All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |