GE OEC Medical Systems, Inc OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion. Recall
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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According to the U.S. Food and Drug Administration (FDA)
Product
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
2791PU2, 2792PU0, 2793PU8, 2795PU3, 2797PU9, 2799PU5, 2800PU1, 2801PU9, 2802PU7, 2803PU5, 2805PU0, 2806PU8, 2807PU7, 2808PU4, 2831PU6, 2832PU4, 2834PU0, 2835PU7, 2895PU1, 2897PU7, 2899PU3, 2900PU9, 2902PU5, 2903PU3, 2904PU1, 2905PU8, 2906PU6 & 4365PU3, 2907PU4, 3096PU5, 3097PU3, 3098PU1, 3099PU9 & 3100PU5, 3103PU9, 3104PU7, 3105PU4, 3107PU0, 3110PU4, 3111PU2, 3113PU8 & 3119PU5, 3118PU7, 3120PU3, 3121PU1, 3217PU7 & 5204PU3, 3218PU5, 3224PU3, 4380PU2 & 4387PU7, 3226PU8, 3228PU4, 3232PU6, 3233PU4, 3363PU9, 3364PU7 & 4386PU9, 3365PU4, 3367PU0, 3368PU8, 3369PU6, 3370PU4, 3371PU2, 3377PU9, 3378PU7, 3379PU5, 3380PU3, 3503PU0, 3504PU8, 3505PU5, 3506PU3, 3511PU3 & 4856PU1, 3512PU1, 3513PU9, 3514PU6, 3515PU4, 3516PU2, 3518PU8, 3519PU6, 3520PU4, 3521PU2, 3522PU0 & 3523PU8, 3524PU6 & 4023PU8, 3525PU3, 3526PU1, 3527PU9, 3529PU5, 3531PU1, 3532PU9, 3533PU7, 3534PU5, 3535PU2, 3559PU2, 3560PU0, 3563PU4, 3568PU3, 3569PU1, 3572PU5, 3573PU3, 3578PU2, 3589PU9, 7702PU4, 3591PU5, 3593PU1, 3594PU9, 3945PU3, 3946PU1, 3947PU9, 3948PU7, 3949PU5, 3950PU3, 3951PU1, 3952PU9, 3953PU7 & 3954PU5, 3962PU8 & 5624PU2, 3963PU6, 3964PU4, 3965PU1, 3966PU9, 3967PU7, 3968PU5 & 3969PU3, 3970PU1, 3972PU7, 3988PU3, 3989PU1, 3990PU9, 3991PU7, 4025PU3, 4026PU1, 4031PU1, 4032PU9, 4033PU7, 4034PU5, 4037PU8, 4038PU6, 4041PU0, 4042PU8, 4043PU6, 4044PU4, 4366PU1, 4367PU9, 7369PU2, 4369PU5, 4370PU3, 4371PU1, 4375PU2, 4377PU8, 4379PU4, 4384PU4, 4385PU1, 4388PU5, 4389PU3, 4393PU5, 4394PU3, 4396PU8, 4428PU9, 4429PU7, 4430PU5, 4437PU0, 4442PU0, 4445PU3 & 4766PU2, 4447PU9 & 4456PU0, 4451PU1, 4452PU9, 4453PU7, 4459PU4, 4460PU2, 6406PU3, 6989PU8, 4462PU8, 4464PU4, 4767PU0, 4768PU8, 4769PU6, 4770PU4, 4774PU6, 4777PU9, 4780PU3, 4781PU1 & 5207PU6, 4814PU0 & 4815PU7, 4816PU5, 4817PU3, 4818PU1, 4819PU9, 4822PU3, 4823PU1, 4825PU6, 4826PU4, 4830PU6, 4836PU3, 4841PU3, 4842PU1, 4843PU9, 4845PU4, 4846PU2, 4847PU0, 4848PU8, 4849PU6, 4851PU2, 4853PU8, 4854PU6, 4857PU9, 4858PU7, 4860PU3, 4864PU5, 5165PU6, 5169PU8, 5171PU4, 5188PU8, 5190PU4, 6485PU7, 5194PU6, 5195PU3, 5196PU1, 5197PU9, 5198PU7, 5199PU5, 5200PU1, 5201PU9, 5203PU5, 5205PU0, 5206PU8, 5210PU0, 5211PU8, 5212PU6, 5213PU4, 5214PU2, 5215PU9, 5216PU7, 5217PU5, 5218PU3, 5220PU9, 5221PU7, 5222PU5, 5223PU3, 5257PU1, 5263PU9, 5264PU7, 5604PU4, 5605PU1, 5606PU9, 5607PU7, 5608PU5, 5611PU9, 5612PU7, 5614PU3, 5617PU6, 5619PU2, 5620PU0 & 5626PU7, 5622PU6, 5623PU4, 5625PU9, 5627PU5, 5628PU3, 5631PU7, 5632PU5, 5633PU3, 5636PU6, 5637PU4, 5639PU0, 5641PU6 & 5694PU5, 5642PU4, 5643PU2 & 6005PU3, 5662PU2, 5664PU8, 5667PU1, 5693PU7, 5696PU0, 5697PU8, 5699PU4 & 6018PU6, 6003PU8, 6007PU9, FIB-0027, FIB-0031, FIB-0033, FIB-0010, FIB-0011, FIB-013, FIB-0034, FIB-035, FIB 0041, FIB-0036, 6489PU9, FIB-0037, FIB-0038, FIB-0039, FIB-0040, FIB-0042, FIB-0043, FIB-0045, FIB-0046, FIB-0047, FIB-0048, FIB-0049, FIB-0050, FIB-0062, FIB-0063, FIB-0065, 6014PU5, 6471PU7, 6019PU4, 6020PU2, 6022PU8, 6038PU4, 6056PU6, 6487PU3, 6059PU0, 6061PU6, 6062PU4, 6063PU2, 6066PU5, 6071PU5, 6072PU3, 6073PU1, 6959PU1, 6075PU6, 6087PU1, 6089PU7, 6090PU5, 6095PU4, 6099PU6, 6407PU1, 6409PU7, 6410PU5, 6447PU7, 6448PU5, 6451PU9, 6459PU2, 6464PU2, 6467PU5, 6469PU1, 6470PU9, 6473PU3, 6477PU4, 6488PU1, 6492PU3, 6494PU9, 6500PU3, 6514PU4, 6900PU5, 6911PU2, 6912PU0, 6919PU5, 6918PU7, 6921PU1, 6922PU9, 6925PU2, 6927PU8, 6929PU4, 6934PU4, 6935PU1, 6936PU9, 6955PU9, 6957PU5, 6958PU3, 6959PU1, 6963PU3, 6964PU1, 6985PU6, 6995PU5, 6998PU9, 6999PU7, 7300PU7, 7311PU4, 7312PU2, 7313PU0, 7315PU5, 7316PU3, 7318PU9, 7320PU5, 7322PU1, 7323PU9, 7324PU7, 7330PU4, 7341PU1, 7362PU7, 7363PU5, 7364PU3, 7365PU0, 7366PU8, 7368PU4, 7373PU4, 7372PU6, 7375PU9, 7383PU3, 7384PU1, 7385PU8, 7389PU0, 7390PU8, 7391PU6, 7392PU4, 7393PU2, 7395PU7, 7398PU1, 7399PU9, 7720PU6, 7721PU4, 7725PU5, 7724PU8, 7728PU9, 7729PU7, 7747PU9, 2161PU8, 2212PU9, 2213PU7, 2214PU5, 2219PU4, 2220PU2, 2221PU0, 2222PU8, 2225PU1, 2794PU6, 2796PU1, 2798PU7, 2809PU2, 2810PU0, 2811PU8, 2812PU6, 2813PU4, 2814PU2, 2815PU9, 2816PU7, 2817PU5, 2818PU3, 2819PU1, 2820PU9, 2821PU7, 2822PU5, 2823PU3, 2824PU1, 2825PU8, 2826PU6, 2827PU4, 2828PU2, 2829PU0, 2830PU8, 2833PU2, 2896PU9, 2898PU5, 2901PU7, 2908PU2, 2909PU0, 2910PU8, 2911PU6, 2912PU4, 2913PU2, 2914PU0, 2915PU7, 2916PU5, 2917PU3, 2918PU1, 2919PU9, 2920PU7, 2921PU5, 2922PU3, 2923PU1, 2924PU9, 2925PU6, 2926PU4, 2927PU2, 2928PU0, 2929PU8, 2930PU6, 2931PU4, 2932PU2, 2933PU0, 2934PU8, 2935PU5, 2936PU3, 2937PU1, 2938PU9, 2939PU7, 2940PU5, 2941PU3, 2942PU1, 3095PU7, 3101PU3, 3102PU1, 3106PU2, 3108PU8, 3109PU6, 3112PU0, 3114PU6, 3115PU3, 3116PU1, 3117PU9, 3122PU9, 3219PU3, 3220PU1, 3221PU9, 3222PU7, 3223PU5, 3225PU0, 3227PU6, 3229PU2, 3230PU0, 3231PU8, 3234PU2, 3235PU9, 3236PU7, 3237PU5, 3238PU3, 3239PU1, 3240PU9, 3241PU7, 3242PU5, 3243PU3, 3244PU1, 3357PU1, 3358PU9, 3359PU7, 3360PU5, 3362PU1, 3372PU0, 3373PU8, 3374PU6, 3375PU3, 3376PU1, 3381PU1, 3382PU9, 3383PU7, 3384PU5, 3495PU9, 3496PU7, 3497PU5, 3498PU3, 3499PU1, 3500PU6, 3501PU4, 3502PU2, 3507PU1, 3508PU9, 3509PU7, 3510PU5, 3517PU0, 3530PU3, 3536PU0, 3537PU8, 3538PU6, 3539PU4, 3540PU2, 3541PU0, 3542PU8, 3543PU6, 3544PU4, 3545PU1, 3546PU9, 3547PU7, 3548PU5, 3549PU3, 3550PU1, 3551PU9, 3552PU7, 3553PU5, 3554PU3, 3555PU0, 3556PU8, 3557PU6, 3558PU4, 3561PU8, 3562PU6, 3564PU2, 3565PU9, 3566PU7, 3567PU5, 3570PU9, 3571PU7, 3574PU1, 3575PU8, 3576PU6, 3580PU8, 3581PU6, 3584PU0, 3585PU7, 3586PU5, 3587PU3, 3588PU1, 3590PU7, 3592PU3, 3955PU2, 3956PU0, 3957PU8, 3958PU6, 3959PU4, 3960PU2, 3961PU0, 3971PU9, 3974PU3, 3975PU0, 3976PU8, 3977PU6, 3978PU4, 3979PU2, 3980PU0, 3981PU8, 3982PU6, 3983PU4, 3984PU2, 3985PU9, 3986PU7, 3987PU5, 3993PU3, 3994PU1, 3995PU8, 3996PU6, 3997PU4, 3998PU2, 3999PU0, 4000PU6, 4001PU4, 4002PU2, 4003PU0, 4005PU5, 4007PU1, 4008PU9, 4009PU7, 4010PU5, 4011PU3, 4012PU1, 4013PU9, 4014PU7, 4015PU4, 4016PU2, 4017PU0, 4018PU8, 4019PU6, 4020PU4, 4021PU2, 4022PU0, 4024PU6, 4027PU9, 4028PU7, 4029PU5, 4030PU3, 4036PU0, 4039PU4, 4372PU9, 4374PU5, 4376PU0, 4378PU6, 4381PU0, 4382PU8, 4383PU6, 4390PU1, 4391PU9, 4397PU6, 4399PU2, 4400PU8, 4401PU6, 4402PU4, 4403PU2, 4404PU0, 4405PU7, 4406PU5, 4407PU3, 4408PU1, 4409PU9, 4410PU7, 4411PU5, 4412PU3, 4413PU1, 4414PU9, 4415PU6, 4416PU4, 4417PU2, 4418PU0, 4419PU8, 4420PU6, 4421PU4, 4422PU2, 4423PU0, 4424PU8, 4425PU5, 4426PU3, 4427PU1, 4431PU3, 4432PU1, 4433PU9, 4434PU7, 4435PU4, 4436PU2, 4438PU8, 4439PU6, 4440PU4, 4441PU2, 4443PU8, 4444PU6, 4446PU1, 4448PU7, 4449PU5, 4450PU3, 4454PU5, 4455PU2, 4457PU8, 4458PU6, 4463PU6, 4765PU4, 4773PU8, 4775PU3, 4779PU5, 4782PU9, 4783PU7, 4784PU5, 4785PU2, 4786PU0, 4787PU8, 4788PU6, 4789PU4, 4790PU2, 4791PU0, 4792PU8, 4793PU6, 4794PU4, 4795PU1, 4796PU9, 4797PU7, 4798PU5, 4799PU3, 4800PU9, 4801PU7, 4802PU5, 4803PU3, 4804PU1, 4813PU4, 4820PU7, 4824PU9, 4827PU2, 4828PU0, 4829PU8, 4831PU4, 4832PU2, 4833PU0, 4834PU8, 4835PU5, 4837PU1, 4838PU9, 4839PU7, 4840PU5, 4844PU7, 4850PU4, 4852PU0, 4855PU3, 4859PU5, 4861PU1, 4862PU9, 4863PU7, 5166PU4, 5167PU2, 5168PU0, 5170PU6, 5172PU2, 5174PU8, 5175PU5, 5176PU3, 5177PU1, 5178PU9, 5179PU7, 5180PU5, 5181PU3, 5182PU1, 5183PU9, 5184PU7, 5185PU4, 5186PU2, 5192PU0, 5193PU8, 5202PU7, 5208PU4, 5209PU2, 5219PU1, 5224PU1, 5226PU6, 5227PU4, 5229PU0, 5230PU8, 5231PU6, 5232PU4, 5233PU2, 5234PU0, 5236PU5, 5239PU9, 5240PU7, 5241PU5, 5242PU3, 5249PU8, 5250PU6, 5251PU4, 5252PU2, 5253PU0, 5254PU8, 5255PU5, 5256PU3, 5258PU9, 5259PU7, 5260PU5, 5261PU3, 5600PU2, 5602PU8, 5603PU6, 5609PU3, 5610PU1, 5613PU5, 5615PU0, 5616PU8, 5618PU4, 5629PU1, 5630PU9, 5634PU1, 5635PU8, 5644PU0, 5645PU7, 5646PU5, 5647PU3, 5648PU1, 5649PU9, 5650PU7, 5651PU5, 5652PU3, 5653PU1, 5654PU9, 5655PU6, 5658PU0, 5659PU8, 5660PU6, 5661PU4, 5666PU3, 5668PU9, 5669PU7, 5670PU5, 5671PU3, 5672PU1, 5673PU9, 5674PU7, 5675PU4, 5676PU2, 5677PU0, 5678PU8, 5679PU6, 5680PU4, 5681PU2, 5682PU0, 5683PU8, 5684PU6, 5685PU3, 5686PU1, 5687PU9, 5688PU7, 5690PU3, 5695PU2, 6002PU0, 6006PU1, 6008PU7, 6009PU5, 6010PU3, 6012PU9, 6013PU7, 6015PU2, 6017PU8, 6021PU0, 6031PU9, 6032PU7, 6035PU0, 6036PU8, 6037PU6, 6040PU0, 6041PU8, 6042PU6, 6046PU7, 6047PU5, 6048PU3, 6049PU1, 6051PU7, 6052PU5, 6053PU3, 6055PU8, 6057PU4, 6058PU2, 6064PU0, 6065PU7, 6067PU3, 6068PU1, 6069PU9, 6070PU7, 6074PU9, 6076PU4, 6077PU2, 6078PU0, 6079PU8, 6080PU6, 6081PU4, 6082PU2, 6083PU0, 6084PU8, 6085PU5, 6086PU3, 6088PU9, 6092PU1, 6093PU9, 6094PU7, 6098PU8, 6100PU2, 6101PU0, 6408PU9, 6413PU9, 6414PU7, 6416PU2, 6417PU0, 6418PU8, 6419PU6, 6420PU4, 6421PU2, 6422PU0, 6423PU8, 6424PU6, 6425PU3, 6426PU1, 6427PU9, 6428PU7, 6429PU4, 6430PU3, 6431PU1, 6432PU9, 6433PU7, 6434PU5, 6435PU2, 6436PU0, 6437PU8, 6438PU6, 6439PU4, 6440PU2, 6441PU0, 6442PU8, 6443PU6, 6444PU4, 6445PU1, 6446PU9, 6449PU3, 6452PU7, 6453PU5, 6454PU3, 6455PU0, 6457PU6, 6458PU4, 6460PU0, 6461PU8, 6462PU6, 6463PU4, 6465PU9, 6472PU5, 6474PU1, 6475PU8, 6476PU6, 6479PU0, 6480PU8, 6483PU2, 6484PU0, 6486PU5, 6490PU7, 6491PU5, 6493PU1, 6495PU6, 6496PU4, 6498PU0, 6499PU8, 6501PU1, 6502PU9, 6503PU7, 6504PU5, 6505PU2, 6507PU8, 6901PU3, 6903PU9, 6904PU7, 6905PU4, 6906PU2, 6907PU0, 6908PU8, 6910PU4, 6914PU6, 6915PU3, 6917PU9, 6920PU3, 6923PU7, 6926PU0, 6928PU6, 6930PU2, 6932PU8, 6933PU6, 6937PU7, 6939PU3, 6940PU1, 6941PU9, 6942PU7, 6943PU5, 6944PU3, 6945PU0, 6946PU8, 6947PU6, 6948PU4, 6949PU2, 6950PU0, 6953PU4, 6956PU7, 6961PU7, 6962PU5, 6966PU6, 6967PU4, 6969PU0, 6970PU8, 6971PU6, 6972PU4, 6973PU2, 6974PU0, 6975PU7, 6977PU3, 6978PU1, 6979PU9, 6981PU5, 6982PU3, 6983PU1, 6984PU9, 6986PU4, 6987PU2, 6988PU0, 6990PU6, 6991PU4, 6992PU2, 6994PU8, 6996PU3, 6997PU1, 7301PU5, 7302PU3, 7303PU1, 7305PU6, 7306PU4, 7309PU8, 7310PU6, 7319PU7, 7325PU4, 7326PU2, 7328PU8, 7329PU6, 7331PU2, 7332PU0, 7334PU6, 7335PU3, 7336PU1, 7337PU9, 7339PU5, 7340PU3, 7342PU9, 7343PU7, 7348PU6, 7349PU4, 7350PU2, 7352PU8, 7353PU6, 7354PU4, 7355PU1, 7356PU9, 7357PU7, 7358PU5, 7360PU1, 7367PU6, 7370PU0, 7377PU5, 7381PU7, 7382PU5, 7387PU4, 7397PU3, 7700PU8, 7701PU6, 7703PU2, 7704PU0, 7706PU5, 7708PU1, 7709PU9, 7710PU7, 7711PU5, 7712PU3, 7713PU1, 7714PU9, 7715PU6, 7716PU4, 7717PU2, 7718PU0, 7722PU2, 7723PU0, 7726PU3, 7731PU3, 7732PU1, 7733PU9, 7734PU7, 7735PU4, 7736PU2, 7737PU0, 7739PU6, 7741PU2, 7742PU0, 7743PU8, 7754PU5, 7940PU0, 7941PU8, 7944PU2, 7945PU9, 7951PU7, FGW0001, FGW0002, FGW0003, FGW0004, FGW0005, FGW0006, FGW0007, FGW0008, FGW0009, FGW0010, FGW0011, FGW0012, FGW0013, FGW0014, FGW0015, FGW0017, FGW0018, FIB0006, FIB0008, FIB0014, FIB0015, FIB0016, FIB0024, FIB0044, FIB0052, FIB0053, FIB0054, FIB0055, FIB0056, FIB0058, FIB0059, FIB-0060, FIB-0061, FIB0064, FIB0066, FIB0067
Products Sold
2791PU2 , 2792PU0 , 2793PU8 , 2795PU3 , 2797PU9 , 2799PU5 , 2800PU1 , 2801PU9 , 2802PU7 , 2803PU5 , 2805PU0 , 2806PU8 , 2807PU7 , 2808PU4 , 2831PU6 , 2832PU4 , 2834PU0 , 2835PU7 , 2895PU1 , 2897PU7 , 2899PU3 , 2900PU9 , 2902PU5 , 2903PU3 , 2904PU1 , 2905PU8 , 2906PU6 & 4365PU3 , 2907PU4 , 3096PU5 , 3097PU3 , 3098PU1 , 3099PU9 & 3100PU5 , 3103PU9 , 3104PU7 , 3105PU4 , 3107PU0 , 3110PU4 , 3111PU2 , 3113PU8 & 3119PU5 , 3118PU7 , 3120PU3 , 3121PU1 , 3217PU7 & 5204PU3 , 3218PU5 , 3224PU3, 4380PU2 & 4387PU7 , 3226PU8 , 3228PU4 , 3232PU6 , 3233PU4 , 3363PU9 , 3364PU7 & 4386PU9 , 3365PU4 , 3367PU0 , 3368PU8 , 3369PU6 , 3370PU4 , 3371PU2 , 3377PU9 , 3378PU7 , 3379PU5 , 3380PU3 , 3503PU0 , 3504PU8 , 3505PU5 , 3506PU3 , 3511PU3 & 4856PU1 , 3512PU1 , 3513PU9 , 3514PU6 , 3515PU4 , 3516PU2 , 3518PU8 , 3519PU6 , 3520PU4 , 3521PU2 , 3522PU0 & 3523PU8 , 3524PU6 & 4023PU8 , 3525PU3 , 3526PU1 , 3527PU9 , 3529PU5 , 3531PU1 , 3532PU9 , 3533PU7 , 3534PU5 , 3535PU2 , 3559PU2 , 3560PU0 , 3563PU4 , 3568PU3 , 3569PU1 , 3572PU5 , 3573PU3 , 3578PU2 , 3589PU9, 7702PU4 , 3591PU5 , 3593PU1 , 3594PU9 , 3945PU3 , 3946PU1 , 3947PU9 , 3948PU7 , 3949PU5 , 3950PU3 , 3951PU1 , 3952PU9 , 3953PU7 & 3954PU5 , 3962PU8 & 5624PU2 , 3963PU6 , 3964PU4 , 3965PU1 , 3966PU9 , 3967PU7 , 3968PU5 & 3969PU3 , 3970PU1 , 3972PU7 , 3988PU3 , 3989PU1 , 3990PU9 , 3991PU7 , 4025PU3 , 4026PU1 , 4031PU1 , 4032PU9 , 4033PU7 , 4034PU5 , 4037PU8 , 4038PU6 , 4041PU0 , 4042PU8 , 4043PU6 , 4044PU4 , 4366PU1 , 4367PU9, 7369PU2 , 4369PU5 , 4370PU3 , 4371PU1 , 4375PU2 , 4377PU8 , 4379PU4 , 4384PU4 , 4385PU1 , 4388PU5 , 4389PU3 , 4393PU5 , 4394PU3 , 4396PU8 , 4428PU9 , 4429PU7 , 4430PU5 , 4437PU0 , 4442PU0 , 4445PU3 & 4766PU2 , 4447PU9 & 4456PU0 , 4451PU1 , 4452PU9 , 4453PU7 , 4459PU4 , 4460PU2, 6406PU3, 6989PU8 , 4462PU8 , 4464PU4 , 4767PU0 , 4768PU8 , 4769PU6 , 4770PU4 , 4774PU6 , 4777PU9 , 4780PU3 , 4781PU1 & 5207PU6 , 4814PU0 & 4815PU7 , 4816PU5 , 4817PU3 , 4818PU1 , 4819PU9 , 4822PU3 , 4823PU1 , 4825PU6 , 4826PU4 , 4830PU6 , 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GE OEC Medical Systems, Inc is recalling OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 88 due to Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by th. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026