Recall of Device Recall OEC 8800 Flexview,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62387
  • Event Risk Class
    Class 1
  • Event Number
    Z-2065-2012
  • Event Initiated Date
    2006-11-20
  • Event Date Posted
    2012-07-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-05-13
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • Reason
    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.
  • Action
    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. GE Healthcare sent two Urgent Recall Notice letters to the Facility Administrator and the Radiology Administrator. The letters identified the affected product, problem and actions to be taken. The letters advised consignees that GE Healthcare is actively working on solutions that will permanently resolve each of the issues. For questions or concerns contact GE Healthcare service team at 800-874-7378 option 8.

Device

  • Model / Serial
    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 ,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA