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FDAFDA · Food and drugs·Recall number Z-2065-2012

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.

Published August 1, 2012 · Recall initiated: November 20, 2006

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE OEC Medical Systems, Inc
Distributor
Worldwide Distribution - US Nationwide
Lot
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 , 6410PU
Risk classification
Class I
Area (FDA)
device
Country
United States

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