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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