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The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).
A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
No 510(k) marketing clearance for the product