What is an example of a significant risk that leads to a device being classified as banned?

A device is classified as banned when it poses a significant risk associated with substantial deception or unreasonable public health risks. This classification reflects the regulatory stance that the potential harm or danger presented by the device is so severe that it warrants an outright prohibition, ensuring that public health and safety are protected.

In this context, "substantial deception" refers to cases where the device may mislead users or healthcare professionals about its effectiveness or safety, and "unreasonable public health risks" indicates that the device could lead to serious health consequences that outweigh any potential benefits. This measure is vital in maintaining trust in medical devices and safeguarding the public from products that could lead to significant harm or misinform critical health decisions.

Other options typically involve lesser risks or are situations that can be readily corrected or managed. Reversible minor side effects do not constitute significant risk, as they are not harmful in the long term. Temporary malfunctions under testing suggest the device needs further evaluation or modification, rather than outright banning. Common manufacturing defects could point to issues regarding quality control, but they do not automatically lead to a device being considered unsafe to the extent that a ban is required.