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mb698 replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
Recall is used when the manufacturer takes a correction or removal action to address a problem with a medical device that violates the FDA rules. Recalls is done when there is any defect in the medical device which could cause the risk to health. There could be many reasons for the recall like inspecting the device for the problems, repairing the device, adjusting the setting on the device, notifying the patients of the problems and monitoring patients for the health issues. The reason for the recalling late is because the company finds the defects itself. There should more trials and experiments done before it is launched in the market. The recall can be avoided through stronger commitment to product design and quality.