The FDA classifies recalls in three categories depending on the health hazard presented by the product being recalled: If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. A medical device recall does not always mean that you must stop using the product or return it to the company. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. What is a Medical Device Recall? A recall is an action taken to address a problem with a medical device that violates FDA law. SeptemJoe DiLeonardo Cath Lab Operating Rooms Operational Efficiency Patient Safety Radiology The Business of Surgery
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