I think that any when any product is launched in the market, the tests and all the certain documents are already verified. However, when issues start with those products, they cannot recall just from one error found because it can be updated without machines or product recall. The FDA cannot predict every possible outcome of product or drug after it is out in the market. Some possible results are already quality tested and verified. Only after then it is out in the market. However, it is possible for a machine to be used differently than the normal way of using it, which causing the malfunction or creating issues with hardware. When the complaints are going beyond the limit and turn into life-threating, the manufacturer and the FDA both recalls the device or product to prevent the worst possible outcomes