Medical Electronics Symposium Conference Proceedings


Author: Gerry Padnos
Company: Juki Automation Systems
Date Published: 9/12/2006   Conference: Medical Electronics Symposium

Abstract: In certain cases, the ability to trace materials used to the exact product they were used in can be very valuable for recall and product quality purposes. The most common and obvious cases are where there is an increased risk of product liability, such as medical and automotive devices, but other industries are adopting it as well. The failure of a digital camera causes little more than inconvenience to the owner, but the failure of an air bag or pacemaker can cost the user his or her life. In these cases, traceability is a necessity to ensure the safety of the users. If a device had to be recalled due to a defect, it is critical to know exactly which products need to be recalled. From the manufacturer’s point of view, the two key elements of a recall would be ensuring that all affected products are recalled and minimizing the costs related to the recall effort. Recalling products that don’t contain any defective materials is simply a waste of time and money. Without traceability data, a company would potentially have to recall many more products than needed costing more money. Even worse, products that need to be recalled could be overlooked, potentially putting human life at risk. Traceability is the tool that provides this data for the SMT assembly process. Key words: traceability, medical assembly, FDA, product recall

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