“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
The electrocardiograph (ECG) is a device that is used to record analyze and evaluate the records of the signal generated by cardiac activity. The records made with the ECG can be used to facilitate the diagnosis of cardiac function and cardiac conditions. The ECG is designed for indoor use and can be used for patients of both sexes, of all races and of all ages.