“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.
AXESSE, SYNERGY and INFINITY, MONACO software version v5.11 and 5.20, specific serials.
Descripción del producto
This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved.
This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved.
This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved
AXESSE, SYNERGY and INFINITY, MONACO software version v3.1 and later, specific serials.
Descripción del producto
This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved.