Defibrillator - Implantable Cardioverter ATLAS II AND EPIC II
Model / Serial
CD1377-36C, CD1377-36QC, CD2377-36C and CD2377-36QC
Designed to administer ventricular antitachycardia and ventricular defibrillation for the automatic treatment of ventricular arrhythmias that endanger the life of the patient. Addition of indication: indication for magnetic resonance imaging, for MRI cardioid defibrillators models CD2377-36Q, CD2377-36QC, CD1377-36Q, CD1377-36QC and QUADRAASSURA cardioid defibrillators models CD3367-40QC, CD3367-40Q and QUADRAASSURA MP models CD3371-40QC, CD3371- 40Q. The cardiofibrillators FORTIFY ASSURA DR models CD2359-40Q, CD2359- CD2359-40QC, and FORTIFY ASSURAVR models CD1359-40Q, CD1359-40QC; they are conditional to magnetic resonance, the use of these devices conditionally safe in the MRI environment if a conditional DAI system is used to complete MRI.
“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.