“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.
Product: Philips Efficia DFM100 Defibrillator/ Monitor with model numbers 866199.
Units Affected: World Wide devices with certain configurations only: AED Only, AED+SpO2, AED+CO2 or AED+SpO2 +NBP.
Product : Philips HeartStart MRx Monitor/Defibrillator
Model : M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288,861289, 861464, 861483, 861491
Units affected: Serial numbers within the range US00100204 to US00570921