This updated guidance is not based on new test results and is intended to provide broader options for physicians advising patients of affected devices to better account for a wide variety of clinical use cases for patient medical conditions. FDA’s recommendations in connection with these recalls. recall notifications for certain CPAP, BiPAP and Mechanical Ventilator devices to align them with the U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.įollowing ongoing dialogue with the FDA, Philips has updated the guidance in its JU.S. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.Īs a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.Īt that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
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