FDA Classifies Philips’ MCOT Device Recall as Most Severe Due to Software Flaws Leading to Patient Deaths and Injuries
Washington, D.C. – The U.S. Food and Drug Administration (FDA) has recently announced a major recall concerning the software used in Philips’ Mobile Cardiac Outpatient Telemetry (MCOT) devices, sparked by a critical failure in the system’s ability to alert healthcare professionals to severe heart-related events. This recall is classified as Class I, indicating that the … Read more