Telemetry

Philips Recalls Cardiac Telemetry Software Due to Serious ECG Events

by

Atlanta, Georgia – The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Philips software linked to its Mobile Cardiac Outpatient Telemetry (MCOT) devices due to a failure to route high-risk electrocardiogram (ECG) events to trained cardiology technicians. This serious issue occurred over a two-year period, resulting in 109 patient injuries … Read more

FDA Warns iRhythm Technologies Over Zio Cardiac Telemetry Device Violations

by

San Francisco, California – The U.S. Food and Drug Administration (FDA) recently sent a warning letter to iRhythm Technologies regarding issues related to their Zio AT mobile cardiac telemetry device. The letter, dated May 25, was made public on the agency’s website on June 6, shedding light on various concerns the FDA had with the … Read more