The U.S. Food and Drug Administration (FDA) announced on Jan. 13 that Philips is correcting the Monitoring Service Application used with Mobile Cardiac Telemetry Monitoring as some electrocardiogram (ECG) events received by the application between July 2022 to July 2024 were not properly routed, which may have led to missing information or notifications.

According to the agency, “Some of the ECG events received into the application during this time period met criteria to be escalated back to ordering practitioners, but were not escalated to them,” which could have impacted clinical decision-making.

The FDA notes affected practices should check the Philips Prescriber Response Site to review which patients may need to have data reprocessed. Access the FDA website to learn more.

Keywords: ACC Advocacy, United States Food and Drug Administration, Electrocardiography, Outpatients