Philips Statement On Mobile Cardiac Telemetry (MCT) Service and Event Diagnostic Service Recall

Acting fast on post market surveillance signals, we proactively identified a software configuration issue and reported a medical device correction, offering clinicians the possibility of reprocessing potentially affected prescriptions. The service is now working normally, and with patient safety as our number one priority we continue to methodically work through quality at all levels in a multi-year program. 

Background 

Philips has intensified our efforts to strengthen patient safety and quality across the company. We are methodically working through quality at all levels in a multi-year program and acting fast on post market surveillance signals. We proactively identified an issue and reported a medical device correction, in co-ordination with the U.S. Food and Drug Administration (FDA), for the Mobile Cardiac Telemetry (MCT) Service and Event Diagnostic Service regarding a software configuration issue in the application used to process data from a wearable device. The FDA has designated this correction as a Class I recall under Braemer, a subsidiary of Philips. This recall does not involve returning any medical device, nor updating the device’s software. It is an advice update to clinicians with instructions for reprocessing a limited number of patient prescriptions.