FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported
The U.S. Food and Drug Administration (FDA) has announced that Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry (MCOT) devices after certain high-risk electrocardiogram (ECG) events were never routed to trained cardiology technicians as intended. This is a Class I recall, the FDA’s most serious classification.
This issue, which lasted from July 2022 to July 2024, has been associated with 109 patient injuries and two patient deaths. Some of the health events included suspected cases of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia and second- or third-degree atrioventricular block.
On Dec. 18, 2024, Philips and its subsidiary, Braemar Manufacturing, sent all customers impacted by the failure an Urgent Medical Device Correction and information on how to review which patients may need to have their data reprocessed.
MCOT image taken during HRS 2023. Photo by Dave Fornell.
No devices need to be returned or removed
No medical devices are being returned or removed from the market as a result of this recall. Instead, customers have been instructed to read and follow the instructions provided on the Urgent Medical Device Correction. If any ECGs have been reprocessed, the customer will be notified via email when the updated reports are ready to be reviewed. Any new cardiac events identified in these updated reports will be summarized.
“Philips will not communicate with patients directly about this issue,” according to the FDA’s advisory. “If patients have been impacted as part of this issue, healthcare providers have the responsibility to inform patients and/or update a patient’s care pathway.”
Philips acquired these MCOT devices, in addition to other advanced monitoring technologies, when it agreed to acquire Pennsylvania-based BioTelemetry for $2.8 billion in late 2020. The transaction was finalized in February 2021.
Read the full recall advisory on the FDA website.
Philips shares a statement
Philips has issued a new statement highlighting its efforts to make customers aware of this issue.
“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 company said in its statement. “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.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.