The FDA announced today that a Philips
(NYSE: PHG)
recall involving remote cardiac monitoring software is Class I, its most serious recall designation.
On Dec. 18, 2024, Philips and its subsidiary Braemar Manufacturing sent health provider customers an Urgent Medical Device Correction, notifying them that, in some cases, the monitoring service application for its MCOT (BTPS-1000) devices failed to route some ECG events properly.
In a statement shared with MassDevice, Philips said the problem involved a small percentage of ECG events.
“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.”
The misrouting, which took place between July 2022 to July 2024, meant that cardiology technicians did not review certain ECG events for potential reporting to ordering clinicians. Events that could get routed to an ordering clinician included algorithm-identified episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third-degree AV block.
The FDA says it is aware of 109 reported injuries and two reports of death related to the recall, which affects 41,282 U.S. customers.
Said Philips: “At the time of this notification, Philips was made aware of reports of two potential adverse events, but their cause and the role of the system in the event, if any, is unknown.”
The Urgent Medical Device Correction included a location code for health providers to log onto a Prescriber Response Site at https://prs.gobio.com to review which patients may need ECG data reprocessed. The FDA has more details on its website.
The latest Class I recall comes as Philips seeks to move beyond a significant respiratory devices recall that involved millions of CPAPs and other devices. As a result, the Dutch medtech giant says it has intensified efforts to strengthen patient safety and quality across the company.
Remote heart monitoring is a hot space with companies including iRhythm, Baxter’s Bardy DX, and AliveCor selling technologies. Philips made a strong move into remote heart monitoring through its $2.8 billion acquisition of BioTelemetry in 2021.
