Braemar Manufacturing, LLC recalls Monitoring Service Application (MSA). Software to process

Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

On 12/18/2024, the firm sent an Urgent Medical Device Correction Letter via certified mail to customers informing them that it has been identified a software configuration issue that resulted in a percentage of ECG events received into Monitoring Service Application (MSA) were not properly routed due to the Secondary Analysis being disabled and subsequently there ECG events were not reviewed by a Cardiology Technician for inclusion in reporting. Importantly, some of the ECG events received into MSA during this period (July 2022-July 2024) met notification criteria for escalation to the ordering practitioners but were not escalated. This may have resulted in missing information in the reports or notifications you received, which could have impacted your clinical decision-making. Philips is offering to have the prescription reprocessed to include the ECG events not initially routed to a Cardiology Technician. An Updated Communication to be sent will include Actions to be taken by customers: . Review the list of Frequently Asked Questions relating to this issue. . Log onto the Prescriber Response Site at https://prs.gobio.com with the Location Code provided in the header of this letter. . Read and acknowledge the receipt of this Urgent Medical Device Correction Letter on the website . Review the list of your patients and select whether and on which patients you wish reprocessing to be performed options available include reprocessing All, None, or Selected specific patients on the site. For questions/assistance-contact Prescriber Response Line 888-521-1684.

• FDA enforcement recordOfficial FDA database entry for Z-0708-2025
• FDA device classification · DPSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.2340The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Braemar Manufacturing, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.