Z-0708-2025Class I

Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG...

Name: Z-0708-2025 Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG...
Creator: Braemar Manufacturing, LLC
Published: 2024-12-18
License: https://open.fda.gov/license/

Braemar Manufacturing, LLC / initiated 2024-12-18 / Open, Classified / root cause: software

FDA source

Braemar Manufacturing, LLC began a recall of Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices on 2024-12-18. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0708-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-18
Posted: 2024-12-23
Recalling firm: Braemar Manufacturing, LLC
Product: Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Product code: DPS Electrocardiograph
Reason for recall: 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.
Root cause tag: software
FDA root cause: Use error
Action: 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.
Quantity in commerce: ~130,000 with 41,282 customers (1 software copy used)
Distribution: US Nationwide distribution including PR.
Product codes and lots: Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0708-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23

Product code DPS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)