FDA Medical Device Recalls (openFDA)
Braemar Manufacturing, LLC: Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
- Recall number
- Z-0708-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2024-12-18
- Posted
- 2024-12-23
- Terminated
- not on file
- Reason
- 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
- 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
- ~130,000 with 41,282 customers (1 software copy used)
- Distribution
- US Nationwide distribution including PR.
- Lot, serial or model codes
- Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 3003584029
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28