The Recall Desk
SevereFDA (Devices)·Z-0708-2025·Announced 2025-01-01

Cardiac Monitoring Software Failed to Properly Route ECG Events

Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of cardiac monitoring software. The failure to properly route and analyze ECG cardiac events represents a serious medical device malfunction that could prevent detection of critical cardiac conditions requiring immediate clinical intervention, though no confirmed deaths or injuries are reported in the source.

Plain-English summary

Braemar Manufacturing is recalling the Monitoring Service Application (MSA), a software system designed to process, analyze, display, and report cardiac events detected in ECG data from compatible monitoring devices. The recall affects software versions 6.5 through 7.4.

Between July 2022 and July 2024, an analysis step in the software was disabled, preventing ECG events from being properly routed and reviewed. This software malfunction meant that cardiac events detected by compatible devices were not properly analyzed and reported through the monitoring system.

The recall affects approximately 130,000 software installations used by 41,282 customers across the United States, including Puerto Rico.

Customers using the Monitoring Service Application should contact Braemar Manufacturing regarding a software update or patch to restore proper ECG event routing and analysis functionality. Patients relying on this monitoring system should consult with their healthcare provider about the monitoring interruption.

The recalled product

Product
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Manufacturer
Braemar Manufacturing, LLC
Category
Medical Device — Cardiac Monitoring Software
Hazard
  • software-malfunction
  • ecg-routing-failure
  • missed-cardiac-detection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4

Distribution

Distributed nationwide across the United States.

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