RecallRadar
FDA · Medical devicesClass I

Braemar Manufacturing, LLC medical device recall: Monitoring Service Application

Software problems

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
95837
Recall initiated
Dec 18, 2024
Classified by FDA
Dec 23, 2024
Posted in Enforcement Report
Jan 1, 2025
Recalling firm
Braemar Manufacturing, LLC
Firm location
San Diego, CA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Dec 18, 2024. FDA classified it 5 days later, on Dec 23, 2024. Distribution reported by FDA: US Nationwide distribution including PR. Braemar Manufacturing, LLC has 2 recalls in our records.

Recalled products (1)

  • Z-0708-2025 Class I Ongoing

    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

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

    Quantity: ~130,000 with 41,282 customers (1 software copy used)

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 95837
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.