FDA Medical devices recall ·
Monitoring Service Application (MSA) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0708-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Braemar Manufacturing, LLC
3890 Murphy Canyon Rd Ste 100, San Diego, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- ~130,000 with 41,282 customers (1 software copy used)
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
Distribution
US Nationwide distribution including PR.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0708-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.