Braemar Manufacturing, LLC recalls Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from…
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.
Read the official notice →- Date
- 2025-01-01
- Country
- United States
- Brand
- Braemar Manufacturing, LLC
- Product
- Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from…
- Classification
- Class I
- Units
- US Nationwide distribution including PR.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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