Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac e...
FDA Recall #Z-0708-2025 — Class I — December 18, 2024
Product Description
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
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.
Recalling Firm
Braemar Manufacturing, LLC — San Diego, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
~130,000 with 41,282 customers (1 software copy used)
Distribution
US Nationwide distribution including PR.
Code Information
Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.