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December 23, 2024
23
Dec

FDA Recall: ECG Events Not Reviewed – Disabled in Monitoring Software

December 23, 2024
Company: Braemar Manufacturing, LLC Date of Enforcement Report: 12/23/2024 Class I PRODUCT Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. Recall Number: Z-0708-2025 REASON: Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an...
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