Monitoring Service Application recall: Software Issue
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Why was Monitoring Service Application 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
- Product
- Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
- Recalling firm
- Braemar Manufacturing, LLC
- Quantity
- ~130,000 with 41,282 customers (1 software copy used)
- Distribution
- US Nationwide distribution including PR.
- Recall date
- January 1, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)