Recall Z-0708-2025 ยท DPS Electrocardiograph
Braemar Manufacturing, LLC
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
| Date | Dec 23, 2024 (initiated Dec 18, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Use error |
| Action | On 12/18/2024, the firm sent an Urgent Medical Device Correction Letter via certified mail to customers informing them that it has been identified a software configuration issue that resulted in a percentage of ECG events received into Monitoring Service Application (MSA) were not properly routed due to the Secondary Analysis being disabled and subsequently there ECG events were not reviewed by a Cardiology Technician for inclusion in reporting. Importantly, some of the ECG events received into MSA during this period (July 2022-July 2024) met notification criteria for escalation to the orderin |
| Quantity | ~130,000 with 41,282 customers (1 software copy used) |
| Distribution | US Nationwide distribution including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.