Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
This recall is currently active, issued December 23, 2024. It was issued by Braemar Manufacturing, Llc.
- Company
- Braemar Manufacturing, Llc
- Recall Initiated
- December 18, 2024
- Posted
- December 23, 2024
- Recall Number
- Z-0708-2025
- Quantity
- ~130,000 with 41,282 customers (1 software copy used)
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution including PR.
Lot / Code Info
Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
Root Cause
Use error
Action Taken
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 ordering practitioners but were not escalated. This may have resulted in missing information in the reports or notifications you received, which could have impacted your clinical decision-making. Philips is offering to have the prescription reprocessed to include the ECG events not initially routed to a Cardiology Technician. An Updated Communication to be sent will include Actions to be taken by customers: . Review the list of Frequently Asked Questions relating to this issue. . Log onto the Prescriber Response Site at https://prs.gobio.com with the Location Code provided in the header of this letter. . Read and acknowledge the receipt of this Urgent Medical Device Correction Letter on the website . Review the list of your patients and select whether and on which patients you wish reprocessing to be performed options available include reprocessing All, None, or Selected specific patients on the site. For questions/assistance-contact Prescriber Response Line 888-521-1684.