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U.S. Department of Health and Human Services

Class 1 Device Recall Monitoring Service Application (MSA)

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 Class 1 Device Recall Monitoring Service Application (MSA)see related information
Date Initiated by FirmNovember 20, 2024
Date PostedDecember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0708-2025
Recall Event ID 95837
Product Classification Electrocardiograph - Product Code DPS
ProductMonitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Code Information Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
Recalling Firm/
Manufacturer		 Braemar Manufacturing, LLC
3890 Murphy Canyon Rd Ste 100
San Diego CA 92123-4448
For Additional Information ContactPrescriber Letter Response Line
888-521-1684
Manufacturer 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.
FDA Determined
Cause 2		Use error
ActionOn 11/20/2024, 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.
Quantity in Commerce~130,000 with 41,282 customers (1 software copy used)
DistributionUS Nationwide distribution including PR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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