Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data recei
Summary
The FDA issued a Class I for Monitoring Service Application (MSA). Software to process, analyze, display, and by Braemar Manufacturing, LLC. Reason: Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being d.
Details
Source
Device Recall
External ID
Z-0708-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Lot/Code Info: Product Code: N/A UDI code: N/A Software Version - 6.5 to 7.4
Quantity Affected: ~130,000 with 41,282 customers (1 software copy used)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-18
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Braemar Manufacturing, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Braemar Manufacturing, LLC have FDA actions?
This is the only FDA action we have on record for Braemar Manufacturing, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0708-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29