FDA-Device2024-10-30Class II
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Boston Scientific Corporation
Hazard
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
Sold states
Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.
Affected count
7,649 apps
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0226-2025Don't want to check this manually?
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