FDAFDA · Food and drugs·Recall number Z-0226-2025
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Published October 30, 2024 · Recall initiated: September 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.
- Lot
- GTIN 00802526618215, Versions 2.0.101, 2.0.110
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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