Boston Scientific Corporation: Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA. Quantity: 7,649 apps Lot/code info: GTIN 00802526618215, Versions 2.0.101, 2.0.110

UPC codes

00802526618215

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.