LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
Why it was recalled
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
UDI-DI: 00802526613838 — N/A
Record details
Boston Scientific Corporation — Worldwide - US Nationwide distribution.