Recall Z-3083-2026
- Recall number
- Z-3083-2026
- Event number
- 99524
- Firm
- Boston Scientific Corporation
- Firm FEI
- 2124215
- Product code
- MXD
- Status
- Open, Classified
- Initiated
- 2026-08-06
- Posted
- 2026-09-02
- Root cause
- Software design
- 510(k) numbers
- K231328, K193473, K132649, K210608, K233320, K253516, K262735, K150614, K210484, K190548, K251221, K211304, K212008, K240693, K201865, K160809, K143503, K221962, K170628, K200795, K230553, K230375, K162855, K200444, K160689, K171514, K223630, K132960, K261074, K252593
Product#
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
Reason for Recall#
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.