Device recall

Z-2048-2026: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE…

FDA device recall · Class II · Boston Scientific Corporation

Key facts

Recall number (Z-number) Z-2048-2026
Recall event 98679
Product LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Product code MXD
Recalling firm Boston Scientific Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K231328
FEI number 2124215

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)