Device recall

Z-1924-2025: Azure S DR MRI SureScan, Product number W3DR01

FDA device recall · Class II · Medtronic, Inc.

Key facts

Recall number (Z-number) Z-1924-2025
Recall event 96722
Product Azure S DR MRI SureScan, Product number W3DR01
Product code NVZ
Recalling firm Medtronic, Inc.
Recall class Class II
Status Open, Classified
PMA numbers P980035
FEI number 2182208

At a glance

  • None 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)