Device recall

Z-1224-2022: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

FDA device recall · Class II · Medtronic Xomed, Inc.

Key facts

Recall number (Z-number) Z-1224-2022
Recall event 90163
Product NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Product code GWF
Recalling firm Medtronic Xomed, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K200759
FEI number 1045254

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)