Device recall

Z-1369-2022: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1…

FDA device recall · Class III · Invacare Corporation

Key facts

Recall number (Z-number) Z-1369-2022
Recall event 90108
Product Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Product code CAW
Recalling firm Invacare Corporation
Recall class Class III
Status Open, Classified
510(k) numbers K203210
FEI number 1525712

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)