Device recall

Z-0447-2022: Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module…

FDA device recall · Class II · Invacare Corporation

Key facts

Recall number (Z-number) Z-0447-2022
Recall event 89062
Product Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
Product code ITI
Recalling firm Invacare Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K202379
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)