Device recall

Z-1138-2015: FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power…

FDA device recall · Class II · Invacare Corporation

Key facts

Recall number (Z-number) Z-1138-2015
Recall event 69378
Product FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Product code ITI
Recalling firm Invacare Corporation
Recall class Class II
Status Terminated
Termination date Sep 23, 2015
510(k) numbers K991168
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)