Device recall

Z-0155-2024: SOZO Bilateral Arm L-Dex Software

FDA device recall · Class II · Impedimed Limited

Key facts

Recall number (Z-number) Z-0155-2024
Recall event 92943
Product SOZO Bilateral Arm L-Dex Software
Product code OBH
Recalling firm Impedimed Limited
Recall class Class II
Status Open, Classified
510(k) numbers K180126
FEI number 3004782476

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)