Device recall

Z-1943-2024: Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that…

FDA device recall · Class II · Securitas Healthcare LLC

Key facts

Recall number (Z-number) Z-1943-2024
Recall event 94607
Product Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.
Product code IQA
Recalling firm Securitas Healthcare LLC
Recall class Class II
Status Open, Classified
FEI number 1929691

At a glance

  • None 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)