FDA recall Z-1250-2023

Securitas Healthcare LLC · Class II · device

Product

Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.

Reason for recall

The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2023-02-06
Report date
2023-03-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2023