FDA recall Z-0222-2024

Securitas Healthcare LLC · Class II · device

Product

Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm

Reason for recall

Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2023-09-25
Report date
2023-11-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2024