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Recall Observatory FDA recall evidence

Device product

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

Z-0222-2024

September 25, 2023

Class II

Product summary

Firm
Securitas Healthcare LLC
Event
Event 93188
Status
Ongoing
Classification
Class II
Quantity
49 devices
Official record key
device-enforcement:Z-0222-2024

Official wording

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

Code information: Manufacturing date codes: 23128 to 23251

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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