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Recall Observatory FDA recall evidence

Device product

Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.

Z-2417-2024

June 20, 2024

Class II

Product summary

Firm
Securitas Healthcare LLC
Event
Event 94878
Status
Ongoing
Classification
Class II
Quantity
1268 units
Official record key
device-enforcement:Z-2417-2024

Official wording

Reason: There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.

Code information: All units of the Affected Device Models sold between July 26, 2022 and June 5, 2024

Distribution pattern: US: NE, MN, WA, MD, TX, ON, WI, OR, MS, CA, and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.