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Recall Observatory FDA recall evidence

Device product

Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.

Z-2418-2024

June 20, 2024

Class II

Product summary

Firm
Securitas Healthcare LLC
Event
Event 94882
Status
Ongoing
Classification
Class II
Quantity
77 units
Official record key
device-enforcement:Z-2418-2024

Official wording

Reason: This is a risk that alarms will not be received by the Arial Wireless Nurse 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: FL, CA, AL, ND, MS, WA, MN, TX, OR, WI, MD, NY, NE

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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