RegWardenFDA facility compliance records
Company

Securitas Healthcare LLC.

7 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2023: 2 recalls; 2024: 4 recalls; 2025: 1 recalls2017201820192020202120222202342024120252026
  • Recalls (7)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-12-08
    Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit …
  • Class IIOngoing2024-11-01
    Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
  • Class IIOngoing2024-06-20
    There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.
  • Class IIOngoing2024-06-20
    This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.
  • Class IIOngoing2024-04-11
    The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, …
  • Class IIOngoing2023-09-25
    Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
  • Class IIOngoing2023-02-06
    The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Securitas Healthcare LLC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10023544-securitas-healthcare-llc/

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