Recall Z-1032-2026— Securitas Healthcare LLC
Class II · Ongoing
Class II FDA medical device recall by Securitas Healthcare LLC, initiated 2025-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3. Reason: 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 a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing..
- Recalling firm
- Securitas Healthcare LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-08
- Firm location
- Lincoln, NE, United States
Product description
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Reason for recall
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 a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.