Device recall: Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Class II FDA enforcement event 98122. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Securitas Healthcare LLC started this device recall on 8 Dec 2025. The firm address in the FDA record is in Lincoln, NE. FDA put the recall in Class II. FDA event 98122 has 2 product records. The first FDA enforcement report date is 14 Jan 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution -US Nationwide and the country of Canada.
Recalling firm
Securitas Healthcare LLC, Lincoln, NE.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1031-2026 | Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3 | 5627 units | Class II | Ongoing | 14 Jan 2026 |
| Z-1032-2026 | Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3 | 1898 units | Class II | Ongoing | 14 Jan 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Nov 2024 | Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Ari | Device | Class II | 1 |
| 20 Jun 2024 | Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station. | Device | Class II | 1 |
| 20 Jun 2024 | Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resi | Device | Class II | 1 |
| 11 Apr 2024 | Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a | Device | Class II | 1 |
| 25 Sep 2023 | Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm | Device | Class II | 3 |
| 6 Feb 2023 | Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of t | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1031-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 98122. https://recallregister.com/fda/ii/98122/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution -US Nationwide and the country of Canada.
- What quantity of product is in FDA event 98122?
- The event has 2 product records. The first record gives this quantity:
5627 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.