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U.S. Department of Health and Human Services

Class 2 Device Recall Arial Call Stations

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 Class 2 Device Recall Arial Call Stationssee related information
Date Initiated by FirmOctober 12, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0438-2027
Recall Event ID 99965
Product Classification Fall prevention alarm/sensor combination attached or unattached - Product Code PJO
ProductArial Call Stations Model/Catalog Number: CSK200-900, CSK200-900MR, CSK200, CSK200MR, CSK200-1069, CSK200-1069MR Software Version: V1.6.4 (FW)
Code Information UDI-DIs: CSK200-1069MR: 00840948102707 CSK200-1069: 00840948102691 CSK200-MR: 00840948102684 CSK200: 00840948102677 CSK200-900MR: 00840948102660 CSK200-900: 00840948102653 Software Version: V1.6.4 (FW)
FEI Number 1929691
Recalling Firm/
Manufacturer		 Securitas Healthcare LLC
4600 Vine St
Lincoln NE 68503-2823
For Additional Information ContactAmeya Oke
1-812-3717115
Manufacturer Reason
for Recall		Call station batteries may fully deplete without a low battery alert.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 12, 2026, the firm posted the notification to their website at https://www.securitashealthcare.com/product-advisories. The firm sent letters to customers on 10/22/2026. Customers were instructed on the following: 1. If you have Panasonic or have installed other non-approved batteries in your call stations, or have Panasonic or non-approved batteries in inventory for future use, replace them with Duracell, Jauch, or GP CR123 size batteries 2. Reduce the Missing Device Timeout setting to 125 minutes. This may provide earlier notification of a call station with a depleted battery on some Arial systems. Refer to Appendix 1 for instructions. 3. Regularly monitor alerts and battery status. "Missing Device" alerts should be promptly investigated. 4. Implement supplemental measures for high-risk residents to reduce the potential impact of an undetected battery depletion event.
Quantity in Commerce42781
DistributionDistribution US nationwide, Canada, Israel, Republic of Korea, and United Arab Emirates.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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