Securitas Healthcare LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1031-2026 | Class II | Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3 | December 8, 2025 |
| Z-1032-2026 | Class II | Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3 | December 8, 2025 |
| Z-0570-2025 | Class II | Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobil | November 1, 2024 |
| Z-2418-2024 | Class II | Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station. | June 20, 2024 |
| Z-2417-2024 | Class II | Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device i | June 20, 2024 |
| Z-1943-2024 | Class II | Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 a | April 11, 2024 |
| Z-0221-2024 | Class II | Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm | September 25, 2023 |
| Z-0222-2024 | Class II | Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient ala | September 25, 2023 |
| Z-0220-2024 | Class II | Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm | September 25, 2023 |
| Z-1250-2023 | Class II | Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Pla | February 6, 2023 |