10 results
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52ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·December 4, 2024
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·July 31, 2024
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·July 31, 2024
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·June 12, 2024
Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·November 15, 2023
Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·November 15, 2023
Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·November 15, 2023
Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·March 22, 2023