Securitas Healthcare LLC
Lincoln, NE, US
Securitas Healthcare LLC appears in FDA device records in Lincoln, NE. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 32 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Securitas Healthcare LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Stanley Security Solutions, Inc.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1929691 | 1929691 | Securitas Healthcare LLC | 4600 Vine St, LINCOLN, NE 68503 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 32| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1032-2026 | Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3 | 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 | Open, Classified | |
| Z-1031-2026 | Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3 | 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 | Open, Classified | |
| Z-0570-2025 | 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 | Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System. | Class II | Open, Classified | |
| Z-2418-2024 | Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station. | This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery. | Class II | Open, Classified | |
| Z-2417-2024 | 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. | There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery. | Class II | Open, Classified | |
| Z-1943-2024 | 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. | The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts. | Class II | Open, Classified | |
| Z-0222-2024 | Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. | Class II | Open, Classified | |
| Z-0221-2024 | Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. | Class II | Open, Classified | |
| Z-0220-2024 | Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System. | Class II | Open, Classified | |
| Z-1250-2023 | 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. | The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices. | Class II | Open, Classified | |
| Z-0497-2022 | Senior Living Arial Emergency and Nurse Call Systems | Systems are not alarming due to increased memory consumption. | Class II | Open, Classified | |
| Z-1996-2019 | STANLEY Healthcare Arial 54315 Network Manager | STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial 54315 Serial-to-IP Network Gateway. | Class II | Terminated | |
| Z-1349-2019 | M200 Fall Monitoring System | Damaged capacitor on the printed circuit board. | Class II | Terminated | |
| Z-1499-2017 | Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button. | Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended. | Class II | Terminated | |
| Z-2492-2012 | Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. | The monitor may fail to sound an alarm | Class II | Terminated | |
| Z-2491-2012 | Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. | The monitor may fail to sound an alarm | Class II | Terminated | |
| Z-2490-2012 | Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. | The monitor may fail to sound an alarm | Class II | Terminated | |
| Z-2489-2012 | Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. | The monitor may fail to sound an alarm | Class II | Terminated | |
| Z-2488-2012 | Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. | The monitor may fail to sound an alarm | Class II | Terminated | |
| Z-1476-2012 | Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE. Product Usage: The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system. | Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system | Terminated | ||
| Z-1475-2012 | UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal Medical Products, Lincoln, NE. Designed to sound an alarm when a patient exceeds his or her safe range of movement from a wheelchair, chair, or bed. | Monitor gives false alarms | Terminated | ||
| Z-1947-2010 | Tabs Professional Monitor with Wire Bracket and Push Button Reset, Model 25223, Stanley Senior Technologies, Lincoln, NE. | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | Terminated | ||
| Z-1946-2010 | Tabs Professional Monitor Without Pull Cord or wall bracket, Model 25025, Stanley Senior Technologies, Lincoln, NE. | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | Terminated | ||
| Z-1945-2010 | Tabs Professional Monitor Without Wall Bracket, Model 25023. Stanley Senior Technologies, Lincoln, NE. | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | Terminated | ||
| Z-1944-2010 | Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Senior Technologies, Lincoln, NE. | Product might not indicate low battery alarms or exit alarms when powered by a DC power supply. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Securitas Healthcare LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain