CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
Arial Server recalled by Securitas Healthcare
Securitas Healthcare is recalling Arial Server, distributed nationwide in the US. The recall was initiated on 1 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0570-2025
- FDA event ID
- 95652
- Recalling firm
- Securitas Healthcare, Lincoln, NE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2024
- FDA classified
- 27 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 1 Nov 2024 | Recall initiated by company | |
| 27 Nov 2024 | Classified by FDA | +26 days |
| 4 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.
Questions about this recall
Why was it recalled?
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
Which lots are affected?
All Systems using Arial Server Software versions 11.1.4 through 11.1.6 in conjunction with the Arial Mobile Application or Arial Care Giver Application
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Securitas Healthcare
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Arial 900 MHz Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Arial Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | 13 states |
| Device | CLASS II | Arial Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | 9 states |
| Device | CLASS II | Arial mobile application recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Arial Water Resistant Pendant with Neck Lanyard recalled | Securitas Healthcare | Device Malfunction | Nationwide |
Other Medical Software recalls
All 932| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |