Recall Z-1250-2023 ยท IQA System, Environmental Control, Powered
Securitas Healthcare LLC
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.
| Date | Mar 14, 2023 (initiated Feb 6, 2023) |
| Status | Open, Classified |
| Reason | The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 1/24/2023 on 2/6/2023 via certified mail to the potentially impacted clients. The letters described the issue and informed the client this only applies to those versions of Arial Mobile Application v11.0.0.2 for Android devices downloaded from the Google Play Store and does not apply to versions received directly from Securitas Healthcare. It also does not apply to mobile devices with an iOS operating system. The letter explains that the client will be unable to use the Arial Mobile Application and will not receive or be able to view and respond to |
| Quantity | Approximately 350 downloads |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.