Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of t

FDA device recall Z-1250-2023 · posted 2023-03-14 · Open, Classified

Recall details

Recalling firm

Securitas Healthcare LLC

Reason for recall

The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices.

Action taken

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 notifications and system warnings on their Android devices. For the clients who have already upgraded their Android devices to Arial Mobile Application v11.0.0.2 for Android from the Google Play Store, they are to contact the Securitas Healthcare Technical Support Team for instructions on how to obtain and install a working version of the application for Android devices. In the interim, they are to use the Arial Server or Arial Web Client to view and respond to notifications and system warnings. For clients who have not yet updated to the affected version, they may continue to use the previous unaffected version. They are instructed: (1) to not download or upgrade to the affected version from the Google Play store; (2) set the Mobile Device Management package to not push Arial Mobile Application v11.0.0.2 updates automatically; (3) inform staff and caregivers not to download or install the affected version; and (4) to disable automatic updates on their Android devices. All clients are to disseminate the notice to all affected areas within their facility and satellite facilities which may be using the mobile application and the clients are to complete the attached response form, even if their facility does not use the mobile application. The response form indicates whether or not the facility uses this application and has notified all affected parties.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

IQA

Quantity affected

Approximately 350 downloads

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2023-02-06

Date posted

2023-03-14

Location

Lincoln, NE