| Date Initiated by Firm |
February 06, 2023 |
| Date Posted |
March 14, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1250-2023 |
| Recall Event ID |
91625 |
| Product Classification |
System, environmental control, powered - Product Code IQA
|
| Product |
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. |
| Code Information |
v11.0.0.2 downloaded from the Google Play Store on or after 1/14/2023, UDI (01)00840948102769(10)110026. |
Recalling Firm/
Manufacturer |
Securitas Healthcare LLC
4600 Vine St
Lincoln NE 68503-2823
|
| For Additional Information Contact |
Ameya Oke
812-371-7115
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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 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. |
| Quantity in Commerce |
Approximately 350 downloads |
| Distribution |
Worldwide distribution - US Nationwide and the country of Canada. |
| Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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