FDA Recall Open, Classified

Senior Living Arial Emergency and Nurse Call Systems

Recall: Z-0497-2022 · Initiated November 17, 2021

Recall

Recall Number
Z-0497-2022
Event Number
89181
Firm
Stanley Security Solutions Inc
FEI Number
1929691
Product Code
IQA
Status
Open, Classified
Root Cause
Component design/selection
Initiated
November 17, 2021
Address
4600 Vine St, Lincoln, NE, 68503-2823

Description

Senior Living Arial Emergency and Nurse Call Systems

Reason

Systems are not alarming due to increased memory consumption.

Action

The firm distributed a notice titled "Voluntary Market Withdrawal of Dell Optiplex 3070/3080 Servers" informing customers of an issue with Arial Call Systems outfitted with any Dell 3070/3080 servers, resulting in failure of alarm. The firm asked that customers facilitate the replacement of the Dell 3070/3080 server components through a service technician. Customers with any questions were directed to contact Mr. Garth Jack at (402)742-9335. A second notice from the firm titled "Urgent: Field Safety Notice Adisory Regarding Use of Dell Optiplex 3070/3080 Servers with Stanley Healthcare Arial Emergency and Nurse Call Systems," dated 12/17/2021 was sent to customers by certified mail. Customers who own an Arial Call System and did not purchase a Dell 3070/3080 server from Stanley but utilize one with their system need to discontinue use and replace the server as soon as possible. Customers who purchased a Dell 3070/3080 server used in conjunction with the Arial Call system were informed that a representative from Stanley will be reaching out to coordinate the replacement of the server at no cost. Replacement servers will be shipped to customers, but their replacement needs to be conducted by a Stanley representative, so they are to be safely stored until this can be coordinated. Dell 3070/3080 servers removed following correction need to be returned to Stanley Healthcare using a provided RMA number, along with a completed Certification of Products Returned form that will be provided. The firm asks that the Field Safety Notice be distributed within organizations with affected product. Customers with any questions are to contact Mr. Garth Jack at (402)742-9335 or by email at [email protected].

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, MD, MI, MN, SD, TN, and WA. The countries of Canada and Qatar.

Quantity

11 units (systems)