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Open, Classified

Senior Living Arial Emergency and Nurse Call Systems

FDA Recall Z-0497-2022 · Posted None

Recall StatusOpen, Classified
Product CodeIQA
Date Initiated2021-11-17
Product Quantity11 units (systems)

Reason for Recall

Systems are not alarming due to increased memory consumption.

Firm 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].

Root Cause

Component design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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