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Arial recallZ-0497-2022 · Stanley Security Solutions Inc · initiated Nov 17, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stanley Security Solutions Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Systems are not alarming due to increased memory consumption.

FDA root cause category: Component design/selection

What the company is doing

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].

Recall details

Recall number
Z-0497-2022
Status
Open, Classified
Initiated by the company
Nov 17, 2021
Recalling firm
Stanley Security Solutions Inc
Quantity
11 units (systems)
Product code
IQA
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, MD, MI, MN, SD, TN, and WA. The countries of Canada and Qatar.

Product description

Senior Living Arial Emergency and Nurse Call Systems

Code information (models, lots, serial numbers)

Model No. 0900-989; Lot No.: 7VQYZB3, G1GG8B3, 1TX2613, 7VQWZB3, GRRT243, 1TX3613, G1H58B3, HJP7N23, HJP9N23, 51SDR33, and GRRV243; UDI No.: (01)00840948100987(21)7VQYZB3, (01)00840948100987(21)1TX2613, (01)00840948100987(21)7VQZZB3, (01)00840948100987(21)GRRT243, (01)00840948100987(21)G1GF8B3, (01)00840948100987(21)1TX3613, (01)00840948100987(21)G1H58B3, (01)00840948100987(21)HJP7N23, (01)00840948100987(21)HJP9N23, (01)00840948100987(21)51SDR33, (01)00840948100987(21)GRRV243

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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