Medical Device
Manufacturing
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Z-0497-2022Class II

Senior Living Arial Emergency and Nurse Call Systems

Securitas Healthcare LLC / initiated 2021-11-17 / Open, Classified / root cause: design

Stanley Security Solutions Inc began a recall of Senior Living Arial Emergency and Nurse Call Systems on . FDA classified it as Class II and gives the reason as "Systems are not alarming due to increased memory consumption". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-0497-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Securitas Healthcare LLC
Product
Senior Living Arial Emergency and Nurse Call Systems
Product code
IQA System, Environmental Control, Powered
Reason for recall
Systems are not alarming due to increased memory consumption.
Root cause tag
design
FDA root cause
Component design/selection
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].
Quantity in commerce
11 units (systems)
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 codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0497-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0497-2022Class IIOngoingVoluntary: Firm initiated