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Recall Observatory FDA recall evidence

Device product

Senior Living Arial Emergency and Nurse Call Systems

Z-0497-2022

November 17, 2021

Class II

Product summary

Firm
Stanley Security Solutions Inc
Event
Event 89181
Status
Ongoing
Classification
Class II
Quantity
11 units (systems)
Official record key
device-enforcement:Z-0497-2022

Official wording

Reason: Systems are not alarming due to increased memory consumption.

Code information: 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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Systems are not alarming due to increased memory consumption.