Summary
The FDA issued a Class II for Senior Living Arial Emergency and Nurse Call Systems by Stanley Security Solutions Inc. Reason: Systems are not alarming due to increased memory consumption..
Details
Source
Device Recall
External ID
Z-0497-2022
Action Date
2022-01-26
Status
Ongoing
Category
device
Product Description
Senior Living Arial Emergency and Nurse Call Systems
Lot/Code Info: 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
Quantity Affected: 11 units (systems)
Reason for Recall
Systems are not alarming due to increased memory consumption.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, MD, MI, MN, SD, TN, and WA. The countries of Canada and Qatar.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-17
Company
Lincoln, NE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stanley Security Solutions Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stanley Security Solutions Inc have FDA actions?
This is the only FDA action we have on record for Stanley Security Solutions Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0497-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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