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U.S. Department of Health and Human Services

Class 2 Device Recall Arial WaterResistant Pendant, model 59350

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  Class 2 Device Recall Arial WaterResistant Pendant, model 59350 see related information
Date Initiated by Firm June 22, 2016
Create Date March 20, 2017
Recall Status1 Terminated 3 on November 20, 2017
Recall Number Z-1499-2017
Recall Event ID 76047
Product Classification System, communication, powered - Product Code ILQ
Product Arial Wireless Water-Resistant Call Pendant
The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
Code Information Serial numbers WP149149 through WP149398 and WP149649 through WP149898.
Recalling Firm/
Manufacturer		 Stanley Security Solutions Inc
4600 Vine St
Lincoln NE 68503-2823
For Additional Information Contact Gina L. Bennett
781-216-9035
Manufacturer Reason
for Recall		 Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Stanley Healthcare sent an Important Recall Notice dated June 22, 2016, to all affected customers. The notice instructed customers to discontinue use of the device and to contact the recalling firm to arrange for return of the device. The recalling firm also asked the customer to complete a response form indicating they read, understood and complied with the recall notice. Customers with questions were instructed to contact Arial Customer Service at 888-716-0077. For questions regarding this recall call 781-216-9035.
Quantity in Commerce 500 individual pendants
Distribution Nationwide Distribution to AR, AZ, CA, FL, GA, IA, ID, IN, KS, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SD, UT, VA, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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