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Class 2 Device Recall Arial WaterResistant Pendant, model 59350 |
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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
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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
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For Additional Information Contact |
Gina L. Bennett 781-216-9035
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Manufacturer Reason for Recall |
Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
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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
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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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