FDA Recall Terminated

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.

Recall: Z-1499-2017 · Initiated June 22, 2016

Recall

Recall Number
Z-1499-2017
Event Number
76047
Firm
Stanley Security Solutions Inc
FEI Number
1929691
Product Code
ILQ
Status
Terminated
Root Cause
Software design (manufacturing process)
Initiated
June 22, 2016
Terminated
November 20, 2017
Address
4600 Vine St, Lincoln, NE, 68503-2823

Description

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.

Reason

Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.

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.

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.

Quantity

500 individual pendants