Recall Z-1499-2017 ยท ILQ System, Communication, Powered
Stanley Security Solutions Inc
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.
| Date | Jun 22, 2016 |
| Status | Terminated |
| Reason | Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.