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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.

FDA Recall Z-1499-2017 · Posted None

Recall StatusTerminated
Product CodeILQ
Date Initiated2016-06-22
Date Terminated2017-11-20
Product Quantity500 individual pendants

Reason for Recall

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

Firm 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.

Root Cause

Software design (manufacturing process)

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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