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Recall Observatory FDA recall evidence

Device 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.

Z-1499-2017

June 22, 2016

Class II

Product summary

Firm
Stanley Security Solutions Inc
Event
Event 76047
Status
Terminated
Classification
Class II
Quantity
500 individual pendants
Official record key
device-enforcement:Z-1499-2017

Official wording

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

Code information: Serial numbers WP149149 through WP149398 and WP149649 through WP149898.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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