Medical device recalls Moderate risk

Stanley Security Solutions Inc recalls Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call manageme…

Recall date
June 22, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1499-2017
FDA classification
Class II
Brand / firm
Stanley Security Solutions Inc
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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