Medical device recalls Moderate risk

Lifeline Systems Company recalls HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.

Recall date
November 13, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1316-2018
FDA classification
Class II
Brand / firm
Lifeline Systems Company
Sold / distributed
US and Canada distribution

Why it was recalled

A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.

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

What was recalled

HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.

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