Recall Record

Framingham, MA, United States

Lifeline Systems Company recalls

1 recall recorded since 2018, most recently on 13 November 2017. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
13 November 2017
Terminated
16 May 2019
Reason
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
Distribution
US and Canada distribution
Initiated
Voluntary: Firm initiated
Recall number
Z-1316-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.