FDA recall Z-1316-2018

Product

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

Reason for recall

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

Distribution

US and Canada distribution

Key facts

Status

Terminated

Initiation date

2017-11-13

Report date

2018-04-18

Termination date

2019-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Framingham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2018