Lifeline Systems Company: Medical Device Recall in 2018 - (Recall #: Z-1316-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 13, 2017

Date Posted: April 18, 2018

Recall Number: Z-1316-2018

Event ID: 79010

Reason for Recall:

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

Status: Terminated

Product Quantity: 20201

Code Information:

Model FD100 HomeSafe AutoAlert Pendants with Reference Number 300000219841 and 300000219851 All materials with R and UR prefixes remanufactured between 07-28 -2017 and 1 1-06-20 17; 100% of this material (UDI) are affected.

Distribution Pattern:

US and Canada distribution

Voluntary or Mandated:

Voluntary: Firm initiated