Recall Z-1316-2018— Lifeline Systems Company

Name: FDA recall Z-1316-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-13

Class II · Terminated

Class II FDA medical device recall by Lifeline Systems Company, initiated 2017-11-13, terminated 2019-05-16. It names one FDA 510(k) clearance: K914103. Product: HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.. Reason: A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable..

Recalling firm: Lifeline Systems Company
Classification: Class II
Status: Terminated
Initiated: 2017-11-13
Terminated: 2019-05-16
Firm location: Framingham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K914103 — LIFELINE(R) PERSONAL RESPONSE SYSTEMLifeline Systems, Inc.·cleared 1991-09-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.