Recall Z-0004-2016— Lifeline Systems, Incorporated

Name: FDA recall Z-0004-2016
Creator: U.S. Food and Drug Administration
Published: 2015-07-23

Class II · Terminated

Class II FDA medical device recall by Lifeline Systems, Incorporated, initiated 2015-07-23, terminated 2020-11-10. It names one FDA 510(k) clearance: K914103. Product: Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.. Reason: Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging..

Recalling firm: Lifeline Systems, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2015-07-23
Terminated: 2020-11-10
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

Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

Reason for recall

Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.

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