HomeSafe AutoAlert Pendant Cl II

Company:Lifeline Systems Company.
Date of Enforcement Report 4/18/2018
Class lI:

PRODUCT

HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Recall Number Z-1316-2018

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

RECALLING FIRM/MANUFACTURER
Lifeline Systems Company, Framingham, MA on 11/13/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20201

DISTRIBUTION
US and Canada

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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