Z-1316-2018Class II

HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator

Name: Z-1316-2018 HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator
Creator: Lifeline Systems Company
Published: 2017-11-13
License: https://open.fda.gov/license/

Lifeline Systems, Inc. / initiated 2017-11-13 / Terminated / root cause: software

FDA source

Lifeline Systems Company began a recall of HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator on 2017-11-13. FDA classified it as Class II and gives the reason as "A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1316-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-13
Posted: 2018-04-06
Terminated: 2019-05-16
Recalling firm: Lifeline Systems, Inc.
Product: HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Product code: ILQ System, Communication, Powered
Reason for recall: A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Firm has contacted all recipients and informed them of an issue that affects Philips Lifeline AutoAlert help button from automatically signaling the Lifeline Response Center for help in the event of a fall. Further instructed them that they would need to press the Lifeline Help Button in order to connect with the emergency response center. They then instruct them to return their inventory for replacement. New AAHB Replacements will be provided when available. Philips will work with the Programs to ensure buttons swaps are completed.
Quantity in commerce: 20201
Distribution: US and Canada distribution
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1316-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1316-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-06

Product code ILQ

K914103Class IILifeline(r) Personal Response SystemLifeline Systems, Inc. / cleared 1991-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)