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U.S. Department of Health and Human Services

Class 2 Device Recall HomeSafe AutoAlert Pendant, AAHB, or AutoAlert Fall Detector

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 Class 2 Device Recall HomeSafe AutoAlert Pendant, AAHB, or AutoAlert Fall Detectorsee related information
Date Initiated by FirmNovember 13, 2017
Create DateApril 06, 2018
Recall Status1 Terminated 3 on May 16, 2019
Recall NumberZ-1316-2018
Recall Event ID 79010
510(K)NumberK914103 
Product Classification System, communication, powered - Product Code ILQ
ProductHomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
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. 
FEI Number 1000086682
Recalling Firm/
Manufacturer		 Lifeline Systems Company
111 Lawrence St
Framingham MA 01702-8156
For Additional Information ContactJanina Sadlowski,
508-988-1780
Manufacturer Reason
for Recall		A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionFirm 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 Commerce20201
DistributionUS and Canada distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ILQ
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