Events

Recall of Device Recall HomeSafe AutoAlert Pendant, AAHB, or AutoAlert Fall Detector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lifeline Systems Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79010
  • Event Risk Class
    Class 2
  • Event Number
    Z-1316-2018
  • Event Initiated Date
    2017-11-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161078
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, communication, powered - Product Code ILQ
  • Reason
    A programing error in some model fd100 homesafe autoalert pendants will render the fall detection feature inoperable.
  • 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.

Device

Device Recall HomeSafe AutoAlert Pendant, AAHB, or AutoAlert Fall Detector
  • Model / Serial
    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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and Canada distribution
  • Product Description
    HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
  • Manufacturer
    Lifeline Systems Company

Manufacturer

Lifeline Systems Company
  • Manufacturer Address
    Lifeline Systems Company, 111 Lawrence St, Framingham MA 01702-8156
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA