Events

Recall of Philips Lifeline

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

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
    53261
  • Event Risk Class
    Class 2
  • Event Number
    Z-0419-2010
  • Event Initiated Date
    2009-09-11
  • Event Date Posted
    2009-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85116
  • 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
    Pendant personal help button neck cord may not break away and if not will present a potential choking risk.
  • Action
    Philips Lifeline initiated Safety Notification letters on 9/21/09 to users and advised of the potential choking risk of the Pendant Personal Help Button The firm recommends that users consult their health care providers to determine which style of emergency button, including those that are worn on the wrist, is most beneficial for them. A postage-paid reply envelope had been provided. Questions should be addressed to Philips at 1-877-221-8756 (Monday  Friday, 8 a.m.  8 p.m. EST). Firm issued Press on 9/11/09. FDA Press issued 9/22/09

Device

Philips Lifeline
  • Model / Serial
    All serial numbers
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Canada
  • Product Description
    Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
  • Manufacturer
    Philips Lifeline Inc

Manufacturer

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