Events

Recall of Philips GoSafe Communicator 7000L

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

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
    71208
  • Event Risk Class
    Class 2
  • Event Number
    Z-1987-2015
  • Event Initiated Date
    2015-04-22
  • Event Date Posted
    2015-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136576
  • 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
    Home communicator model 7000l may not sense the phone line under certain unusual landline phone conditions.
  • Action
    Philips Lifeline notified all consignees of the recall via phone starting on April 22, 2015. The call informs consignees of the issue and actions to be taken. For questions, consignees can contact customer service at 1-800-451-0525 ext. 1608. Consignees were also sent a letter to all consignees instructing them that Lifeline would send out a qualified Installiation Representative for an equipment exchange.

Device

Philips GoSafe Communicator 7000L
  • Model / Serial
    Serial Numbers: 9030003931 9030001761 9030002025 9030002242 9030001588 9030000853 9030001696 9030003178 9030003086 9030000589 9030001526 9030003837 9030000681 9030003507 9030000600 9030001060 9030001517 9030004154 9030002875
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AK AZ CA CT FL IA IL KY MA MD MT NC NE NH NY OH OR SC VA WA and WI.
  • Product Description
    Philips GoSafe Communicator 7000L || Personal emergency response system.
  • Manufacturer
    Lifeline Systems, Incorporated

Manufacturer

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