Events

Recall of QuietCareNetworked

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intel-GE Care Innovations LLC.

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
    65031
  • Event Risk Class
    Class 2
  • Event Number
    Z-1374-2013
  • Event Initiated Date
    2013-04-04
  • Event Date Posted
    2013-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117707
  • 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, environmental control, powered - Product Code IQA
  • Reason
    Customers at 4 facilities reported receiving duplicate alerts using the quietcare-networked product.
  • Action
    Care Innovations contacted their customers by phone and e-mail regarding the potential problems and fixes on April 4, 17, and 23, 2013. The information provided stated the product, problem, and actions to be taken by the customers. Contact Technical Support at 855-885-2273 for questions regarding this issue.

Device

QuietCareNetworked
  • Model / Serial
    QuietCare-Networked: Facility Server QC101601
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and Great Britain
  • Product Description
    QuietCare-Networked. || Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
  • Manufacturer
    Intel-GE Care Innovations LLC

Manufacturer

Intel-GE Care Innovations LLC
  • Manufacturer Address
    Intel-GE Care Innovations LLC, 3721 Douglas Blvd Ste 100, Roseville CA 95661-4243
  • Source
    USFDA