Events

Recall of Device Recall QuietCare

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
    61719
  • Event Risk Class
    Class 3
  • Event Number
    Z-1615-2012
  • Event Initiated Date
    2011-07-30
  • Event Date Posted
    2012-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108783
  • 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
    The quietcare production system experienced a partial outage on 7/29/11. as a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. the problem was identified and corrected and the unprocessed data was recovered and processed. however, because of the time lag in processing, a fe.
  • Action
    Initial notification to the affected facilities was done by telephone or email on 7/30/11. This was followed up with Urgent Field Notification letters to the customers on 8/12/11 via e-mail. For questions, customers were instructed to contact Customer Support at 1 (866) 772-8243.

Device

Device Recall QuietCare
  • Model / Serial
    Affected Serial Numbers: liqc.018778, liqc.020447, liqc.020428, liqc.024472, liqc.027039, liqc.024195, liqc.026718, liqc.023495, liqc.027065, liqc.024252, liqc.018722, liqc.024377, liqc.019808, liqc.017029, liqc.017310, liqc.026701, liqc.024190, liqc.019075, liqc.027351, liqc.023253, liqc.019497, liqc.019215, liqc.019217, liqc.017965, liqc.020530, liqc.024293, liqc.021530, liqc.026353, liqc.017900, liqc.019915, liqc.018447, liqc.021086, liqc.027072, liqc.023241, liqc.018169, liqc.017876, liqc.022049, liqc.026409, liqc.018126, liqc.019519,  liqc.017579, liqc.018271, liqc.017531, liqc.017532, liqc.018255, liqc.023888,  liqc.023340, liqc.023343, liqc.023342, liqc.018534, liqc.018536, liqc.018256,  liqc.017532, liqc.019582, liqc.021064, liqc.020981, liqc.021944, liqc.021764,  liqc.021284, liqc.017741, liqc.017738, liqc.024298, liqc.026760, liqc.027063, liqc.022321, liqc.022320, liqc.020843, liqc.022009, liqc.026620, liqc.026643,  liqc.026456, liqc.021428, liqc.021402, liqc.022054, liqc.019577, liqc.023782, liqc.023710, liqc.023708, liqc.019360, liqc.017682, liqc.021670, liqc.022983 (UK), liqc.022846 (UK).
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - USA and the United Kingdom.
  • Product Description
    QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is 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