Events

Recall of Device Recall Care Innovations QuietCareNetworked product

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
    63957
  • Event Risk Class
    Class 2
  • Event Number
    Z-0877-2013
  • Event Initiated Date
    2012-12-16
  • Event Date Posted
    2013-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115109
  • 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
    Monitor, bed patient - Product Code KMI
  • Reason
    Care innovations detected a software anomaly: during the engineering investigation into the cause of why a wander alert was not generated, a defect in the implementation of the wander and night motion adls was discovered.
  • Action
    Care Innovations sent a "DEVICE CORRECTION NOTIFICATION" letter dated 12/20/12 to all affected customers. The letter identified the product and problem. Correction was performed remotely by the firm. Contact the firm at 917-232-4775 for questions regarding this notice.

Device

Device Recall Care Innovations QuietCareNetworked product
  • Model / Serial
    All units of this model.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    QuietCare-Networked product, Facility Server/model: QC101601; || The QuietCare system is intended to detect and analyze residents' movements.
  • 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