Events

Recall of Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems Information Technologies, 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
    78918
  • Event Risk Class
    Class 2
  • Event Number
    Z-0487-2018
  • Event Initiated Date
    2018-01-11
  • Event Date Posted
    2018-01-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160858
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Reason
    Carescape central station (cscs) software version 2.0.2 units may experience unexpected no comm (no communication) and network communication issues after boot-up or system restart.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and email to its consignees on 01/11/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions and follow the safety instructions. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044 or your local Service Representative.

Device

Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS)
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Algeria, Australia, Austria, Canada, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
  • Product Description
    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 || The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.
  • Manufacturer
    GE Medical Systems Information Technologies, Inc.

Manufacturer

GE Medical Systems Information Technologies, Inc.
  • Manufacturer Address
    GE Medical Systems Information Technologies, Inc., 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA