Events

Recall of Device Recall CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems Information Tecnology.

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
    51253
  • Event Risk Class
    Class 2
  • Event Number
    Z-1232-2009
  • Event Initiated Date
    2009-02-27
  • Event Date Posted
    2009-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79458
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Reason
    Ge healthcare is aware of potential network time issues associated with the time change aspects of certain carescape cic pro" software versions. these issues may impact patient safety. no reported patient injuries or illnesses for the use of this device in conjunction with this device correction.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated February 27, 2009. The letter was addressed to the Chief of Nursing/Chief of Biomedical Engineering and Risk Manager/Healthcare Administrator. The letter describes the Safety Issue, Affected Product Details, Safety instructions, Product Correction, and Contact Information. Direct questions to your local GE Healthcare Field Service Representative or the GE Healthcare Technologies Support Center by calling 1-800-558-7044 (Option 2, Technical Support).

Device

Device Recall CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including US (states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, PR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WY, WI, and WV) and countries of UNITED ARAB EMIRATES, AUSTRIA, AUSTRALIA, BOSNIA AND HERZEGOVINA, BANGLADESH, BELGIUM, BRAZIL, BAHAMAS, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CUBA, CYPRUS, CZECH REPUBLIC, GERMANY, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, GHANA, GREECE, HONG KONG, HUNGARY, HONDURAS, INDONESIA, IRELAND, ISRAEL, INDIA, IRAQ, BRITISH INDIAN OCEAN TERRITORY, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, MALTA, MEXICO, MALAYSIA, NIGERIA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, PANAMA, PERU, PHILIPPINES, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SW DEN, SINGAPORE, SLOVENIA, SLOVAK REPUBLIC, SYRIA, THAILAND, TURKEY, TRINIAD, TOBAGO, TAIWAN, UKRAINE, UNITED KINGDOM, VENEZUELA, YEMEN, and SOUTH AFRICA.
  • Product Description
    GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. || The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server.
  • Manufacturer
    GE Medical Systems Information Tecnology

Manufacturer

GE Medical Systems Information Tecnology
  • Manufacturer Address
    GE Medical Systems Information Tecnology, 9900 Inovation Drive, RP 2122 3rd Floor, Wauwatosa WI 53226
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA