Events

Retiro De Equipo (Recall) de Device Recall CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Medical Systems Information Tecnology.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    51253
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1232-2009
  • Fecha de inicio del evento
    2009-02-27
  • Fecha de publicación del evento
    2009-05-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79458
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Detector and alarm, arrhythmia - Product Code DSI
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    GE Medical Systems Information Tecnology, 9900 Inovation Drive, RP 2122 3rd Floor, Wauwatosa WI 53226
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA