Events

Retiro De Equipo (Recall) de Device Recall Proteus XR/a

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 Healthcare, LLC.

¿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
    70063
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0954-2015
  • Fecha de inicio del evento
    2014-12-08
  • Fecha de publicación del evento
    2015-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132198
  • 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
    System, x-ray, stationary - Product Code KPR
  • Causa
    Ge healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of proteus xr/a x-ray imaging systems. no injuries reported.
  • Acción
    Consignees were sent on 12/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 17107, dated December 8, 2014. The letter was addressed to Hospital Administrators /Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact information (For questions in USA call 800-437-1171, For other countries contact your local GE Healthcare Service Representative.

Device

Device Recall Proteus XR/a
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.
  • Descripción del producto
    GE Healthcare, Proteus XR/a. || Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA