Events

Retiro De Equipo (Recall) de Device Recall GE Discovery NM 630

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
    60790
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1111-2012
  • Fecha de inicio del evento
    2012-01-11
  • Fecha de publicación del evento
    2012-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106480
  • 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, tomography, computed, emission - Product Code KPS
  • Causa
    Ge healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your discovery nm/ct 670 and/or discovery nm 630 system that may impact operator safety. 1. the cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. 2. another issue is that the.
  • Acción
    The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated January 13, 2012 to its Consignees/Customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The customers were instructed to continue to use product, ensure that the collimator exchange monitor the collimator cart are properly locked in place; pay attention to any unexpected cart motion during the exchange procedure; cease the process immediately if the cart has moved from the docking spot, dock cart in place again, and complete the exchange; and if a 3rd party service engineer is servicing rather than the firm, GE, advise according to the instructions in letter. A GE Healthcare Service representative will perform the required hardware update on each affected system. If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.

Device

Device Recall GE Discovery NM 630
  • Modelo / Serial
    22002 22017 22018 22015 22009 22008 22005 22001 22014 22003
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: CA, FL, GA, IL, NJ, NY, NC, TX, and WI; and countries of: AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, FRANCE, GERMANY, INDIA, ISRAEL, ITALY, KOREA, JAPAN, NETHERLANDS, NORWAY, POLAND, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, UNITED KINGDOM.
  • Descripción del producto
    GE Discovery NM 630 || The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
  • 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