Retiro De Equipo (Recall) de Device Recall MRI

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, 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
    77488
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3027-2017
  • Fecha de inicio del evento
    2017-05-11
  • Fecha de publicación del evento
    2017-08-02
  • Estado del evento
    Completed
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Possible incorrect wiring of the uninterruptable power supply, which could contribute to a potential shock hazard.
  • Acción
    Consignees received a written recall notice dated 05/17/2017 notifying them of a correction to all units using an Uninterruptable Power Supply. Consignees were instructed not to unplug the unit and to continue normal use. Units with the Eaton 9130 Uninterruptable Power Supply connected to the MR operator console would receive a correction at no charge. This would involve possibly replacing the power cable. GE Representatives will be contacting consignees to arrange corrections. Any questions can be directed to GE Healthcare Service at 1-800-437-1171 or your local service representative.

Device

  • Modelo / Serial
    Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
  • Descripción del producto
    Signa PET/MR (K163619, K142098) || Product Usage: || The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    GE Medical Systems, LLC, 3200 N Grandview Blvd, Waukesha WI 53188-1693
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA