Events

Retiro De Equipo (Recall) de Device Recall Siemens MAGNETOM systems

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 Siemens Medical Solutions USA, Inc.

¿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
    70712
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1308-2015
  • Fecha de inicio del evento
    2015-03-09
  • Fecha de publicación del evento
    2015-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134534
  • 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
    The gradient output supervision was permanently turned off on the magnetom system, meaning that gradient outputs could exceed iec60601-2-33 limits and peripheral nerve stimulation could occur.
  • Acción
    A Customer Safety Advisory Notice, dated March 6, 2015, was sent to end users to inform them of the potential issue and what measures were being taken to mitigate possible risks.

Device

Device Recall Siemens MAGNETOM systems
  • Modelo / Serial
    model numbers: 10432914, 10432915, 10684331, 10684332, 10684333, 10684334 with serial numbers:  45398 45788 59092 60099 41953 45805 52255 45812 52250 52171 52264 41980 41448 60092 41727 60038 60062 59071 59065 60061 60082 62032 41548 52168 59032 62014 60086 57118 52108 41628 60070 45249 62027 41699 41701 59090 60060 60052 41903 52082 41473 45537 41749 41457 42060 41383 41769 45778 62018 45628 52200 42033 52135 52195 41317 41529 45371 57060 41862 59101 52150 52240 52128 41608 41624 42012 45160 45387 45603 45526 41476 45155 52251 41746 62020 41503 59120 62024 59096 62025 41897 59109 45681 41362 60053 60055 59087 60085 41819 59116 62031 52172 52057 52153 45623 59112 41844 41874 59104 45850 41621 52192 60054 41595 45667 41353 60063 57254 41556 60079 45408 41654 52021 52072 57146 45239 59035 59076 41629 41802 41952 45230 45251 41979 45237 45205 45694 41671 45507 41389 41295 60091
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA