Events

Retiro De Equipo (Recall) de Device Recall E.CAM PHS Field of View Indicator Bars

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
    50773
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1505-2009
  • Fecha de inicio del evento
    2008-12-18
  • Fecha de publicación del evento
    2009-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77136
  • 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
    emmission tomography accessory - Product Code KPS
  • Causa
    Patient fingers can get pinched if they attempt to pull themselves up from the patient handling system without any assistance and grabbing onto the flip-up fov indicator bars.
  • Acción
    Siemens sent Urgent Field Correction Recall letters dated 12/18/08 to all users of the E.cam Systems. The accounts were informed of the potential risk to patients when they attempt to pull themselves up from the patient handling system (PHS) without any assistance and grabbing the field of view (FOV) indicator bar (aka flip-up armrests). The customers were advised to always assist the patient when getting on/off of the PHS. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective upgrade to the PHS with a modified FOV guide to mitigate the risk for patient injury free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance.

Device

Device Recall E.CAM PHS Field of View Indicator Bars
  • Modelo / Serial
    part number 43 66 618 (right) and 43 81 088 (left), serial numbers 00001 to 04031
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Guam, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey and United Arab Emirates.
  • Descripción del producto
    Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA