Events

Retiro De Equipo (Recall) de Device Recall Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license

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
    70020
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0994-2015
  • Fecha de inicio del evento
    2014-12-15
  • Fecha de publicación del evento
    2015-01-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132119
  • 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
    Potential for composed images to be flipped before being sent to pacs on systems with software version ve10 and smartortho license. flipped images may be reversed so the associated annotations, e.G. labels (r/l), may be displayed incorrectly, potentially leading to misdiagnosis.
  • Acción
    The firm, Siemens, sent a "Safety Advisory Notice - XP080/14/S" letter dated December 8, 2014, to end users that identified the product, problem, and actions to be taken. Siemens provided instructions to avoid the issue and indicated a software fix would be released as a permanent resolution. The customers were instructed observe this safety notice and comply with the corresponding measure until the update has been fully completed. If you have any questions, contact the Regulatory Technical Specialist at 610-219-2119.

Device

Device Recall Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and Sma...
  • Modelo / Serial
    Material 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470  serial numbers24077 24051 24038 24059 24066 24015 24026 24058 24039 24090 24075
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.
  • Descripción del producto
    Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. || The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
  • 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