Events

Retiro De Equipo (Recall) de Device Recall SOMATOM Emotion 16

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
    79428
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1446-2018
  • Fecha de inicio del evento
    2018-02-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162291
  • 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, tomography, computed - Product Code JAK
  • Causa
    To inform customers of possible incorrect tube current calculations by the care dose4d algorithm for head scans based on p.A. (posterior-anterior) or a.P. (anterior-posterior) topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure.
  • Acción
    The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 1301 units will consist of the following: 1. You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3. You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). For further questions, please call (610) 219-4834.

Device

Device Recall SOMATOM Emotion 16
  • Modelo / Serial
    10046789
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationally) Distribution.
  • Descripción del producto
    SOMATOM Emotion 16 || Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA