Events

Retiro De Equipo (Recall) de Device Recall Carestream Touch Prime

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 Carestream Health 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
    74652
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2217-2016
  • Fecha de inicio del evento
    2016-07-08
  • Fecha de publicación del evento
    2016-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148112
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. for example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
  • Acción
    The firm, Carestream Health Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter dated 7/7/2016 and response form the end users/customers on 7/8/2016 via Certified Mail, Return Receipt Requested. The letter described the product, problem and actions to be taken. The Customers were instructed not use the generic volume measurement tool until Carestream has updated the system software. In the interim, calculate volumes by using the specific volume tool from the desired calculation package. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact Carestream Customer Care Center as listed above. Carestream has created a software update for Touch Ultrasound to resolve this issue and will update your software. Carestreams representative will contact you and schedule a convenient time to upgrade the software. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910 (available on a 24/7 basis). Outside of the US, please call your local Service support number.

Device

Device Recall Carestream Touch Prime
  • Modelo / Serial
    Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
  • Descripción del producto
    Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound || Diagnostic ultrasound imaging or fluid flow analysis of the human body
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Dirección del fabricante
    Carestream Health Inc, 150 Verona St, Rochester NY 14608-1733
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    USFDA