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

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Software error; carestream health inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.E., centimeters or millimeters. as such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. in actuality, the measurement is taken in millimeters. when this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. if the user selects a calc result display as min or max, the values are also interpreted as millimeters when centimeters were expected.
  • Acción
    Carestream sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated November 17, 2016, with a Consignee Notification Acknowledgement (HRA # MA-2016-019) to all affected US consignees via UPS on November 21, 2016. The letter identified the product, the problem, and the action to be taken by the consignee Action to be Taken: When reviewing the worksheet, if a zero value is observed and that calculation field needs to be changed, the calculation needs to be deleted from the worksheet. Once deleted, the user needs to acquire a new calculation from a clinical image. Carestream is currently validating a fix for this problem and your local service representative will be contacting you within the next few weeks to arrange to upgrade your software. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number. 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..


  • Modelo / Serial
    Serial Numbers: US units: 106, 112, 114, 116, 1021, 1037, 1038, 1044, 1057, 1067, 1072, 1074, 1079, 1090; OUS units: 1005, 1006, 1009, 1011, 1015, 1017, 1018, 1020, 1031, 1041, 1042, 1043, 1045, 1081, 1086, 1089.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
  • Descripción del producto
    Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System || Diagnostic ultrasound imaging or fluid flow analysis of the human body
  • Manufacturer


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