Events

Retiro De Equipo (Recall) de Device Recall Ultraview SL Command Module/Multiparameter input module

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 Spacelabs Healthcare, Incorporated.

¿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
    37077
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0523-2007
  • Fecha de inicio del evento
    2007-01-03
  • Fecha de publicación del evento
    2007-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49866
  • 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
    multiparameter patient monitor - Product Code DSI
  • Causa
    Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and sp02 alarm limits being frozen. this can result in delay in treatment.
  • Acción
    On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated.

Device

Device Recall Ultraview SL Command Module/Multiparameter input module
  • Modelo / Serial
    Serial numbers 1496-004112, 1496-005720, 1496-004094, 1496-004088, 1496-004089, 1496-004090, 1496-004091, 1496-004092, 1496-004093, 1496-004110, 1496-011601, 1496-004111, 1496-010974, 1496-010975, 1496-010977, 1496-011021, 1496-004174, 1496-004175, 1496-004177, 1496-004178, 1496-004179, 1496-004180, 1496-004165, 1496-004166, 1496-009201, 1496-006236, 1496-006432, 1496-006434, 1496-008163, 1496-008164, 1496-005413, 1496-011026, 1496-006435, 1496-006436, 1496-006829, 1496-006830, 1496-006831, 1496-006832, 1496-006895, 1496-006912, 1496-006913, 1496-006914, 1496-009137, 1496-009138, 1496-004108, 1496-004109, 1496-005761, 1496-008497, 1496-008498, 1496-008499, 1496-008500, 1496-008501, 1496-010056, 1496-010057, 1496-005369, 1496-005388, 1496-005412, 1496-010607, 1496-010053, 1496-005254, 1496-005255, 1496-005256, 1496-005257, 1496-005258, 1496-005326, 1496-005327, 1496-005328, 1496-005329, 1496-004075, 1496-004076, 1496-004077, 1496-004078, 1496-004079, 1496-004080, 1496-004081, 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and worldwide.
  • Descripción del producto
    Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Dirección del fabricante
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA