Events

Retiro De Equipo (Recall) de Device Recall Stryker inTouch Zoom Critical Care

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 Stryker Medical Div. of Stryker Corporation.

¿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
    45445
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0357-2008
  • Fecha de inicio del evento
    2007-11-02
  • Fecha de publicación del evento
    2007-12-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65552
  • 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
    Hospital Bed - Product Code FNL
  • Causa
    Multiple defects: 1) beds exhibit reverse motions when the fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re.
  • Acción
    Consignees were notified via an Urgent Medical Device Correction letter dated 11/2/07, and instructed to remove the beds from service if they display any unintended motions and informed that one of the firm's field service representatives will visit the facility to make corrections to all beds under recall.

Device

Device Recall Stryker inTouch Zoom Critical Care
  • Modelo / Serial
    All units. (Model Number 2140/Serial Numbers: T01121, T01205, T01350, T01213 thru T01214, T01224, T01014 thru T01036, T01143, T01227, T01211, T01379 thru T01383, T01202, T01053 thru T01099. T01100 thru T01144, T01159, T01179, T01182, T01378, T01186, T01201, T01212, T01057, T01060,T01079,T01200, T01183, T01189, T01223, T01209, T01218, T01172, T01188, T01058, T01171, T01173, T01195, T01203, T01206, T01210, T01216, T01217, T01228, T01176, T01185, TO1193, T01207, T01225, T01215, T01229, T01187, T01311 thru T01320, T01230, T01175, T01180, T01190, T01196, T01037 thru T01052, T01198, T01184, T01192, T01177, T01194, T01204, T01219, T01199, T01191, T01226, T01181, T01197, T01222, T01231 thru T01308,T01208, T01349, T01221, QT01001 thru QT01012, QT01169 and QT01170)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA and Canada
  • Descripción del producto
    Stryker inTouch Zoom Critical Care bed, Model 2140, Stryker Medical, Portage, MI 49002
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA