Retiro De Equipo (Recall) de Device Recall Stryker Neptune 3 Rover

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 Instruments 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
    74759
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2630-2016
  • Fecha de inicio del evento
    2016-07-01
  • Fecha de publicación del evento
    2016-08-23
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-06-02
  • Fuente del evento
    USFDA
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Causa
    Stryker initiated a voluntary recall of the 120 v neptune 3 rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.
  • Acción
    Stryker Instruments initiated a voluntary recall of the Stryker Neptune 3 Rover via certified mail on 07/01/2016, due to the potential for the Neptune 3 Rover to experience system errors if there are high levels of electromagnetic interference in the operating room. 1. Immediately review the Recall Notification. 2. Confirm that the Rover serial numbers identified on the Business Reply Form (BRF) are at your facility. 3. A Stryker representative will facilitate the repair of your affected Neptune 3 Rover(s). Please coordinate the availability of the product to assure the repair can be implemented. 4. Please complete and return the Business Reply Form (BRF). Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 5. Fax the completed, signed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. 6. Stryker will document the repair of each unit by serial number. For questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis 269-389-2921 kellyjo.davis@stryker.com

Device

  • Modelo / Serial
    120 V Neptune 3 Rover, Model Number: 0703-001-000; Serial Numbers: 1606300523, 1610606263, 1610903973, 1610904293, 1612303683, 1612303823, 1612303963, 1606300553, 1610606273, 1610904063, 1610904313, 1612303703, 1612303833, 1612303973, 1606300583, 1610606303, 1610904083 , 1610904343, 1612303713, 1612303843 , 1612303993, 1606300593, 1610606323, 1610904103, 1610904353, 1612303723, 1612303853 , 1613106443, 1606300613, 1610606353, 1610904123, 1610904363 , 1612303733, 1612303863, 1613106463, 1606300623, 1610619473, 1610904163, 1610904373 , 1612303743, 1612303873, 1613106583, 1606300643, 1610619483, 1610904173, 1610904403, 1612303763 , 1612303883 , 1613201233, 1606300653, 1610619543, 1610904183, 1612303633, 1612303783, 1612303903, 1613201243 , 1607503463 , 1610619573 , 1610904193, 1612303643, 1612303793, 1612303913, 1613201303,  1607503493, 1610619603 , 1610904203, 1612303663, 1612303813, 612303933, 1613201323, 1610409473, 1610903893, 1610904213, 1612303673
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Domestic:MI, CA, ID, IA VA/DOD: None Foreign: None
  • Descripción del producto
    120 V Neptune 3 Rover, Model Number: 0703-001-000
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA