Events

Retiro De Equipo (Recall) de Device Recall Neptune 2 Rover Ultra

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
    63634
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0455-2013
  • Fecha de inicio del evento
    2011-05-24
  • Fecha de publicación del evento
    2012-12-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114396
  • 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
    Beginning may 24, 2011 stryker neptune 2 (n2) waste management systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the rover's ability to roll. this can result in additional strain on the operator, due to multiple exposures resulting in back pain.
  • Acción
    Stryker Instruments sent a "STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to sales.service@stryker.com. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052.

Device

Device Recall Neptune 2 Rover Ultra
  • Modelo / Serial
    Part 0702-002-000 (230v)   Lot 0733700353 through 1036100423
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
  • Descripción del producto
    Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A || REF 0702-002-000, Rx Caution, consult accompanying documents || Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, || The Neptune Waste Management System consists of a mobile rover unit || used to suction and collect fluid waste, small debris and electrocautery || smoke from a surgical site. Mobility allows the rover unit to be || relocated to a waste disposal area where the rovers collection canisters || can be emptied, via the docking station. || Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

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