Events

Retiro De Equipo (Recall) de Device Recall Ultrasound Video Gastroscope, Model EG3670URK

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 Pentax of America 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
    Recall
  • ID del evento
    77380
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3067-2017
  • Fecha de inicio del evento
    2017-05-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155880
  • 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
    Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
  • Causa
    Error in reprocessing instructions in revisions 13 and 14 of ifu z845, used with eg-3670urk and eg-3870utk ultrasound gastroscopes. in the disinfection step, the ifu has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. the disinfecting solution, not the cleaning detergent, should be used for this step.
  • Acción
    Recall Notifications were sent to 104 consignees via USPS Certified Mail on 5/23/2017. Included with the Field Safety letter was the customer response form, and the addendum to IFU Z845. These were also posted on Pentax of America web page until the recall is closed.

Device

Device Recall Ultrasound Video Gastroscope, Model EG3670URK
  • Modelo / Serial
    Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411,  H110497, G110360, G110363, G110364, G110371, G110366, G110368,  G110372, H110434, H110447, G110380, H110455, G110298, H110445,  H110449, H110461, G110292, G110346, G110365, H110494, H110495,  H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467,  H110471, H110412, G110289, G110303, G110294, H110420, G110299,  G110300, H110448, H110452, G110386, G110331, H110451, H110493,  G110313, G110314, H110464, H110496, H110433, G110373, G110375,  G110317, H110431, H110417, G110291, G110302, G110369, G110378,  G110335, G110387, G110390, G110392, G110395, G110311, G110327,  G110332, G110382, G110355, G110357, G110287, G110320, H110435,  H110481, H110485, H110486, G110354, G110316, G110318, G110362,  G110393, H110498, H110456, H110457, H110459, G110337, G110356,  H110421, H110429, G110290, G110352, H110470, H110478, G110383,  G110384, G110361.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Ultrasound Video Gastroscope, Model EG-3670URK, || The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
  • Manufacturer
    Pentax of America Inc

Manufacturer

Pentax of America Inc
  • Dirección del fabricante
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA