Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare, Invasive Blood Pressure Care Cables.

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 GE Healthcare, LLC.

¿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
    62123
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2015-2012
  • Fecha de inicio del evento
    2012-06-12
  • Fecha de publicación del evento
    2012-07-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109880
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Ge healthcare has become aware through complaints of a potential safety issue with its invasive blood pressure cable made for use with a spectramed / bd invasive blood pressure transducer. due to use of an incorrect o-ring, the mating of the cable with the transducer is faulty. this situation inhibits blood pressure measurement from being monitored correctly.
  • Acción
    GE Healthcare sent a Urgent Medical Device Correction letter dated June 12, 2012, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Inforamtion. Advised customers to discontinue use, further distribution and to contact their customers. Please return any defective Invasive Blood Pressure Cables by isolating all affected product and completing the attached Confirmation form/fax back per its instructions. This step is required to confirm receipt of communications with all customers. If you have any questions or concerns regarding this notification, please contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation: 8:00 am EST to 6:00 pm EST. .

Device

Device Recall GE Healthcare, Invasive Blood Pressure Care Cables.
  • Modelo / Serial
    Product ID Number Lot Code  2016995-001 xxxx2010E 2016995-002 xxxx2010D 2016995-003 xxxx2010C 2016995-004 xxxx2010C
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of AK, CA, IL, MS, NJ, PR, SD, TN, TX, and VA. and the countries of ARGENTIAN, AUSTRALIA, BELGIUM, CHINA, GERMANY, ALGERIA, ECUADOR, EGYPT, FINLAND, UNITED KINGDOM, JORDAN, JAPAN, MOROCCO, MAURITUS, NETHERLANDS, OMAN, PERU, SEBIA, SUDI ARABIA, SINGAPORE, EL SALVADOR, TURKEY, URUGUAY and SOUTH AFRICA.
  • Descripción del producto
    GE Healthcare, Invasive Blood Pressure Care Cables. || Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA