Events

Retiro De Equipo (Recall) de Device Recall Advance

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.

¿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
    51202
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1426-2009
  • Fecha de inicio del evento
    2009-02-05
  • Fecha de publicación del evento
    2009-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80386
  • 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
    Gas-Machine, Anesthesia - Product Code BSZ
  • Causa
    Unintended shut-down: the anesthesia machine may start shutting down without human intervention due to a faulty on/standby switch. prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. the failure only affects the electrical portion of the switch. if the clinician does not intervene, the patient could experience hypoventilation leading to h.
  • Acción
    GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.

Device

Device Recall Advance
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.
  • Descripción del producto
    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 9900 Innovation Drive, Mail Stop: RP2138, Wauwatosa WI 53226
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA