Events

Retiro De Equipo (Recall) de DatexOhmeda TruSat

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
    55405
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1814-2010
  • Fecha de inicio del evento
    2010-04-29
  • Fecha de publicación del evento
    2010-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90768
  • 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
    pulse oximeter - Product Code DPZ
  • Causa
    Ge healthcare has recently become aware that the trusat pulse oximeter with external power supply does not comply with current safety standards. it is possible that the external power supply could leak electrical current. this current could cause third degree burns or an abnormal heart rhythm that, if untreated, could lead to death.
  • Acción
    Consignees were sent on 4/29/10 a GE Healthcare "Urgent Medical Device Correction" letter dated 4/22/10. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering, and Home Healthcare Provider. The letter included the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information.

Device

DatexOhmeda TruSat
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH,BELGIUM, BOLIVIA, BRAZIL, CANADA, INDIAN OCEAN TERRITORY, CHILE COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON LIBYAN ARAB JAMAHIRYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MEXICO, MOZAMBIQUE, NEPAL, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM, ZAMBIA.
  • Descripción del producto
    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
  • 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