Events

Rappel de Device Recall GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67370
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0982-2014
  • Date de mise en oeuvre de l'événement
    2013-11-27
  • Date de publication de l'événement
    2014-02-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125349
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    Ge has become aware of multiple issues affecting the dash 3000/4000/5000 patient monitor and dash port 2 docking station: dash: 1. dash stops communicating on the unity network resulting in loss of monitoring at the carescape" cic pro central station*. 2. dash displays distorted ecg waveforms in combination monitoring mode. 3. dash incorrectly becomes time master on the unity network¿. 4.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated November 27,2013. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative).

Device

Device Recall GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Doc...
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) including DC and PR; and Internationally to: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANDA, CARIBBEAN, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MAURITIUS, MEXICO, MOLDOVIA, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, TANZANIA, THAILAND, TRINIDAD TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN, and ZIMBABWE.
  • Description du dispositif
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA