Events

Rappel de Device Recall GE Healthcare, Invasive Blood Pressure Care Cables.

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
    62123
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2015-2012
  • Date de mise en oeuvre de l'événement
    2012-06-12
  • Date de publication de l'événement
    2012-07-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109880
  • 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 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.
  • Action
    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.
  • Modèle / numéro de série
    Product ID Number Lot Code  2016995-001 xxxx2010E 2016995-002 xxxx2010D 2016995-003 xxxx2010C 2016995-004 xxxx2010C
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA