Events

Rappel de Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.

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 Datex Ohmeda, Inc. dba GE Healthcare.

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
    49097
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0305-2009
  • Date de mise en oeuvre de l'événement
    2008-06-20
  • Date de publication de l'événement
    2008-11-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72753
  • 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
    Neonatal lncubator. - Product Code FMZ
  • Cause
    Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
  • Action
    A notification letter (Urgent Medical Device Correction) was sent to consignees on 06/20/08. The notification letter addressed healthcare professionals, including neonatal, infection control and nursing departments at medical facilities. In add tion, the letter advised of revisions to the current Giraffe OmniBed¿¿ cleaning instructions contained in the product Operators Manual. Instructions were enclosed with the notification letter and are intended to supplement those already present in the manual. Contact the GE Healthcare Technical Support center at 1-800-558-7044 for questions or additional information. If outside of the USA, please contact your local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.
  • Modèle / numéro de série
    All lots.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: The devices were widely distributed to national and international medical facilities.
  • Description du dispositif
    Giraffe OmniBed¿, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. || The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.
  • Manufacturer
    Datex Ohmeda, Inc. dba GE Healthcare

Manufacturer

Datex Ohmeda, Inc. dba GE Healthcare
  • Adresse du fabricant
    Datex Ohmeda, Inc. dba GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA