Events

Rappel de Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators

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 Ohmeda Medical, A division of Datex-Ohmeda, Inc..

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
    31665
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1047-05
  • Date de mise en oeuvre de l'événement
    2005-04-25
  • Date de publication de l'événement
    2005-07-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38318
  • 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
    Incubator, Neonatal - Product Code FMZ
  • Cause
    Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
  • Action
    Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists.

Device

Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • Modèle / numéro de série
    Serial Numbers: HDHE50001 to HDHE50164; HDHF50001 to HDHF50357; HDHF52001 to HDHF52212; HDHF53001 to HDHF53156; HDHF54001 to HDHF54168; HDHG54001 to HDHG54320; HDGD50200 to HDGD50389; HDGE50001 to HDGE50591; HDGF50001 to HDGF50046; HDGF52001 to HDGF52036; HDGF53001 to HDGF53102; HDGF54001 to HDGF54190; HDGG54001 to HDGG54367
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.
  • Description du dispositif
    Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
  • Manufacturer
    Ohmeda Medical, A division of Datex-Ohmeda, Inc.

Manufacturer

Ohmeda Medical, A division of Datex-Ohmeda, Inc.
  • Adresse du fabricant
    Ohmeda Medical, A division of Datex-Ohmeda, Inc., 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA