Events

Rappel de Ohmeda Infant Warmers (with Blenders)

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Ohmeda Medical 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
    15803
  • Date de mise en oeuvre de l'événement
    2013-12-05
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    Oxygen and air wall or tank inlet fittings on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen gas concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate in the affected units. this only impacts ge resuscitation systems with blender.
  • Action
    Product to be modified

Device

Ohmeda Infant Warmers (with Blenders)

Manufacturer

Ohmeda Medical Inc