Events

Rappel de Device Recall Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds

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 Philips Healthcare 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
    56273
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2264-2010
  • Date de mise en oeuvre de l'événement
    2010-07-21
  • Date de publication de l'événement
    2010-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93110
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Cause
    The manifold seal in the philips m1657b water trap used on the philips m1013a intellivue g1, m1019a, intellivue g5, and anesthesia gas modules m1026b/bt may be unintentionally removed when changing the traps. a missing seal may result in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels.
  • Action
    Philips Healthcare issued an "Urgent Device Correction" letter dated July 14, 2010 with an addendum to the Instructions for Use including additional instructions for the replacement of the water trap for the Philips M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia Gas Modules. This addendum is being sent along with the Urgent Medical Device Correction notice to all affected customers. Customers will be requested to incorporate the information contained in the Urgent Medical Device Correction notice and the Addendum to the Instructions for Use with the existing labeling (Instructions for Use) provided with the product. Customers can contact Philips at 1-800-722-9377 for further information..

Device

Device Recall Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds
  • Modèle / numéro de série
    Serial Number range ARZC-0202 to ASBE-0086
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Latvia, Libyan Arab Jamahiriya, Luxembourg, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
  • Description du dispositif
    Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA