Events

Rappel de Device Recall HAMILTONC2

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 Hamilton Medical AG.

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
    78599
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1371-2018
  • Date de mise en oeuvre de l'événement
    2018-03-12
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159861
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Cause
    After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
  • Action
    Customers were notified via letter on about 03/12/2018. The letter identified the affected device and described the issue. Instructions for medical facilities are to inspect the batteries for the battery manufacturing date and replace any batteries that are found to be in use for two years or more. Instructions for determining the battery manufacturing date are included in the Medical Device Field Safety Corrective Action Update attached to the letter. Questions or concerns can be directed to Bret Everett at 817-909-0308 or Hamilton Technical Support at 1-800-426-6331.

Device

Device Recall HAMILTONC2
  • Modèle / numéro de série
    Product No. 160001  All Serial Numbers.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Austria, Azerbaijan, Bangladesh, Belarus, Belgian, Bolivia, Brazil, Bulgaria, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Dominican. Rep., Ecuador, Egypt, El Salvador, Estland, Finland, France, Gabon, Germany, Greece, Guatemala, Holland, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mauritius, Macedonia, Mexico, Mongolia, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Scotland, Serbia, Seychelles, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, Sudan, Suriname, Sweden, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, UK , Ukraine, Uruguay, Venezuela, Vietnam, and Yemen.
  • Description du dispositif
    Hamilton-C2 Ventilator Unit || Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG
  • Adresse du fabricant
    Hamilton Medical AG, via Crusch 8, Bonaduz Switzerland
  • Société-mère du fabricant (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA