Events

Rappel de Device Recall Power circuit board assembly kits

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 Cardinal Health 203, 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
    46850
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1467-2008
  • Date de mise en oeuvre de l'événement
    2008-02-22
  • Date de publication de l'événement
    2008-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68339
  • 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
    Assembly kit - Product Code CBK
  • Cause
    The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
  • Action
    An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.

Device

Device Recall Power circuit board assembly kits
  • Modèle / numéro de série
    Lot number: PWRRK0324502, PWRRK0327403, PWRRK0334402, PWRRK0336401, PWRRK0402801, PWRRK0405015, PWRRK0406201, PWRRK0408407, PWRRK0419801, PWRRK0427307, PWRRK0429501, PWRRK0430301, PWRRK0434102, PWRRK0435701, PWRRK0501302, PWRRK0505404, PWRRK0515203, PWRRK0516001, PWRRK0526901, PWRRK0527803.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.
  • Description du dispositif
    Replacement Kit, Power PCBA with DC power cord. REF 11590. || Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
  • Manufacturer
    Cardinal Health 203, Inc

Manufacturer

Cardinal Health 203, Inc
  • Adresse du fabricant
    Cardinal Health 203, Inc, 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA