Events

Rappel de Device Recall Magellan Robotic Catheter System Accessory 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 Hansen 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
    73677
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1564-2016
  • Date de mise en oeuvre de l'événement
    2016-03-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144725
  • 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
    System, catheter control, steerable - Product Code DXX
  • Cause
    Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kgy.
  • Action
    Hansen Medical sent an Urgent Notice Product Recall notification dated March 28, 2016, to all affected customers. The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide the product to the Hansen Medical field representative to assure credit appropriately applied to their account. Customers with questions were instructed to contact their local Hansen Medical representative or call 650-404-5581.

Device

Device Recall Magellan Robotic Catheter System Accessory Kits
  • Modèle / numéro de série
    Lot number 20151117
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to OH, TX. FL, CA and GA.
  • Description du dispositif
    Magellan Robotic Catheter Accessory Kits, || Model number MACC 50 and MACC80. || Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
  • Manufacturer
    Hansen Medical Inc

Manufacturer

Hansen Medical Inc
  • Adresse du fabricant
    Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
  • Société-mère du fabricant (2017)
    Auris Health, Inc.
  • Source
    USFDA