Events

Rappel de Device Recall Horizon Medical

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 Mckesson Information Solutions LLC.

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
    59365
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3035-2011
  • Date de mise en oeuvre de l'événement
    2011-02-02
  • Date de publication de l'événement
    2011-08-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102413
  • 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 radiological image processing - Product Code LLZ
  • Cause
    Images for one patient may appear in the study of another patient.
  • Action
    Mckesson Medical Imaging Group sent a URGENT FIELD SAFETY NOTICE letter dated June 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On February 2, 2011, the McKesson Medical Imaging company initiated a process for applying an image display software update to the HMI systems at the hospital site that initiated the complaint. They were advised to contact McKesson Customer Support at 1-800-663-2533, to indicate whether they would like to receive the software update. They were advised to distribute the notification to all those within their organization who need to be aware and to alert other parties affiliated with their organization that are affected by this advisory notice.

Device

Device Recall Horizon Medical
  • Modèle / numéro de série
    Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the United Kingdom.
  • Description du dispositif
    Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. || Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
  • Manufacturer
    Mckesson Information Solutions LLC

Manufacturer

Mckesson Information Solutions LLC
  • Adresse du fabricant
    Mckesson Information Solutions LLC, 5995 Winward Plaza, Information Technology Business, Alpharetta GA 30005
  • Source
    USFDA