Events

Rappel de Device Recall Cerner Millennium RadNet Auto Launch Study and Auto Launch Report

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 Cerner Corp.

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
    44739
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1243-2007
  • Date de mise en oeuvre de l'événement
    2007-08-23
  • Date de publication de l'événement
    2007-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64345
  • 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
    radiology software - Product Code LLZ
  • Cause
    Defects in the auto launch functionality make it possible for a mismatch of patient data.
  • Action
    The recalling firm initiated recall via telephone on 8/23/07 to their customers who had the 2007 version in their production environment, explained the reason for recall, and informed them they should turn off the affected functionality. The firm posted details of the situation on their website in two different documents (referred to as a Priority Review Flash), one dated 8/29/07 and the other dated 8/31/07. The 8/31/07 document was also mailed to their customers via certified mail on 9/4/07. The corrected software (EP28822 ver.1) was made available to the firm's clients on 9/7/07 via their website. Beginning 9/18/07, workarounds were discussed via telephone with the clients who had downloaded the software correction which contained a new bug that affected the dictation file. A new software correction to fix the dication file problem was posted on the recalling firm's website on 9/28/07 for clients to download and validate. A Priority review Flash #PR07-0176-2 client notification dated 10/4/07 was also posted on their website and mailed via certified mail return receipt.

Device

Device Recall Cerner Millennium RadNet Auto Launch Study and Auto Launch Report
  • Modèle / numéro de série
    Radiology 2007 Cumulative Production Package 25143
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to health care facilities located in LA, MO, NJ, MS, MI, NE, ND, and AR.
  • Description du dispositif
    Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
  • Manufacturer
    Cerner Corp

Manufacturer

Cerner Corp
  • Adresse du fabricant
    Cerner Corp, 2800 Rockcreek Pkwy, Kansas City MO 64117-2521
  • Source
    USFDA