Events

Rappel de Microsoft Amalga UIS 2009

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 Microsoft Corporation Health Solutions Group.

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
    61673
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1702-2012
  • Date de mise en oeuvre de l'événement
    2012-04-12
  • Date de publication de l'événement
    2012-06-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108695
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    Microsoft amalga uis 2009 has an issue with the display of lab results in the lab details window of the lab result viewer. the lab details view does not freeze/pin the row header when the user scroll horizontally.
  • Action
    Microsoft Corporation Health Solutions Group sent an "URGENT FIELD SAFETY NOTICE" dated April 12, 2012 to all affected customers via e-mail. The letter identifies the product, problem, and actions to be taken by the customers. The firm plans to revise its labeling for Amalga to clarify that the row headers will not be visible as the user scrolls horizontally. Customers were asked to complete and return to the firm a response form via fax at 425-706-7329 or e-mail to vlpigin@microsoft.com.

Device

Microsoft Amalga UIS 2009
  • Modèle / numéro de série
    Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), including subsequent R2 release, Service Packs (SP)1, SP2, SP3.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AR, MA, MD, NC, NY, and WA and the country of China.
  • Description du dispositif
    Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use. || Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs.
  • Manufacturer
    Microsoft Corporation Health Solutions Group

Manufacturer

Microsoft Corporation Health Solutions Group
  • Adresse du fabricant
    Microsoft Corporation Health Solutions Group, 14870 NE 31st Way, Redmond WA 98052
  • Source
    USFDA