Events

Rappel de Device Recall 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
    61021
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1191-2012
  • Date de mise en oeuvre de l'événement
    2012-01-11
  • Date de publication de l'événement
    2012-03-08
  • 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=107082
  • 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
    The problem occurs when a user filters the data in amalga datagrid to exclude specific values. if the field specified in the filter criteria contains null values, the filtering will exclude those records as well.
  • Action
    Microsoft Corporation Health Solutions Group sent a "Urgent Field Safety Notice" email dated January 19, 2012, to all affected customers. Notification of customers in China is still pending due to the Chinese New Year Holiday. Customers were instructed to : 1. If the user notices varying row counts or inconsistent values in a given column and they are using the exclude filter, they may have to look for alternative ways to filter the data that do not use the above mentioned filter conditions. 2. To avoid the indicated issue in your implementation there are two steps to be taken: a. Ensure that all parsers are inserting empty strings () rather than NULL when ingesting data into the system and b. Identify all Baseview definitions (i.e. the sql view that a baseview is accessing) that include an outer join and update those definitions to include the ISNULL replacement function [e.g. ISNULL( column_name, )] on any columns which may return NULL due to a non-matching row in the outer join tab As of January 23, 2012 The firm's members of Services Team have spoken by phone with representative of every customer. Customers should call 425-882-8080 for any questions about this recall.

Device

Device Recall Microsoft Amalga UIS 2009
  • Modèle / numéro de série
    2009; R2; R2 SP1; R2 SP2, R2 SP3, RTM.
  • 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, CA, KY, HI, FL, MA, MD, MN, NC, NJ, NY, WA, WI and countries China, Switzerland, and United Kingdom.
  • Description du dispositif
    Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS), 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