Events

Rappel de Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1

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 SCC Soft Computer.

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
    56274
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0074-2011
  • Date de mise en oeuvre de l'événement
    2004-11-30
  • Date de publication de l'événement
    2010-10-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93113
  • 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
    Medical computers and software - Product Code LNX
  • Cause
    Soft query results reporting versions 2.2.0.6.3 and 2.2.0.7.1 his may display incorrect collection data for a procedure or test result. clients using hbo star rr interface to query for results on a canceled test may see the previous occurrence of the test with the current date and time displayed as the collection date and time instead of the correct collection date and time sent by the scc interf.
  • Action
    Client Notification Task Verbiage was sent through the Task Management System on December 3, 2003, identifying the software issue, the clinical impact, and corrective action. Customers were informed that the HIS may display incorrect collection data. Customers received the SQRR Service Pack with revised software, which will will not produce inaccurate information if there are no verified results. Customers were to acknowledge receipt of the task notification and indicate whether they would like the corrected software. SCC Soft Computer proprietary Task Management System is used to manage client communication. Clients use this system to request services, receive and provide software updates for any issue. Customers can contact SCC Soft Computer at 727-789-0100.

Device

Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1
  • Modèle / numéro de série
    Versions 2.2.0.6.3 and 2.2.0.7.1.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: including states of GA, LA, and NH.
  • Description du dispositif
    Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. || Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.
  • Manufacturer
    SCC Soft Computer

Manufacturer

SCC Soft Computer
  • Adresse du fabricant
    SCC Soft Computer, 5400 Tech Data Drive, Clearwater FL 33760
  • Société-mère du fabricant (2017)
    Soft Computer Consultants Inc.
  • Source
    USFDA