Events

Rappel de Device Recall SoftReports versions 1.1.6.x and 1.1.7.x

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
    56848
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2714-2011
  • Date de mise en oeuvre de l'événement
    2010-06-23
  • Date de publication de l'événement
    2011-06-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94634
  • 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
    Scc soft computer is issuing a correction for softreports versions 1.1.6.X released 02/2008 and 1.1.7.X released 06/2008. potential hazard - when using softreports layout designer, results displayed in the report may not match the patient information in the report header.
  • Action
    SCC Soft Computers sent a "RISK TO HEALTH NOTIFICATION TASK" letter dated June 9, 2010 to affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were offered an upgrade or hot fix. The letter requested acknowledgement of receipt of the task notification and permission to install the hot fix.

Device

Device Recall SoftReports versions 1.1.6.x and 1.1.7.x
  • Modèle / numéro de série
    Versions 1.1.6.x and 1.1.7.x.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • Description du dispositif
    SoftReports versions 1.1.6.x and 1.1.7.x || SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).
  • 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