Events

Rappel de Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.

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
    56872
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0362-2011
  • Date de mise en oeuvre de l'événement
    2010-06-22
  • Date de publication de l'événement
    2010-11-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94757
  • 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
    Software, blood bank, stand alone products - Product Code MMH
  • Cause
    Scc soft computer is issuing a correction for softbank ii versions: 23.1.2.X, 23.2.0.X, and 25.0.0.X software applications. functionality issue - for clients generating patient history reports using patient>reports>batch reports>history report option in softbank with softreports activated for patient reports, when the report is generated for more than one patient all of the results for the qualif.
  • Action
    SCC Soft Computer notified Customers on June 22, 2010, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated June 11, 2010. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; to grant permission to load the required hot fix, and to make the manual correction. For the manual correction to the datapath for patient report layouts, your SoftBank Support Specialist will Coordinate those changes and your validation of affected environments. If you have any questions, contact (727) 789-0100.

Device

Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.
  • Modèle / numéro de série
    Versions 23.1.2.x, 23.2.0.x, 25.0.0.x
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: U.S. and country of Canada.
  • Description du dispositif
    SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || 23.1:BK040048 || 23.2:BK080020 || 25.0:BK090017 || The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.
  • 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