Events

Rappel de Device Recall SoftLab

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 Soft Computer Consultants, Inc..

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
    77669
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2865-2017
  • Date de mise en oeuvre de l'événement
    2017-05-31
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157452
  • 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, transmission and storage, patient data - Product Code NSX
  • Cause
    Display of lab results based on incorrect loinc code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the emr.
  • Action
    The firm, SCC Soft Computer, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 05/31/2017to its consignees. The letter described the product, problem and actions to be taken. The consignees were informed that the issue will be corrected with a mandatory hotfix. The Consignees were instructed to acknowledge receipt of the recall notice by signing the recall notice and calling Technical Support at 800-763-8522 to grant permission to load the hotfix. For questions or concerns, please call 800-763-8522 Technical Support, available 24/7, and for any adverse reactions/quality problems experienced with the use of this product are to be reported to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax.

Device

Device Recall SoftLab
  • Modèle / numéro de série
    Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
  • Description du dispositif
    SoftLab Software || Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
  • Manufacturer
    Soft Computer Consultants, Inc.

Manufacturer

Soft Computer Consultants, Inc.
  • Adresse du fabricant
    Soft Computer Consultants, Inc., 5400 Tech Data Dr, Clearwater FL 33760-3116
  • Société-mère du fabricant (2017)
    Soft Computer Consultants Inc.
  • Source
    USFDA