Events

Rappel de Sunquest Laboratory System.

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 Sunquest Information Systems, 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
    49136
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0214-2009
  • Date de mise en oeuvre de l'événement
    2008-08-01
  • Date de publication de l'événement
    2008-11-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72843
  • 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. - Product Code JQP
  • Cause
    While performing in-house testing for the sunquest laboratory system and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (cache)was not communicated or displayed in the graphic user interface (gui) application so the activity continued. while this error was registered in the error log in the system u.
  • Action
    A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.

Device

Sunquest Laboratory System.
  • Modèle / numéro de série
    Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.
  • Description du dispositif
    Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. || The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.
  • Manufacturer
    Sunquest Information Systems, Inc.

Manufacturer

Sunquest Information Systems, Inc.
  • Adresse du fabricant
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA