Events

Retiro De Equipo (Recall) de Device Recall Sunquest Laboratory

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sunquest Information Systems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    62768
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2332-2012
  • Fecha de inicio del evento
    2012-03-15
  • Fecha de publicación del evento
    2012-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111675
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    Sunquest is recalling sunquest laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the windows-based merge application is used and the "event merge across patients" option is used, a receiving system (for example a his or copath system) may interpret the event merge as a full patient merge. this occurs because a trigger from the laboratory system for the event.
  • Acción
    The firm, Sunquest, sent an "Urgent- Product Safety Notice: PSN-12-02" dated March 15, 2012 to all their customers who purchased the Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1. The notice described the product, the problems and the actions to be taken. Customers were instructed to request the software correction by creating a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Customers with questions were instructed to contact Client support at (877) 239-6337 for US and Canadian Sites and at +44 (0) 161 335 0562 for international sites.

Device

Device Recall Sunquest Laboratory
  • Modelo / Serial
    Version versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.
  • Descripción del producto
    Sunquest Laboratory || Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.
  • Manufacturer
    Sunquest Information Systems, Inc.

Manufacturer

Sunquest Information Systems, Inc.
  • Dirección del fabricante
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA