Events

Retiro De Equipo (Recall) de Device Recall Pathfinder Holter Analyzer

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 Spacelabs Healthcare, Llc.

¿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
    59004
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2611-2011
  • Fecha de inicio del evento
    2011-05-24
  • Fecha de publicación del evento
    2011-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100815
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Causa
    A potential hazard associated with the use of spacelabs healthcare pathfinder holter analyzer software. the second 24 hours of a 48 hours evo recording will not be analyzed.
  • Acción
    Spacelabs Healthcare sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 3, 2011 to all customers. The letter describes the product, problem, and the actions to be taken by the customers. Spacelabs Healthcare recommended that until software upgrades can be done, the customers should weigh the benefits versus the risks when deciding whether or not to continue using the product. Spacelabs Healthcare also recommended that customers advise their staff that the second 24 hours of a 48 hour EVO recording would not be analyzed. Field service engineers will be contacting customers to set up a time and date to install the revised version of the Pathfinder software. Spacelabs will upgrade Pathfinder software regardless of whether the consignees are using EVO recorders to ensure this hazard does not happen in the future. Consignees can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the US, 44 1992 507740 for any questions about this recall.

Device

Device Recall Pathfinder Holter Analyzer
  • Modelo / Serial
    Serial Numbers: PATH-6020, PATH-6412, PATH-9072, PATH-12569, PATH-33320, PATH-33331, PATH-006005, PATH-006043, PATH-006175, PATH-006302, PATH-006314, PATH-006317, PATH-006319, PATH-006332, PATH-006333, PATH-006350, PATH-006351, PATH-006447, PATH-006448, PATH-006449, PATH-006450, PATH-006486, PATH-006487, PATH-006488, PATH-006489, PATH-006502, PATH-006505, PATH-006506, PATH-006527, PATH-006528, PATH-006531, PATH-006537, PATH-006538, PATH-006542, PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006609, PATH-006610, PATH-006612, PATH-006613, PATH-006630, PATH-006631, PATH-006632, PATH-006662, PATH-006663, PATH-006664, PATH-006665, PATH-006666, PATH-006712, PATH-006735, PATH-006736, PATH-006738, PATH-006831, PATH-006839, PATH-006858, and PATH-006861.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including states of CA and NC and countries of Czech Republic, Denmark, Hong Kong, Israel, The Netherlands, and United Kingdom.
  • Descripción del producto
    Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. || The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO Box 7018, Issaquah, WA 98027-7018***Telephone: 425-657-7200***In North America: 800-522-7025***www.spacelabshealthcare.com***". || The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both a automatic mode (tape analyzed without operator intervention) and in an interactive mode; (operator can intervene and affect analysis).
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA