Events

Retiro De Equipo (Recall) de Device Recall IQecg

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 Brentwood Medical Technology Corp.

¿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
    56016
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2726-2011
  • Fecha de inicio del evento
    2010-05-18
  • Fecha de publicación del evento
    2011-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100321
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Causa
    The recall was initiated because when a user of the iqmanager, iqdevices sdk, and iqic (centricity) software versions listed above accesses the qt dialogue box to either accept or edit the qt value, the qtc value is recalculated using a hodges qtc equation, regardless of patient's age. the software does this without notifying the user of the change from use of the bazett equation, which is utiliz.
  • Acción
    The firm, Midmark, sent an "URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter on May 19, 2010 with an attached Corrective Return Material Authorization (RMA) form via US Postal Service Certified Mail to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their IQecg, IQmanager, or lQiC Centricity software to determine the software version currently in use. If it is a listed product, it is subject to this field corrective action. A sample software label was attached to aid the consignees/customers in locating and identifying the software CD. For customers who have already installed the software, the version number can be identified in the "About" page. Consignees/customers were instructed to complete the enclosed Field RMA form and return it with the affected software to: Quality Assurance Department Midmark Diagnostics Group 1125 West 190 S t. Gardena, CA 90248 In addition, if they further distributed this product, identify customers and notify them at once of this product field corrective action. Replacement software was to be shipped to the consignees/customers upon receipt of the returned software CD. If they require a UPS return shipping label or an on-line download of replacement software, contact Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or 5108. If you have any questions, call Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or QA/RA Manager, Midmark Diagnostics Group 310-516-5116.

Device

Device Recall IQecg
  • Modelo / Serial
    Software Version 8.0.1, 8.3, 8.3.1, 8.3.2
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries of: Algeria, Australia, Canada, France and Saudi Arabia.
  • Descripción del producto
    IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1, 8.3.2 || IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface.
  • Manufacturer
    Brentwood Medical Technology Corp

Manufacturer

Brentwood Medical Technology Corp
  • Dirección del fabricante
    Brentwood Medical Technology Corp, 1125 W 190th St, Gardena CA 90248-4303
  • Empresa matriz del fabricante (2017)
    Midmark Corporation
  • Source
    USFDA