Events

Retiro De Equipo (Recall) de Device Recall QRS Diagnostic Universal ECG 12 Channel ECG (IEC),

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 Qrs Diagnostic.

¿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
    61282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1315-2012
  • Fecha de inicio del evento
    2012-02-16
  • Fecha de publicación del evento
    2012-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107721
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    System, ecg analysis - Product Code LOS
  • Causa
    Qrs diagnostic has initiated a recall involving universal ecg 12 lead iec ecg devices. this recall has been initiated because the chest lead wires on these devices may have been improperly labeled. incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretatio.
  • Acción
    QRS Diagnostic sent an Urgent Medical Device Recall letter dated February 9, 2012 via e-mail and mail to all affected consignees. The letter identified the affected product, description of the problem, and actions to be taken. If the affected product have been further distributed, consignees are instructed to notify them at once of the product recall. Consignees were instructed to contact Uni-com immediately for a replacement device. Uni-com will provide this replacement at no charge and will arrange to have the device returned to QRS Diagnostic for correction. Additionally, consignees were instructed to complete the attached Medical Device Correction Receipt Confirmation Form and return to QRS Diagnostic via fax at country code =1-763-559-2961 or email support@QRSDiagnostic.com. For questions contact Technical Support at support@QRSDiagnostic.com or by phone 800-465-8408.

Device

Device Recall QRS Diagnostic Universal ECG 12 Channel ECG (IEC),
  • Modelo / Serial
    2009-42-C102636  2009-42-C102637 2009-42-C102638 2009-42-C102639 2009-42-C102640  2009-42-C102641  2009-42-C102642  2009-42-C102643  2009-42-C102644  2009-42-C102645  2009-42-C102646  2009-42-C102647  2009-42-C102648
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    Worldwide Distribution and the countries of: Belgium, France, Italy, Mali and Senegal.
  • Descripción del producto
    QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. || Product Usage: || The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.
  • Manufacturer
    Qrs Diagnostic

Manufacturer

Qrs Diagnostic
  • Dirección del fabricante
    Qrs Diagnostic, 6901 E Fish Lake Rd Ste 188, Maple Grove MN 55369-5457
  • Empresa matriz del fabricante (2017)
    Qrs Diagnostic
  • Source
    USFDA