Events

Retiro De Equipo (Recall) de Device Recall Horizon Cardiology ECG Management

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 McKesson Provider Technologies - Medical Imaging Group.

¿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
    57436
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0900-2011
  • Fecha de inicio del evento
    2010-06-16
  • Fecha de publicación del evento
    2011-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96241
  • 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
    When importing ecg files from mortara ecg carts using dicom interface, the horizon cardiology ecg management system does not display the amplitudes of the waveform properly.
  • Acción
    McKesson Medical sent an advisory notice letter dated June 16, 2010, to all affected customers. Advisory notice ADV01646 was distributed to 13 affected clinical sites from August 30, 2010 to September 28, 2010. The letters identified the product that is affected, the circumstances under which patient safety issue may occur, the risk, and the immediate actions that need to be taken along with a temporary fix. Customers were instructed to use the ECG cart printout to verify results of procedures acquired by Mortara ECG carts. Users should be aware of the problem when referrring to past ECG procedures and when performing a visual comparison with ECG procedures acquired by Mortara ECG carts. Customers should disable the Glasgow Serial Comparison for ECG procedures. McKesson Support would contact the customer to coordinate the deployment of the software update on all the affected applications and Horizon Cardiology client applications. For any questions regarding this recall, customers should call the Customer Support department at 1-866-777-0202 and speak to their Support Manager.

Device

Device Recall Horizon Cardiology ECG Management
  • Modelo / Serial
    K061905; Versions 12, 12 SP1, 12 SP1 HF2, 12 SP1 HF4, 12.1, 12.1 HF1, 12.1 HF2
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, FL, GA, MA, PA, UT, and WI.
  • Descripción del producto
    Horizon Cardiology ECG Management || This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management may provide a serial comparison of ECG Data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.
  • Manufacturer
    McKesson Provider Technologies - Medical Imaging Group

Manufacturer

McKesson Provider Technologies - Medical Imaging Group
  • Dirección del fabricante
    McKesson Provider Technologies - Medical Imaging Group, 1639 State Rt 10 Ste 100, Parsippany NJ 07054-4506
  • Empresa matriz del fabricante (2017)
    Mckesson Corporation
  • Source
    USFDA