Events

Retiro De Equipo (Recall) de Device Recall Shape HF Cardiopulmonary System

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 Shape Medical 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
    68581
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2051-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128263
  • 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, predicted values, pulmonary function - Product Code BTY
  • Causa
    Shape medical has initiated a correction due to a mandatory software upgrade for the shape hf cardiopulmonary testing system prior to use of the impacted dpi lot numbers. use of the incorrect software version with the impacted dpis could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.
  • Acción
    Shape Medical Systems sent an Urgent Medical Device Correction letter dated June 17, 2014, to all affected customers. Customers were informed that new orders of the Disposable Patient interface devices (DPI) will require a software upgrade for the Shape HF Cardiopulmonary Testing System prior to using the new DPIs. Impacted DPIs will be shipped with Instructions to conduct the software upgrade and Technical Service will contact customers shipped the impacted DPIs to confirm receipt and assist with the software upgrade. A Response Form was requested to be returned. Customers with questions were instructed to call Shape Technical Service at 1-888-906-6266 or 651-621-2990.

Device

Device Recall Shape HF Cardiopulmonary System
  • Modelo / Serial
    DPIs with Lot Number 1405006 and higher.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
  • Manufacturer
    Shape Medical Systems, Inc

Manufacturer

Shape Medical Systems, Inc
  • Dirección del fabricante
    Shape Medical Systems, Inc, 5000 Township Pkwy, Saint Paul MN 55110-5852
  • Empresa matriz del fabricante (2017)
    Shape Medical Systems Inc.
  • Source
    USFDA