Retiro De Equipo (Recall) de Device Recall ActiveCare DVT

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 Medical Compression Systems.

¿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
    59812
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0387-2012
  • Fecha de inicio del evento
    2011-08-28
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Sleeve, limb, compressible - Product Code JOW
  • Causa
    This voluntary field action is being undertaken because mcs has received a limited number of reports involving the use of a non-mcs ac/dc adaptor with the activecare dvt and activecare+s.F.T. devices. the firm found that an activecare dvt device may work improperly if connected to a non-mcs ac/dc adaptor with a higher nominal voltage. as specified in each product's user manual, the activecare dvt.
  • Acción
    Medical Compression Systems (DBN) Ltd, sent out "VOLUNTARY FIELD ACTION" letters dated September 15, 2011 to all affected customers. The letter included description of the device and problem. Customers were instructed to check their inventory and make a list of serial numbers of all applicable ActiveCare+S.F.T. and ActiveCare DVT devices in their inventory, include the list on the attached excel file (Field Action Verification Form) and email to maya@mcsmed.com; even if they do not have any such devices. The letter also states that within 15 days from the email, they will receive instructions for the next steps. In addition, the letter stated -YOU MAY CONTINUE TO USE THE ActiveCare+S.F.T.¿ DEVICES WHILE AWAITINGTHE INSTALLATION OF THE OVP. In case you have questions or you need any assistance, you can contact the firm at (317) 485-7887 or e-mail to: maya@mcsmed.com or mahlet@mcsmed.com.

Device

  • Modelo / Serial
    Device Catalog Number A502B-0001-02 and H502B-0001-07
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    ActiveCare DVT || Medical Compression Systems || OR Aqiva, IL || Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema
  • Manufacturer

Manufacturer