Events

Retiro De Equipo (Recall) de Regenesis Biomedical PROVANT Wound

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 Regenesis Biomedical 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
    50230
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0887-2009
  • Fecha de publicación del evento
    2009-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75023
  • 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
    diathermy, shortwave - Product Code ILX
  • Causa
    In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. as such, for these few devices, the effectiveness of provant therapy may be impaired.
  • Acción
    Written notification dated September 29, 2008 was sent to consignees by overnight mail notifying them of the nonconformance and providing instructions for return of the affected PROVANT Model 4201A units to Regenesis. Receipt of the notification and return shipping of the units will be verified. Contact Regenesis Biomedical Inc. for additional information at 1-480-970-4970.

Device

Regenesis Biomedical PROVANT Wound
  • Modelo / Serial
    Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    WY, VA, and NC
  • Descripción del producto
    Regenesis Biomedical PROVANT Wound || Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
  • Manufacturer
    Regenesis Biomedical Inc

Manufacturer

Regenesis Biomedical Inc
  • Dirección del fabricante
    Regenesis Biomedical Inc, 1435 N Hayden Rd, Scottsdale AZ 85257-3773
  • Empresa matriz del fabricante (2017)
    Regenesis Biomedical
  • Source
    USFDA