Events

Retiro De Equipo (Recall) de Device Recall Foot Control

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 W & H DentalWerk Burmoos GMBH - Site 1.

¿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
    79533
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1351-2018
  • Fecha de inicio del evento
    2017-12-21
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162600
  • 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
    Controller, foot, handpiece and cord - Product Code EBW
  • Causa
    During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type s-n1/s-n2. in case the error occurs, the foot control might not switch back to zero position when the pedal is released. consequently, the motor keeps rotating. if this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient.
  • Acción
    On December 22, 2017 a field safety notice was issued to customers notifying them of the potential problem with the foot controls. On February 15, 2018 a replacement foot control was sent to customers with instructions to unplug the original foot control, cut the cable once disconnected to an electrical source and properly dispose of. The replacement foot control is to be used instead. Questions or concerns can be directed to footcontrol@wh.com

Device

Device Recall Foot Control
  • Modelo / Serial
    REF: 05046200  05046200  05046211  05046210  06202400  06202400  30285000  30285001   Serial number "SN" from to (including) 22400 23429 E02201 E02485 E01011 E01033 E01035 E01071 24315 34040 E01358 E01658 01001 02318
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Foot Controls || Model: S-N1 and S-N2 || Product Usage: || Variable foot control for use with drive units operating mechanical instruments.
  • Manufacturer
    W & H DentalWerk Burmoos GMBH - Site 1

Manufacturer

W & H DentalWerk Burmoos GMBH - Site 1
  • Dirección del fabricante
    W & H DentalWerk Burmoos GMBH - Site 1, Ignaz-Glaser-Strasse 53, Burmoos Austria
  • Empresa matriz del fabricante (2017)
    Pm Privatstiftung
  • Source
    USFDA