Events

Retiro De Equipo (Recall) de A-DEC 511 DENTAL CHAIR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por A-DEC 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
    85860
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-12-08
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Incomplete testing of the power supply (25 80 or 300 watts) used to power dental chairs.

Device

A-DEC 511 DENTAL CHAIR
  • Modelo / Serial
    Model Catalog: 28.1436.00(300 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 28.1479.00(25 WATT POWER SUPPLY) (Lot serial: G5-28 TO G5-31); Model Catalog: 43.0261.00 (300 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 43.0260.00 (300 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 28.1345.00 (80 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 47.2031.00 (80 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 28.1481.00(25 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 28.1480.00(25 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 28.1479.00(25 WATT POWER SUPPLY) (Lot serial: H5-32 TO H5-35); Model Catalog: 28.1436.00(300 WATT POWER SUPPLY) (Lot serial: G5-28 TO G5-31); Model Catalog: 28.1435.00(300 WATT POWER SUPPLY) (Lot serial: G5-28 TO G5-31); Model Catalog: 43.0261.00 (300 WATT POWER SUPPLY) (Lot serial: G5-28 TO G5-31); Model Catalog: 43.0260.00 (300 WATT POWER SUPPLY) (Lot serial: G5-28 TO G5-3
  • Descripción del producto
    A-dec 511 Dental Chair
  • Manufacturer
    A-DEC INC.

Manufacturer

A-DEC INC.
  • Dirección del fabricante
    NEWBERG
  • Empresa matriz del fabricante (2017)
    A-Dec Inc
  • Source
    HC