Events

Retiro De Equipo (Recall) de TEST TUBE HEATER K-FTH-1012

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COOK (CANADA) 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
    96592
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-09-11
  • 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
    The combination of the test tube heater (k-fth-1012) and power supply (k-aps-300) was recently re-tested for a proposed design change and found to exceed the limits for radiated emissions and is therefore no longer compliant with iec60601-1-2: 2007 (medical electrical equipment - part 1-2 basic safety and essential performance - collateral standard). the radiated rf emissions of the k-aps-300 power supply exceed the limits given in cispr11 group 1 class b by up to 6.3dbuv/m at three metres with very broad peaks occurring at about 85 90mhz and 150mhz.

Device

TEST TUBE HEATER K-FTH-1012
  • Modelo / Serial
    Model Catalog: K-FTH-1012 (Lot serial: UF2324184); Model Catalog: K-FTH-1012 (Lot serial: UF2324181); Model Catalog: K-FTH-1012 (Lot serial: UF2319025); Model Catalog: K-FTH-1012 (Lot serial: UF2319024); Model Catalog: K-FTH-1012 (Lot serial: UF2307313); Model Catalog: K-FTH-1012 (Lot serial: U2480425); Model Catalog: K-FTH-1012 (Lot serial: UF2352096); Model Catalog: K-FTH-1012 (Lot serial: UF2436018); Model Catalog: K-FTH-1012 (Lot serial: UF2433407); Model Catalog: K-FTH-1012 (Lot serial: UF2431410); Model Catalog: K-FTH-1012 (Lot serial: UF2418026); Model Catalog: K-FTH-1012 (Lot serial: UF2418025); Model Catalog: K-FTH-1012 (Lot serial: UF2360912); Model Catalog: K-FTH-1012 (Lot serial: UF2441420)
  • Descripción del producto
    TEST TUBE HEATER power supply component
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.