Events

Rappel de TEST TUBE HEATER K-FTH-1012

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOK (CANADA) INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    96592
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-09-11
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Description du dispositif
    TEST TUBE HEATER power supply component
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.