Events

Rappel de CMAX SURGICAL TABLE

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

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
    82310
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-09-07
  • 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
    Steris corporation has learned that cmax surigical tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. this could result in the table moving into an unexpected tilt position when the "level" button is depressed on the hand control keypad. the likelihood of this event occurring is remote as the cmax surgical table opertor manual states to always connect the ac power cord to an appropriate ac receptacle as often and as long as possible with the main power switch set to on.

Device

CMAX SURGICAL TABLE
  • Modèle / numéro de série
    Model Catalog: CMAX 110 (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 110 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832050 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832051 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832JEJ (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 220 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832050 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832050 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: CMAX 110 (Lot serial: S/N: 0428208115 TO 0417309157)
  • Description du dispositif
    CMAX SURGICAL TABLE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Steris Plc
  • Source
    HC